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Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716675
Recruitment Status : Completed
First Posted : March 23, 2016
Results First Posted : February 8, 2022
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Biological: VRC01
Biological: Placebo for VRC01
Enrollment 2699
Recruitment Details  
Pre-assignment Details Participants were randomly assigned to the placebo, low-dose VRC01, or high-dose VRC01 arm. The pooled VRC01 arm represents participants assigned to low-dose or high-dose VRC01 and is the primary comparison group for the primary analysis of prevention efficacy.
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01
Hide Arm/Group Description Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Period Title: Overall Study
Started [1] 903 899 897
Modified Intent-to-treat Population [2] 898 895 894
Completed 703 702 686
Not Completed 200 197 211
Reason Not Completed
Death             2             3             0
Physician Decision             2             1             1
Lost to Follow-up             100             87             99
Withdrawal by Subject             22             25             20
Protocol Violation             0             3             1
Participant Unable to Adhere to Visit Schedule             36             31             42
Other             38             47             48
[1]
Enrollment is concurrent with receiving the first infusion (safety analyses)
[2]
Participants excluded from MITT if HIV positive at enrollment or randomized/enrolled more than once (efficacy analyses)
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Total
Hide Arm/Group Description Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. Total of all reporting groups
Overall Number of Baseline Participants 903 899 897 2699
Hide Baseline Analysis Population Description
Safety Population
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 903 participants 899 participants 897 participants 2699 participants
28
(18 to 50)
28
(18 to 52)
27
(18 to 50)
28
(18 to 52)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 903 participants 899 participants 897 participants 2699 participants
Less than 18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18 - 20 years
95
  10.5%
94
  10.5%
106
  11.8%
295
  10.9%
21 - 30 years
496
  54.9%
474
  52.7%
480
  53.5%
1450
  53.7%
31 - 40 years
232
  25.7%
253
  28.1%
208
  23.2%
693
  25.7%
41 - 50 years
80
   8.9%
77
   8.6%
103
  11.5%
260
   9.6%
Above 50 years
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 903 participants 899 participants 897 participants 2699 participants
Female
11
   1.2%
7
   0.8%
8
   0.9%
26
   1.0%
Male
892
  98.8%
892
  99.2%
889
  99.1%
2673
  99.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 903 participants 899 participants 897 participants 2699 participants
Hispanic or Latino
532
  58.9%
517
  57.5%
495
  55.2%
1544
  57.2%
Not Hispanic or Latino
371
  41.1%
382
  42.5%
402
  44.8%
1155
  42.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 903 participants 899 participants 897 participants 2699 participants
American Indian or Alaska Native
6
   0.7%
7
   0.8%
3
   0.3%
16
   0.6%
Asian
22
   2.4%
29
   3.2%
18
   2.0%
69
   2.6%
Native Hawaiian or Other Pacific Islander
4
   0.4%
2
   0.2%
2
   0.2%
8
   0.3%
Black or African American
132
  14.6%
132
  14.7%
144
  16.1%
408
  15.1%
White
286
  31.7%
272
  30.3%
293
  32.7%
851
  31.5%
More than one race
32
   3.5%
32
   3.6%
24
   2.7%
88
   3.3%
Unknown or Not Reported
421
  46.6%
425
  47.3%
413
  46.0%
1259
  46.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 903 participants 899 participants 897 participants 2699 participants
United States
460
  50.9%
464
  51.6%
457
  50.9%
1381
  51.2%
Brazil
51
   5.6%
49
   5.5%
51
   5.7%
151
   5.6%
Peru
380
  42.1%
374
  41.6%
377
  42.0%
1131
  41.9%
Switzerland
12
   1.3%
12
   1.3%
12
   1.3%
36
   1.3%
1.Primary Outcome
Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Hide Description Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Time Frame Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Measure Type: Count of Participants
Unit of Measure: Participants
Pain None
812
  89.9%
794
  88.3%
805
  89.7%
1599
  89.0%
Mild
90
  10.0%
104
  11.6%
88
   9.8%
192
  10.7%
Moderate
1
   0.1%
1
   0.1%
4
   0.4%
5
   0.3%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Tenderness None
754
  83.5%
741
  82.4%
759
  84.6%
1500
  83.5%
Mild
145
  16.1%
153
  17.0%
133
  14.8%
286
  15.9%
Moderate
4
   0.4%
5
   0.6%
5
   0.6%
10
   0.6%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain and/or Tenderness None
718
  79.5%
702
  78.1%
720
  80.3%
1422
  79.2%
Mild
180
  19.9%
191
  21.2%
170
  19.0%
361
  20.1%
Moderate
5
   0.6%
6
   0.7%
7
   0.8%
13
   0.7%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Hide Description Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Time Frame Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema/Redness None
877
  97.1%
878
  97.7%
882
  98.3%
1760
  98.0%
Gr 1: 2.5 to less than 5cm
17
   1.9%
13
   1.4%
13
   1.4%
26
   1.4%
Gr 2: 5 to less than 10cm
9
   1.0%
8
   0.9%
2
   0.2%
10
   0.6%
Gr 3: >= 10cm
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gr 4: complications AE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Induration/Swelling None
896
  99.2%
894
  99.4%
894
  99.7%
1788
  99.6%
Gr 1: 2.5 to less than 5cm
7
   0.8%
4
   0.4%
2
   0.2%
6
   0.3%
Gr 2: 5 to less than 10cm
0
   0.0%
1
   0.1%
1
   0.1%
2
   0.1%
Gr 3: >= 10cm
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gr 4: complications AE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Erythema and/or Induration None
