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Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV

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ClinicalTrials.gov Identifier: NCT00659789
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : January 5, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Bionor Immuno AS

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV I Infection
Interventions Drug: Vacc-4x
Drug: Sterile water
Enrollment 137
Recruitment Details The first subject was screened on 29 July 2008 and the first immunization was given on 22 August 2008. The last subject completed the study (to Week 52) on 22 June 2010. The last long-term follow-up visit was 07 June 2011.
Pre-assignment Details 137 study participants were enrolled. One participant withdrew prior to randomization.
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART
Hide Arm/Group Description Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18. Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Period Title: Overall Study
Started 93 43
Completed 86 36
Not Completed 7 7
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART Total
Hide Arm/Group Description Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18. Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18. Total of all reporting groups
Overall Number of Baseline Participants 92 43 135
Hide Baseline Analysis Population Description
ITT population
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age, Categorial Number Analyzed 92 participants 43 participants 135 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 15 and 55
92
 100.0%
43
 100.0%
135
 100.0%
>=55 years
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 43 participants 135 participants
Female
14
  15.2%
5
  11.6%
19
  14.1%
Male
78
  84.8%
38
  88.4%
116
  85.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 43 participants 135 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.3%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   4.3%
5
  11.6%
9
   6.7%
White
88
  95.7%
37
  86.0%
125
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Height  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 92 participants 43 participants 135 participants
175
(155 to 190)
175
(159 to 200)
175
(155 to 200)
Time since HIV diagnosis (days)  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 92 participants 43 participants 135 participants
3861
(466 to 8794)
4480
(814 to 8990)
4309
(466 to 8990)
CD4 nadir  
Median (Full Range)
Unit of measure:  10^6 cells/L
Number Analyzed 92 participants 43 participants 135 participants
300
(200 to 734)
285
(200 to 724)
298
(200 to 734)
Pre-ART CD4  
Median (Full Range)
Unit of measure:  10^6 cells/L
Number Analyzed 92 participants 43 participants 135 participants
339
(177 to 1396)
370
(207 to 924)
357
(177 to 1396)
Pre-ART HIV-1 viral load  
Median (Full Range)
Unit of measure:  copies/mL
Number Analyzed 92 participants 43 participants 135 participants
94810
(120 to 2500000)
25630
(412 to 1460000)
75398
(120 to 2500000)
Total time on ART  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 92 participants 43 participants 135 participants
95.5
(13 to 276)
112
(13 to 197)
108
(13 to 276)
1.Primary Outcome
Title Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Hide Description [Not Specified]
Time Frame From Week 28 to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART.
Hide Arm/Group Description:
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Overall Number of Participants Analyzed 92 43
Measure Type: Number
Unit of Measure: participants
Number of subjects attending Week 28 visit 88 40
Subjects coming off ART at Week 28 88 38
Subjects not qualifying for ART interruption 0 1
Subjects resuming ART between week 28 and 52 30 11
Subjects restarting ART at Week 52/termination 12 7
2.Secondary Outcome
Title Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
Hide Description Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.
Time Frame Up to week 52
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Hide Analysis Population Description
Safety Population
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART.
Hide Arm/Group Description:
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Overall Number of Participants Analyzed 93 42
Measure Type: Number
Unit of Measure: participants
Any TEAE up to week 52/early termination 91 40
TEAE - Mild 27 13
TEAE - Moderate 54 21
TEAE - Severe 9 6
TEAE - Life threatening 1 0
Related TEAE up to week 52/early termination 81 24
Related TEAE - Mild 40 19