874
  96.8%
876
  97.4%
880
  98.1%
1756
  97.8%
Gr 1: 2.5 to less than 5cm
20
   2.2%
15
   1.7%
14
   1.6%
29
   1.6%
Gr 2: 5 to less than 10cm
9
   1.0%
8
   0.9%
3
   0.3%
11
   0.6%
Gr 3: >= 10cm
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gr 4: complications AE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Hide Description Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Time Frame Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Measure Type: Count of Participants
Unit of Measure: Participants
Malaise and/or fatigue None
664
  73.5%
672
  74.7%
691
  77.0%
1363
  75.9%
Mild
197
  21.8%
182
  20.2%
169
  18.8%
351
  19.5%
Moderate
39
   4.3%
45
   5.0%
36
   4.0%
81
   4.5%
Severe
3
   0.3%
0
   0.0%
1
   0.1%
1
   0.1%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia None
809
  89.6%
802
  89.2%
820
  91.4%
1622
  90.3%
Mild
81
   9.0%
76
   8.5%
61
   6.8%
137
   7.6%
Moderate
13
   1.4%
21
   2.3%
15
   1.7%
36
   2.0%
Severe
0
   0.0%
0
   0.0%
1
   0.1%
1
   0.1%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Headache None
728
  80.6%
714
  79.4%
731
  81.5%
1445
  80.5%
Mild
146
  16.2%
147
  16.4%
137
  15.3%
284
  15.8%
Moderate
28
   3.1%
35
   3.9%
29
   3.2%
64
   3.6%
Severe
1
   0.1%
3
   0.3%
0
   0.0%
3
   0.2%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea None
821
  90.9%
814
  90.5%
812
  90.5%
1626
  90.5%
Mild
74
   8.2%
74
   8.2%
77
   8.6%
151
   8.4%
Moderate
8
   0.9%
10
   1.1%
8
   0.9%
18
   1.0%
Severe
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.1%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Vomiting None
889
  98.4%
873
  97.1%
881
  98.2%
1754
  97.7%
Mild
12
   1.3%
24
   2.7%
12
   1.3%
36
   2.0%
Moderate
2
   0.2%
2
   0.2%
4
   0.4%
6
   0.3%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chills None
857
  94.9%
843
  93.8%
861
  96.0%
1704
  94.9%
Mild
41
   4.5%
45
   5.0%
29
   3.2%
74
   4.1%
Moderate
5
   0.6%
11
   1.2%
6
   0.7%
17
   0.9%
Severe
0
   0.0%
0
   0.0%
1
   0.1%
1
   0.1%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Arthralgia None
861
  95.3%
848
  94.3%
869
  96.9%
1717
  95.6%
Mild
39
   4.3%
44
   4.9%
21
   2.3%
65
   3.6%
Moderate
3
   0.3%
7
   0.8%
7
   0.8%
14
   0.8%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Max. Systemic Symptoms None
556
  61.6%
546
  60.7%
563
  62.8%
1109
  61.7%
Mild
286
  31.7%
277
  30.8%
273
  30.4%
550
  30.6%
Moderate
57
   6.3%
72
   8.0%
59
   6.6%
131
   7.3%
Severe
4
   0.4%
4
   0.4%
2
   0.2%
6
   0.3%
Potentially Life-threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Increased Body Temperature None
880
  97.5%
879
  97.8%
870
  97.0%
1749
  97.4%
Mild
14
   1.6%
11
   1.2%
14
   1.6%
25
   1.4%
Moderate
7
   0.8%
7
   0.8%
12
   1.3%
19
   1.1%
Severe
1
   0.1%
2
   0.2%
1
   0.1%
3
   0.2%
Potentially Life-threatening
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
Hide Description For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Median (Inter-Quartile Range)
Unit of Measure: U/L
ALT (SGPT) (U/L)- Week 0 Number Analyzed 903 participants 899 participants 897 participants 1796 participants
25
(17 to 35)
24
(17 to 36)
24
(17 to 35)
24
(17 to 35)
ALT (SGPT) (U/L)- Week 8 Number Analyzed 865 participants 855 participants 856 participants 1711 participants
24
(17 to 35)
24
(16 to 36)
24
(17 to 33)
24
(17 to 35)
ALT (SGPT) (U/L)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
23
(17 to 35)
23
(17 to 34)
24
(17 to 34)
23
(17 to 34)
ALT (SGPT) (U/L)- Week 24 Number Analyzed 811 participants 820 participants 805 participants 1625 participants
24
(17 to 35)
23
(17 to 33)
23
(16 to 33)
23
(16 to 33)
ALT (SGPT) (U/L)- Week 32 Number Analyzed 802 participants 797 participants 787 participants 1584 participants
24
(17 to 34)
23
(17 to 34)
23
(16 to 33)
23
(16 to 33)
ALT (SGPT) (U/L)- Week 40 Number Analyzed 790 participants 784 participants 765 participants 1549 participants
23
(16 to 33)
22
(16 to 33)
22
(16 to 33)
22
(16 to 33)
ALT (SGPT) (U/L)- Week 48 Number Analyzed 772 participants 776 participants 754 participants 1530 participants
23
(16 to 33)
23
(16 to 33)
22
(15 to 31)
22
(16 to 32)
ALT (SGPT) (U/L)- Week 56 Number Analyzed 754 participants 763 participants 749 participants 1512 participants
22
(16 to 34)
22
(16 to 33)
22
(16 to 30)
22
(16 to 32)
ALT (SGPT) (U/L)- Week 64 Number Analyzed 737 participants 748 participants 722 participants 1470 participants
22
(16 to 33)
22
(16 to 33)
22
(15 to 31)
22
(16 to 32)
ALT (SGPT) (U/L)- Week 72 Number Analyzed 721 participants 731 participants 718 participants 1449 participants
22
(16 to 32)
22
(16 to 31)
22
(16 to 31)
22
(16 to 31)
5.Primary Outcome
Title Chemistry and Hematology Laboratory Measures - Creatinine
Hide Description For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Creatinine (mg/dL)- Week 0 Number Analyzed 903 participants 899 participants 897 participants 1796 participants
0.86
(0.76 to 0.98)
0.86
(0.75 to 0.97)
0.86
(0.76 to 0.99)
0.86
(0.75 to 0.98)
Creatinine (mg/dL)- Week 8 Number Analyzed 866 participants 855 participants 856 participants 1711 participants
0.87
(0.77 to 0.98)
0.86
(0.76 to 0.97)
0.88
(0.77 to 0.99)
0.87
(0.77 to 0.98)
Creatinine (mg/dL)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
0.88
(0.78 to 0.99)
0.87
(0.77 to 0.98)
0.87
(0.78 to 0.99)
0.87
(0.77 to 0.99)
Creatinine (mg/dL)- Week 24 Number Analyzed 812 participants 820 participants 805 participants 1625 participants
0.87
(0.77 to 0.99)
0.88
(0.78 to 0.99)
0.88
(0.77 to 1)
0.88
(0.77 to 1)
Creatinine (mg/dL)- Week 32 Number Analyzed 802 participants 797 participants 787 participants 1584 participants
0.88
(0.77 to 0.99)
0.87
(0.78 to 0.99)
0.87
(0.77 to 1)
0.87
(0.78 to 0.99)
Creatinine (mg/dL)- Week 40 Number Analyzed 791 participants 786 participants 765 participants 1551 participants
0.88
(0.78 to 0.99)
0.88
(0.78 to 1)
0.88
(0.78 to 1)
0.88
(0.78 to 1)
Creatinine (mg/dL)- Week 48 Number Analyzed 772 participants 776 participants 754 participants 1530 participants
0.88
(0.78 to 1)
0.89
(0.79 to 0.99)
0.89
(0.78 to 1.01)
0.89
(0.79 to 1)
Creatinine (mg/dL)- Week 56 Number Analyzed 754 participants 763 participants 750 participants 1513 participants
0.88
(0.78 to 0.99)
0.89
(0.78 to 1)
0.88
(0.8 to 1)
0.88
(0.79 to 1)
Creatinine (mg/dL)- Week 64 Number Analyzed 737 participants 748 participants 722 participants 1470 participants
0.88
(0.78 to 1)
0.89
(0.8 to 1)
0.89
(0.79 to 1)
0.89
(0.79 to 1)
Creatinine (mg/dL)- Week 72 Number Analyzed 722 participants 732 participants 718 participants 1450 participants
0.89
(0.79 to 0.99)
0.88
(0.8 to 1)
0.89
(0.8 to 1.01)
0.89
(0.8 to 1)
6.Primary Outcome
Title Chemistry and Hematology Laboratory Measures - Hemoglobin
Hide Description For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Median (Inter-Quartile Range)
Unit of Measure: g/dL
Hemoglobin (g/dL)- Week 0 Number Analyzed 902 participants 899 participants 897 participants 1796 participants
14.9
(14.1 to 15.6)
14.8
(14.2 to 15.6)
14.9
(14.1 to 15.6)
14.8
(14.2 to 15.6)
Hemoglobin (g/dL)- Week 8 Number Analyzed 865 participants 853 participants 855 participants 1708 participants
14.7
(14.1 to 15.5)
14.7
(13.9 to 15.4)
14.8
(14.1 to 15.5)
14.7
(14 to 15.4)
Hemoglobin (g/dL)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
14.7
(14 to 15.5)
14.7
(14 to 15.4)
14.7
(14 to 15.4)
14.7
(14 to 15.4)
Hemoglobin (g/dL)- Week 24 Number Analyzed 812 participants 819 participants 805 participants 1624 participants
14.6
(14 to 15.4)
14.6
(13.9 to 15.3)
14.7
(14 to 15.3)
14.7
(14 to 15.3)
Hemoglobin (g/dL)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
14.6
(14 to 15.3)
14.6
(13.9 to 15.3)
14.7
(13.9 to 15.3)
14.6
(13.9 to 15.3)
Hemoglobin (g/dL)- Week 40 Number Analyzed 790 participants 786 participants 765 participants 1551 participants
14.6
(13.9 to 15.5)
14.5
(13.8 to 15.3)
14.6
(13.9 to 15.4)
14.6
(13.8 to 15.3)
Hemoglobin (g/dL)- Week 48 Number Analyzed 772 participants 775 participants 753 participants 1528 participants
14.6
(13.9 to 15.4)
14.6
(13.8 to 15.3)
14.6
(13.8 to 15.3)
14.6
(13.8 to 15.3)
Hemoglobin (g/dL)- Week 56 Number Analyzed 754 participants 763 participants 750 participants 1513 participants
14.6
(13.9 to 15.4)
14.6
(13.7 to 15.3)
14.6
(13.9 to 15.3)
14.6
(13.8 to 15.3)
Hemoglobin (g/dL)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
14.6
(13.8 to 15.3)
14.5
(13.7 to 15.4)
14.6
(13.8 to 15.3)
14.5
(13.8 to 15.3)
Hemoglobin (g/dL)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
14.5
(13.9 to 15.3)
14.5
(13.7 to 15.2)
14.5
(13.8 to 15.3)
14.5
(13.7 to 15.3)
7.Primary Outcome
Title Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Hide Description For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Median (Inter-Quartile Range)
Unit of Measure: cells/cubic mm
Lymphocytes (cells/cubic mm)- Week 0 Number Analyzed 902 participants 899 participants 897 participants 1796 participants
1988.5
(1620 to 2363)
1980
(1600 to 2406)
1971
(1645 to 2370)
1978.5
(1620 to 2392)
Lymphocytes (cells/cubic mm)- Week 8 Number Analyzed 865 participants 851 participants 854 participants 1705 participants
1926
(1610 to 2296)
1904
(1571 to 2264)
1947.5
(1596 to 2310)
1930
(1590 to 2294)
Lymphocytes (cells/cubic mm)- Week 16 Number Analyzed 840 participants 836 participants 832 participants 1668 participants
1927.5
(1600 to 2289)
1896
(1593.5 to 2325.5)
1915.5
(1592 to 2349.5)
1900.5
(1593 to 2339)
Lymphocytes (cells/cubic mm)- Week 24 Number Analyzed 811 participants 819 participants 805 participants 1624 participants
1950
(1600 to 2295)
1925
(1580 to 2320)
1911
(1600 to 2336)
1920
(1596 to 2330.5)
Lymphocytes (cells/cubic mm)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
1957
(1610 to 2300)
1930
(1560 to 2300)
1900
(1580 to 2309.5)
1920
(1570 to 2304)
Lymphocytes (cells/cubic mm)- Week 40 Number Analyzed 789 participants 786 participants 765 participants 1551 participants
1890
(1560 to 2294)
1900
(1525 to 2295)
1879
(1570 to 2250)
1890
(1550 to 2263)
Lymphocytes (cells/cubic mm)- Week 48 Number Analyzed 772 participants 774 participants 752 participants 1526 participants
1923.5
(1600 to 2271)
1923
(1570 to 2320)
1870
(1570 to 2260)
1900
(1570 to 2290)
Lymphocytes (cells/cubic mm)- Week 56 Number Analyzed 754 participants 762 participants 750 participants 1512 participants
1910
(1582 to 2290)
1887.5
(1565 to 2310)
1900.5
(1600 to 2294)
1895.5
(1582.5 to 2300)
Lymphocytes (cells/cubic mm)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
1922
(1593 to 2300)
1890
(1580 to 2311)
1870
(1570 to 2260)
1880
(1580 to 2300)
Lymphocytes (cells/cubic mm)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
1940
(1590 to 2236)
1930
(1542 to 2267)
1900
(1560 to 2280)
1910
(1556 to 2270)
Neutrophils (cells/cubic mm)- Week 0 Number Analyzed 902 participants 899 participants 897 participants 1796 participants
3586
(2754 to 4495)
3593
(2720 to 4514)
3534
(2705 to 4505)
3571.5
(2715 to 4510.5)
Neutrophils (cells/cubic mm)- Week 8 Number Analyzed 865 participants 851 participants 854 participants 1705 participants
3410
(2727 to 4236)
3460
(2650 to 4540)
3424
(2798 to 4460)
3437
(2708 to 4502)
Neutrophils (cells/cubic mm)- Week 16 Number Analyzed 840 participants 836 participants 832 participants 1668 participants
3378
(2578 to 4355)
3377
(2549.5 to 4246)
3360
(2600 to 4305)
3361.5
(2580 to 4283)
Neutrophils (cells/cubic mm)- Week 24 Number Analyzed 811 participants 819 participants 805 participants 1624 participants
3330
(2610 to 4212)
3417
(2554 to 4430)
3306
(2538 to 4350)
3357.5
(2550 to 4400)
Neutrophils (cells/cubic mm)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
3344
(2543 to 4300)
3360
(2501 to 4380)
3336
(2582.5 to 4289)
3350
(2550 to 4352)
Neutrophils (cells/cubic mm)- Week 40 Number Analyzed 789 participants 786 participants 765 participants 1551 participants
3310
(2560 to 4195)
3260
(2500 to 4400)
3300
(2516 to 4200)
3287
(2500 to 4320)
Neutrophils (cells/cubic mm)- Week 48 Number Analyzed 772 participants 774 participants 752 participants 1526 participants
3322
(2675 to 4344.5)
3284.5
(2560 to 4240)
3266.5
(2583 to 4205)
3278
(2580 to 4224)
Neutrophils (cells/cubic mm)- Week 56 Number Analyzed 754 participants 762 participants 750 participants 1512 participants
3340
(2612 to 4320)
3238.5
(2500 to 4290)
3200
(2519 to 4100)
3212.5
(2508 to 4192.5)
Neutrophils (cells/cubic mm)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
3245
(2560 to 4180)
3240
(2495 to 4275)
3228
(2576 to 4100)
3230
(2520 to 4190)
Neutrophils (cells/cubic mm)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
3286.5
(2530 to 4123)
3245
(2420 to 4180)
3304
(2550 to 4298)
3272
(2500 to 4259)
8.Primary Outcome
Title Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Hide Description For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Median (Inter-Quartile Range)
Unit of Measure: 1000 cells/cubic mm
WBC (1000 cells/cubic mm)- Week 0 Number Analyzed 902 participants 899 participants 897 participants 1796 participants
6.33
(5.28 to 7.5)
6.4
(5.28 to 7.66)
6.3
(5.2 to 7.5)
6.3
(5.25 to 7.6)
WBC (1000 cells/cubic mm)- Week 8 Number Analyzed 865 participants 853 participants 855 participants 1708 participants
6.2
(5.2 to 7.4)
6.1
(5.01 to 7.41)
6.2
(5.1 to 7.5)
6.12
(5.07 to 7.5)
WBC (1000 cells/cubic mm)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
6.1
(4.99 to 7.3)
6.1
(5 to 7.3)
6.1
(5.01 to 7.33)
6.1
(5 to 7.3)
WBC (1000 cells/cubic mm)- Week 24 Number Analyzed 812 participants 819 participants 805 participants 1624 participants
6.1
(5.1 to 7.3)
6.15
(5.03 to 7.43)
6.05
(5 to 7.43)
6.1
(5.01 to 7.43)
WBC (1000 cells/cubic mm)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
6.1
(4.96 to 7.33)
6.1
(5 to 7.4)
6.05
(5 to 7.4)
6.1
(5 to 7.4)
WBC (1000 cells/cubic mm)- Week 40 Number Analyzed 790 participants 786 participants 765 participants 1551 participants
6.09
(5 to 7.3)
6.09
(4.9 to 7.3)
5.95
(5 to 7.21)
6
(4.9 to 7.25)
WBC (1000 cells/cubic mm)- Week 48 Number Analyzed 772 participants 775 participants 753 participants 1528 participants
6.16
(5.1 to 7.41)
6
(5 to 7.21)
6
(5.03 to 7.14)
6
(5 to 7.18)
WBC (1000 cells/cubic mm)- Week 56 Number Analyzed 754 participants 763 participants 750 participants 1513 participants
6.1
(5.05 to 7.3)
6.04
(4.88 to 7.43)
5.9
(4.94 to 7.12)
6
(4.9 to 7.3)
WBC (1000 cells/cubic mm)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
6.05
(5.04 to 7.2)
5.9
(4.9 to 7.38)
5.95
(4.9 to 7.11)
5.94
(4.9 to 7.2)
WBC (1000 cells/cubic mm)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
5.91
(5 to 7.1)
5.92
(4.89 to 7.2)
6.05
(5 to 7.3)
6
(4.9 to 7.22)
Platelets (1000 cells/cubic mm)- Week 0 Number Analyzed 902 participants 898 participants 897 participants 1795 participants
248.5
(213 to 286)
248
(210 to 289)
249
(214 to 290)
248.1
(212 to 290)
Platelets (1000 cells/cubic mm)- Week 8 Number Analyzed 864 participants 853 participants 854 participants 1707 participants
248
(214.95 to 289)
250
(213 to 291)
248
(213 to 288)
249
(213 to 290)
Platelets (1000 cells/cubic mm)- Week 16 Number Analyzed 840 participants 834 participants 831 participants 1665 participants
249.5
(216 to 287)
252
(214 to 293)
251
(214 to 291)
251
(214 to 292)
Platelets (1000 cells/cubic mm)- Week 24 Number Analyzed 812 participants 817 participants 805 participants 1622 participants
251.5
(217 to 290.95)
250
(215 to 292)
251
(214 to 287)
250.5
(214 to 289)
Platelets (1000 cells/cubic mm)- Week 32 Number Analyzed 802 participants 796 participants 788 participants 1584 participants
252
(218 to 290)
253.5
(216 to 296)
250
(215 to 289)
252
(215.75 to 291)
Platelets (1000 cells/cubic mm)- Week 40 Number Analyzed 790 participants 786 participants 765 participants 1551 participants
250.7
(218 to 289)
254.5
(215.3 to 294)
250
(213 to 288)
252
(214 to 291)
Platelets (1000 cells/cubic mm)- Week 48 Number Analyzed 771 participants 775 participants 753 participants 1528 participants
251
(220 to 290)
256
(219 to 291)
251
(215 to 289)
253
(217 to 290.2)
Platelets (1000 cells/cubic mm)- Week 56 Number Analyzed 753 participants 763 participants 750 participants 1513 participants
254
(220 to 294)
256
(219 to 296)
251
(215 to 292)
253
(217 to 294)
Platelets (1000 cells/cubic mm)- Week 64 Number Analyzed 737 participants 747 participants 721 participants 1468 participants
254
(219 to 291)
256
(219 to 296)
249
(216 to 289)
252
(217 to 293)
Platelets (1000 cells/cubic mm)- Week 72 Number Analyzed 721 participants 731 participants 719 participants 1450 participants
254
(221 to 297)
253
(220 to 298)
253
(219 to 289)
253
(219 to 293)
9.Primary Outcome
Title Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hide Description The number (percentage) of participants with chemistry and hematology laboratory measures meeting grade 3 AE criteria or above as specified in the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017] is tabulated by treatment group and timepoint. Excludes measures taken prior to exposure to study product at Week 0/Infusion 1.
Time Frame Measured at Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Measure Type: Count of Participants
Unit of Measure: Participants
ALT (SGPT) (U/L)- Week 8 Number Analyzed 865 participants 855 participants 856 participants 1711 participants
1
   0.1%
0
   0.0%
1
   0.1%
1
   0.1%
ALT (SGPT) (U/L)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
1
   0.1%
0
   0.0%
4
   0.5%
4
   0.2%
ALT (SGPT) (U/L)- Week 24 Number Analyzed 811 participants 820 participants 805 participants 1625 participants
3
   0.4%
2
   0.2%
2
   0.2%
4
   0.2%
ALT (SGPT) (U/L)- Week 32 Number Analyzed 802 participants 797 participants 787 participants 1584 participants
2
   0.2%
1
   0.1%
1
   0.1%
2
   0.1%
ALT (SGPT) (U/L)- Week 40 Number Analyzed 790 participants 784 participants 765 participants 1549 participants
0
   0.0%
2
   0.3%
1
   0.1%
3
   0.2%
ALT (SGPT) (U/L)- Week 48 Number Analyzed 772 participants 776 participants 754 participants 1530 participants
4
   0.5%
0
   0.0%
1
   0.1%
1
   0.1%
ALT (SGPT) (U/L)- Week 56 Number Analyzed 754 participants 763 participants 749 participants 1512 participants
1
   0.1%
4
   0.5%
3
   0.4%
7
   0.5%
ALT (SGPT) (U/L)- Week 64 Number Analyzed 737 participants 748 participants 722 participants 1470 participants
3
   0.4%
2
   0.3%
1
   0.1%
3
   0.2%
ALT (SGPT) (U/L)- Week 72 Number Analyzed 721 participants 731 participants 718 participants 1449 participants
1
   0.1%
3
   0.4%
0
   0.0%
3
   0.2%
Hemoglobin (g/dL)- Week 8 Number Analyzed 865 participants 853 participants 855 participants 1708 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 24 Number Analyzed 812 participants 819 participants 805 participants 1624 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 40 Number Analyzed 790 participants 786 participants 765 participants 1551 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 48 Number Analyzed 772 participants 775 participants 753 participants 1528 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 56 Number Analyzed 754 participants 763 participants 750 participants 1513 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin (g/dL)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine (mg/dL)- Week 8 Number Analyzed 866 participants 855 participants 856 participants 1711 participants
7
   0.8%
1
   0.1%
2
   0.2%
3
   0.2%
Creatinine (mg/dL)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
3
   0.4%
3
   0.4%
3
   0.4%
6
   0.4%
Creatinine (mg/dL)- Week 24 Number Analyzed 812 participants 820 participants 805 participants 1625 participants
6
   0.7%
3
   0.4%
2
   0.2%
5
   0.3%
Creatinine (mg/dL)- Week 32 Number Analyzed 802 participants 797 participants 787 participants 1584 participants
4
   0.5%
3
   0.4%
5
   0.6%
8
   0.5%
Creatinine (mg/dL)- Week 40 Number Analyzed 791 participants 786 participants 765 participants 1551 participants
5
   0.6%
7
   0.9%
6
   0.8%
13
   0.8%
Creatinine (mg/dL)- Week 48 Number Analyzed 772 participants 776 participants 754 participants 1530 participants
3
   0.4%
3
   0.4%
1
   0.1%
4
   0.3%
Creatinine (mg/dL)- Week 56 Number Analyzed 754 participants 763 participants 750 participants 1513 participants
5
   0.7%
4
   0.5%
2
   0.3%
6
   0.4%
Creatinine (mg/dL)- Week 64 Number Analyzed 737 participants 748 participants 722 participants 1470 participants
3
   0.4%
5
   0.7%
2
   0.3%
7
   0.5%
Creatinine (mg/dL)- Week 72 Number Analyzed 722 participants 732 participants 718 participants 1450 participants
4
   0.6%
4
   0.5%
2
   0.3%
6
   0.4%
WBC (1000/cubic mm)- Week 8 Number Analyzed 865 participants 853 participants 855 participants 1708 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 16 Number Analyzed 841 participants 836 participants 832 participants 1668 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 24 Number Analyzed 812 participants 819 participants 805 participants 1624 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 40 Number Analyzed 790 participants 786 participants 765 participants 1551 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 48 Number Analyzed 772 participants 775 participants 753 participants 1528 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 56 Number Analyzed 754 participants 763 participants 750 participants 1513 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC (1000/cubic mm)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 8 Number Analyzed 864 participants 853 participants 854 participants 1707 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 16 Number Analyzed 840 participants 834 participants 831 participants 1665 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 24 Number Analyzed 812 participants 817 participants 805 participants 1622 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 32 Number Analyzed 802 participants 796 participants 788 participants 1584 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 40 Number Analyzed 790 participants 786 participants 765 participants 1551 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 48 Number Analyzed 771 participants 775 participants 753 participants 1528 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 56 Number Analyzed 753 participants 763 participants 750 participants 1513 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 64 Number Analyzed 737 participants 747 participants 721 participants 1468 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (1000/cubic mm)- Week 72 Number Analyzed 721 participants 731 participants 719 participants 1450 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 8 Number Analyzed 865 participants 851 participants 854 participants 1705 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 16 Number Analyzed 840 participants 836 participants 832 participants 1668 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 24 Number Analyzed 811 participants 819 participants 805 participants 1624 participants
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 40 Number Analyzed 789 participants 786 participants 765 participants 1551 participants
0
   0.0%
0
   0.0%
1
   0.1%
1
   0.1%
Lymphocytes (cells/cubic mm)- Week 48 Number Analyzed 772 participants 774 participants 752 participants 1526 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 56 Number Analyzed 754 participants 762 participants 750 participants 1512 participants
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes (cells/cubic mm)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils (cells/cubic mm)- Week 8 Number Analyzed 865 participants 851 participants 854 participants 1705 participants
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.1%
Neutrophils (cells/cubic mm)- Week 16 Number Analyzed 840 participants 836 participants 832 participants 1668 participants
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.1%
Neutrophils (cells/cubic mm)- Week 24 Number Analyzed 811 participants 819 participants 805 participants 1624 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils (cells/cubic mm)- Week 32 Number Analyzed 802 participants 797 participants 788 participants 1585 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils (cells/cubic mm)- Week 40 Number Analyzed 789 participants 786 participants 765 participants 1551 participants
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.1%
Neutrophils (cells/cubic mm)- Week 48 Number Analyzed 772 participants 774 participants 752 participants 1526 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils (cells/cubic mm)- Week 56 Number Analyzed 754 participants 762 participants 750 participants 1512 participants
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.1%
Neutrophils (cells/cubic mm)- Week 64 Number Analyzed 737 participants 748 participants 721 participants 1469 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils (cells/cubic mm)- Week 72 Number Analyzed 722 participants 731 participants 719 participants 1450 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Hide Description The number (percentage) of participants with early permanent discontinuation of infusions and their reason for discontinuation is summarized by treatment group. Includes all discontinuations documented on a study case report form.
Time Frame Measured through Week 72 (the last infusion visit).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description:
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897 1796
Measure Type: Count of Participants
Unit of Measure: Participants
Pregnancy
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HIV infection
37
   4.1%
32
   3.6%
21
   2.3%
53
   3.0%
Death
0
   0.0%
2
   0.2%
0
   0.0%
2
   0.1%
Clinical event other than reactogenicity
14
   1.6%
16
   1.8%
20
   2.2%
36
   2.0%
Reactogenicity Symptom
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Investigator Reason
7
   0.8%
2
   0.2%
1
   0.1%
3
   0.2%
Participant refused study product infusion
5
   0.6%
5
   0.6%
7
   0.8%
12
   0.7%
Co-enrollment in a study
1
   0.1%
2
   0.2%
1
   0.1%
3
   0.2%
Two(2) reactive HIV tests
0
   0.0%
0
   0.0%
3
   0.3%
3
   0.2%
Other
11
   1.2%
6
   0.7%
7
   0.8%
13
   0.7%
Termination from study for non-medical reason(s)
69
   7.6%
75
   8.3%
80
   8.9%
155
   8.6%
No Discontinuation
759
  84.1%
759
  84.4%
757
  84.4%
1516
  84.4%
11.Primary Outcome
Title Incidence Rate of Early Infusion Discontinuation
Hide Description Incidence rate (95% CI) of early infusion discontinuation per 100 person years. Includes discontinuations documented on a study case report form and operational discontinuations defined as 20 consecutive weeks without participant contact. Discontinuations due to pregnancy, death, or HIV-1 infection are right-censored.
Time Frame Measured through Week 72 (the last infusion visit).
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Safety population
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01
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Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 903 899 897
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 100 person years
8.9
(7.3 to 10.7)
10
(8.3 to 11.9)
8.8
(7.2 to 10.6)
12.Primary Outcome
Title Number of Participants With Documented HIV-1 Infection by the Week 80 Visit
Hide Description Prevention efficacy (PE) is measured as 1 minus the ratio (VRC01:control) of cumulative incidences of HIV-1 infection diagnosis between enrollment and the week 80 visit for assessment of the primary efficacy end point. Cumulative incidence was estimated with the Nelson-Aalen estimator for the cumulative hazard function, with stratification according to VRC01 dose and trial.
Time Frame Measured through Week 80.
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MITT population
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
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Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 898 895 894 1789
Measure Type: Count of Participants
Unit of Measure: Participants
38
   4.2%
32
   3.6%
28
   3.1%
60
   3.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled VRC01
Comments The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments The threshold for statistical significance was p = 0.05.
Method wald
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevention Efficacy (PE)
Estimated Value 26.6
Confidence Interval (2-Sided) 95%
-11.7 to 51.8
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo, Low-Dose VRC01
Comments A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevention Efficacy (PE)
Estimated Value 22.4
Confidence Interval (2-Sided) 95%
-25.5 to 52.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, High-Dose VRC01
Comments A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevention Efficacy (PE)
Estimated Value 30.9
Confidence Interval (2-Sided) 95%
-13.9 to 58.0
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
Hide Description The pharmacokinetic analyses of VRC01 involved a subgroup of VRC01 recipients who had not acquired HIV-1 infection through the week 88 visit and were not likely to have used preexposure prophylaxis (on the basis of self-report or testing of dried blood-spot samples), randomly sampled among the trials and dose groups. Midpoint and trough concentrations are the participant-level median concentrations at the 4-week and 8-week postinfusion visits, respectively, across all 10 infusion intervals.
Time Frame Day 61 (5 days post infusion #2), Midpoint (4-weeks post infusion visits): Weeks 4, 12, 16, 28, 36, 44, 52, 60, 68, 76 and Trough (infusion visits): Pre dose at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
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Pilot study population
Arm/Group Title Low-Dose VRC01 High-Dose VRC01
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VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: μg/ml
4-week post infusion visit
23.1
(8.8 to 43.9)
55.1
(26.6 to 89.5)
8-week post infusion visit
5.8
(1.5 to 18.3)
15.4
(4.5 to 29.8)
Day 61
65.7
(41.7 to 116.1)
212
(125.5 to 287.5)
14.Secondary Outcome
Title VRC01 Clinical Lot Neutralization of Founder Viruses (IC80)
Hide Description The VRC01 80% inhibitory concentration (IC80) of acquired isolates was measured with the TZM-bl assay using the earliest available post-HIV-infection serum sample. Median and IQR are summarized immediately below, then the analysis of prevention efficacy was repeated for each of three prespecified categories of in vitro susceptibility of the infecting strain (IC80 less than 1 μg per milliliter, 1 to 3 μg per milliliter, or >3 μg per milliliter) with the use of the Aalen-Johansen estimator.
Time Frame Measured through Week 80.
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MITT population
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
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Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 898 895 894 1789
Median (Inter-Quartile Range)
Unit of Measure: μg/ml
3.28
(0.79 to 8.58)
4.7
(2.39 to 19.43)
5.78
(2.3 to 12.56)
4.97
(2.34 to 15.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled VRC01
Comments PE against IC80 of least sensitive variant less than 1
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevention Efficacy (PE)
Estimated Value 73
Confidence Interval (2-Sided) 95%
27.6 to 89.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled VRC01
Comments PE against IC80 of least sensitive variant 1-3
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevention Efficacy (PE)
Estimated Value 6.1
Confidence Interval (2-Sided) 95%
-174.3 to 67.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Pooled VRC01
Comments PE against IC80 of least sensitive variant > 3
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevention Efficacy (PE)
Estimated Value 8.6
Confidence Interval (2-Sided) 95%
-68.1 to 50.3
Estimation Comments [Not Specified]
15.Secondary Outcome
Title VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80)
Hide Description Autologous titer (ID50, ID80) summaries, based on most sensitive virus, for first RNA+ samples from a subset of HIV-infected VRC01 recipients. Values below the limit of detection (less than 10) were set to NA. Summaries are only computed for the Pooled VRC01 arm.
Time Frame First RNA+ Sample detected from baseline up to Week 104.
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Subset of HIV-infected VRC01 recipients
Arm/Group Title Pooled VRC01
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VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Overall Number of Participants Analyzed 31
Median (Full Range)
Unit of Measure: titer
ID50
NA [1] 
(NA to 125.3)
ID80
NA [1] 
(NA to 34.18)
[1]
Values below the limit of detection (less than 10) were set to NA.
Time Frame The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Hide Arm/Group Description Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
All-Cause Mortality
Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/903 (0.22%)      3/899 (0.33%)      0/897 (0.00%)      3/1796 (0.17%)    
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Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/903 (3.54%)      35/899 (3.89%)      32/897 (3.57%)      67/1796 (3.73%)    
Cardiac disorders         
Any Event in SOC * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 3/897 (0.33%)  4 3/1796 (0.17%)  4
Angina unstable * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Atrial fibrillation * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Coronary artery occlusion * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Myocardial infarction * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Myocardial ischaemia * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Gastrointestinal disorders         
Any Event in SOC * 1  3/903 (0.33%)  6 0/899 (0.00%)  0 4/897 (0.45%)  5 4/1796 (0.22%)  5
Abdominal pain upper * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Diarrhoea * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Enterocolitis * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Gastrointestinal haemorrhage * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Gastrooesophageal reflux disease * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Incarcerated inguinal hernia * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Large intestine perforation * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Nausea * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Pancreatitis * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  2 1/1796 (0.06%)  2
Vomiting * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
General disorders         
Any Event in SOC * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Non-cardiac chest pain * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Hepatobiliary disorders         
Any Event in SOC * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Cholecystitis acute * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Cholecystitis chronic * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Infections and infestations         
Any Event in SOC * 1  10/903 (1.11%)  10 14/899 (1.56%)  15 10/897 (1.11%)  10 24/1796 (1.34%)  25
Abscess limb * 1  2/903 (0.22%)  2 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Anal abscess * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Appendicitis * 1  4/903 (0.44%)  4 5/899 (0.56%)  5 3/897 (0.33%)  3 8/1796 (0.45%)  8
COVID-19 * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Cellulitis * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Endocarditis * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Febrile infection * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Gastroenteritis salmonella * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Injection site cellulitis * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Lung abscess * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Oral herpes * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Pneumonia * 1  1/903 (0.11%)  1 2/899 (0.22%)  2 1/897 (0.11%)  1 3/1796 (0.17%)  3
Pneumonia bacterial * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Pyelonephritis * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Shigella infection * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Tuberculous pleurisy * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Varicella * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Injury, poisoning and procedural complications         
Any Event in SOC * 1  5/903 (0.55%)  8 7/899 (0.78%)  8 2/897 (0.22%)  2 9/1796 (0.50%)  10
Abdominal injury * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Alcohol poisoning * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Contusion * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Femur fracture * 1  1/903 (0.11%)  2 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Lower limb fracture * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Multiple fractures * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Multiple injuries * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Skin laceration * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Tendon rupture * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Thermal burn * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Tibia fracture * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Toxicity to various agents * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Ulna fracture * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Upper limb fracture * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Investigations         
Any Event in SOC * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Platelet count decreased * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Metabolism and nutrition disorders         
Any Event in SOC * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Hypernatraemia * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Hyponatraemia * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Any Event in SOC * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Osteopenia * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Any Event in SOC * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Anogenital warts * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Colon cancer metastatic * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Nervous system disorders         
Any Event in SOC * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Radial nerve palsy * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Syncope * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Psychiatric disorders         
Any Event in SOC * 1  10/903 (1.11%)  18 8/899 (0.89%)  10 12/897 (1.34%)  15 20/1796 (1.11%)  25
Alcoholism * 1  2/903 (0.22%)  3 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Anxiety * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Bipolar I disorder * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Bipolar disorder * 1  1/903 (0.11%)  1 2/899 (0.22%)  3 3/897 (0.33%)  4 5/1796 (0.28%)  7
Completed suicide * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Depression * 1  1/903 (0.11%)  2 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Emotional distress * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Hallucination, auditory * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Major depression * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Mania * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 2/897 (0.22%)  2 2/1796 (0.11%)  2
Psychotic disorder * 1  2/903 (0.22%)  3 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Substance dependence * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Substance-induced psychotic disorder * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Suicidal ideation * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 4/897 (0.45%)  4 5/1796 (0.28%)  5
Suicide attempt * 1  4/903 (0.44%)  6 2/899 (0.22%)  2 2/897 (0.22%)  2 4/1796 (0.22%)  4
Renal and urinary disorders         
Any Event in SOC * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Nephrolithiasis * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Respiratory, thoracic and mediastinal disorders         
Any Event in SOC * 1  0/903 (0.00%)  0 2/899 (0.22%)  2 1/897 (0.11%)  1 3/1796 (0.17%)  3
Pneumomediastinum * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Pneumonia aspiration * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Pneumothorax spontaneous * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
1
Term from vocabulary, MedDRA 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Low-Dose VRC01 High-Dose VRC01 Pooled VRC01
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   750/903 (83.06%)      771/899 (85.76%)      742/897 (82.72%)      1513/1796 (84.24%)    
Blood and lymphatic system disorders         
Any Event in SOC * 1  17/903 (1.88%)  18 26/899 (2.89%)  28 23/897 (2.56%)  29 49/1796 (2.73%)  57
Anaemia * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Iron deficiency anaemia * 1  2/903 (0.22%)  2 3/899 (0.33%)  3 0/897 (0.00%)  0 3/1796 (0.17%)  3
Leukopenia * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Lymphadenitis * 1  2/903 (0.22%)  2 0/899 (0.00%)  0 2/897 (0.22%)  3 2/1796 (0.11%)  3
Lymphadenopathy * 1  11/903 (1.22%)  12 15/899 (1.67%)  16 14/897 (1.56%)  17 29/1796 (1.61%)  33
Lymphopenia * 1  2/903 (0.22%)  2 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Microcytic anaemia * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Microcytosis * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Neutropenia * 1  0/903 (0.00%)  0 3/899 (0.33%)  3 5/897 (0.56%)  6 8/1796 (0.45%)  9
Splenomegaly * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Thrombocytopenia * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Cardiac disorders         
Any Event in SOC * 1  7/903 (0.78%)  8 3/899 (0.33%)  3 3/897 (0.33%)  3 6/1796 (0.33%)  6
Atrioventricular block second degree * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Brugada syndrome * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Intracardiac mass * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Palpitations * 1  3/903 (0.33%)  3 2/899 (0.22%)  2 2/897 (0.22%)  2 4/1796 (0.22%)  4
Postural orthostatic tachycardia syndrome * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Sinus tachycardia * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Tachycardia * 1  2/903 (0.22%)  2 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Congenital, familial and genetic disorders         
Any Event in SOC * 1  2/903 (0.22%)  2 2/899 (0.22%)  2 1/897 (0.11%)  1 3/1796 (0.17%)  3
Dermoid cyst * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Encephalocele * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Frenulum breve * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Hypertrophic cardiomyopathy * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Tourette's disorder * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Ear and labyrinth disorders         
Any Event in SOC * 1  12/903 (1.33%)  12 17/899 (1.89%)  19 5/897 (0.56%)  5 22/1796 (1.22%)  24
Cerumen impaction * 1  0/903 (0.00%)  0 2/899 (0.22%)  2 1/897 (0.11%)  1 3/1796 (0.17%)  3
Deafness unilateral * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Ear discomfort * 1  2/903 (0.22%)  2 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Ear pain * 1  2/903 (0.22%)  2 7/899 (0.78%)  7 1/897 (0.11%)  1 8/1796 (0.45%)  8
Ear pruritus * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Motion sickness * 1  0/903 (0.00%)  0 2/899 (0.22%)  2 0/897 (0.00%)  0 2/1796 (0.11%)  2
Tinnitus * 1  1/903 (0.11%)  1 2/899 (0.22%)  2 0/897 (0.00%)  0 2/1796 (0.11%)  2
Tympanic membrane hyperaemia * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Tympanic membrane perforation * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Vertigo * 1  5/903 (0.55%)  5 2/899 (0.22%)  2 1/897 (0.11%)  1 3/1796 (0.17%)  3
Vertigo positional * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Endocrine disorders         
Any Event in SOC * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Hypothyroidism * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Eye disorders         
Any Event in SOC * 1  14/903 (1.55%)  14 11/899 (1.22%)  12 8/897 (0.89%)  8 19/1796 (1.06%)  20
Blepharitis * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Blepharospasm * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Cataract * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Chalazion * 1  2/903 (0.22%)  2 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Conjunctival haemorrhage * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Conjunctival hyperaemia * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Conjunctivitis allergic * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Diplopia * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Dry eye * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Erythema of eyelid * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Eye inflammation * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Eye irritation * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Eye pain * 1  2/903 (0.22%)  2 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Eye pruritus * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Eye swelling * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 1/897 (0.11%)  1 2/1796 (0.11%)  2
Keratitis * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Keratoconus * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Lacrimation increased * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Lagophthalmos * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Macular degeneration * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Ocular hyperaemia * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Retinal detachment * 1  1/903 (0.11%)  1 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Scintillating scotoma * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Strabismus * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Swelling of eyelid * 1  1/903 (0.11%)  1 0/899 (0.00%)  0 0/897 (0.00%)  0 0/1796 (0.00%)  0
Vision blurred * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Gastrointestinal disorders         
Any Event in SOC * 1  155/903 (17.17%)  211 183/899 (20.36%)  269 175/897 (19.51%)  253 358/1796 (19.93%)  522
Abdominal discomfort * 1  4/903 (0.44%)  4 1/899 (0.11%)  1 7/897 (0.78%)  7 8/1796 (0.45%)  8
Abdominal distension * 1  2/903 (0.22%)  2 3/899 (0.33%)  3 0/897 (0.00%)  0 3/1796 (0.17%)  3
Abdominal hernia * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Abdominal pain * 1  8/903 (0.89%)  9 8/899 (0.89%)  8 11/897 (1.23%)  11 19/1796 (1.06%)  19
Abdominal pain lower * 1  1/903 (0.11%)  1 2/899 (0.22%)  2 1/897 (0.11%)  1 3/1796 (0.17%)  3
Abdominal pain upper * 1  3/903 (0.33%)  3 5/899 (0.56%)  5 4/897 (0.45%)  4 9/1796 (0.50%)  9
Acquired oesophageal web * 1  0/903 (0.00%)  0 1/899 (0.11%)  1 0/897 (0.00%)  0 1/1796 (0.06%)  1
Anal fissure * 1  4/903 (0.44%)  5 10/899 (1.11%)  12 8/897 (0.89%)  8 18/1796 (1.00%)  20
Anal fistula * 1  1/903 (0.11%)  1 2/899 (0.22%)  2 2/897 (0.22%)  2 4/1796 (0.22%)  4
Anal haemorrhage * 1  0/903 (0.00%)  0 0/899 (0.00%)  0 1/897 (0.11%)  1 1/1796 (0.06%)  1
Anal pruritus * 1  8/903 (0.89%)