Related TEAE - Moderate 37 5
Related TEAE - Severe 4 0
Related TEAE - Life threatening 0 0
Any TESAE up to week 52/early termination 4 3
Any related TESAE up to week 52/early termination 1 0
Any TEAE leading to treatment discontinuation 2 0
Treatment-related TEAE leading to discontinuation 2 0
Deaths 0 1
3.Secondary Outcome
Title Immunogenicity
Hide Description Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema
Time Frame Week 1, week 18 and week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART.
Hide Arm/Group Description:
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Overall Number of Participants Analyzed 92 43
Measure Type: Number
Unit of Measure: participants
Induration week 1 (Vacc-4x n=92; placebo n=43 3 1
Induration week 18 (Vacc-4x n=88; placebo n=41) 27 0
Induration week 52 (Vacc-4x n=78; placebo n=36) 26 0
Induration week 52(LOCF) Vacc-4x n=92;placebo n=43 30 0
Erythema week 1 (Vacc-4x n=92;placebo n=43) 3 1
Erythema week 18 (Vacc-4x n=88; placebo n=41) 40 0
Erythema week 52 (Vacc-4x n=78;placebo n=36) 34 0
Erythema week 52 (LOCF) Vacc-4x n=92;placebo n=43 40 0
4.Secondary Outcome
Title Effect of Vacc-4x on CD8 Counts
Hide Description CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52
Time Frame Weeks 6,18,24,28,32,36,40,44,48,52.
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Hide Analysis Population Description
Subject who stopped ART at week 28 and remained off ART until week 52
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART.
Hide Arm/Group Description:
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Overall Number of Participants Analyzed 56 25
Median (Inter-Quartile Range)
Unit of Measure: cells/µL
week 6 (Vacc-4x n=54;placebo n=25)
786.0
(636.0 to 934.0)
865.0
(544.0 to 1123.0)
week 18 (Vacc-4x n=56; placebo n=25)
853.5
(686.5 to 1055.0)
897.0
(604.0 to 1176.0)
week 24 (Vacc-4x n=56; placebo n=25)
804.0
(583.0 to 1111.5)
771.0
(592.0 to 1040.0)
week 28 (Vacc-4x n=56; placebo n=25)
820.5
(670.5 to 1050.5)
879.0
(570.0 to 1111.0)
week 32 (Vacc-4x n=56; placebo n=25)
962.0
(694.5 to 1352.5)
1161.0
(789.0 to 1456.0)
week 36 (Vacc-4x n=56; placebo n=25)
1385.5
(953.0 to 1748.5)
1416.0
(1006.0 to 2058.0)
week 40 (Vacc-4x n=54; placebo n=25)
1252.5
(849.0 to 1788.0)
1253.0
(866.0 to 1592.0)
week 44 (Vacc-4x n=56; placebo n=25)
1156.0
(799.0 to 1665.0)
1106.0
(851.0 to 1545.0)
week 48 (Vacc-4x n=55; placebo n=24)
1118.0
(857.0 to 1641.0)
1217.0
(827.0 to 1463.5)
week 52 (completers) (Vacc-4x n=56;placebo n=25)
1064.0
(725.0 to 1368.5)
1047.0
(747.0 to 1502.0)
5.Secondary Outcome
Title Time to Restart of ART for Vacc-4x Subjects Versus Placebo
Hide Description Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)
Time Frame Between Week 28 to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART.
Hide Arm/Group Description:
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Overall Number of Participants Analyzed 88 40
Mean (Standard Deviation)
Unit of Measure: days
141.8  (47.40) 133.5  (57.27)
6.Secondary Outcome
Title Effects on Vacc-4x on HIV-1 RNA
Hide Description [Not Specified]
Time Frame Weeks 24,28,32,36,40,44,48,52.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART.
Hide Arm/Group Description:
Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Overall Number of Participants Analyzed 92 43
Mean (Standard Deviation)
Unit of Measure: copies/mL
week 24 (Vacc-4x n=90; placebo n=41) 629.6  (5807.26) 9.2  (22.85)
week 28 (Vacc-4x n=89; placebo n=40) 1351.4  (5710.99) 1628.5  (10131.81)
week 32 (Vacc-4x n=88; placebo n=38) 192115.0  (361003.40) 205605.2  (383020.31)
week 36 (Vacc-4x n=81; placebo n=35) 89134.8  (165945.62) 89211.9  (97983.28)
week 40 (Vacc-4x n=71; placebo n=32) 72705.0  (143582.93) 76127.8  (81891.91)
week 44 (Vacc-4x n=63; placebo n=27) 44969.7  (65798.22) 66203.3  (72099.23)
week 48 (Vacc-4x n=59; placebo n=25) 48848.2  (90232.17) 77219.4  (70851.98)
week 52 (Vacc-4x n=56; placebo n=24) 35219.6  (42181.85) 67684.0  (67869.61)
Time Frame Adverse events (AEs) recorded from Screening to Week 52
Adverse Event Reporting Description Safety data was based on 93 Vacc-4x participants and 42 placebo participants because one placebo participant received an injection with Vacc-4x in error.
 
Arm/Group Title Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART
Hide Arm/Group Description Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18. Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
All-Cause Mortality
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/93 (4.30%)      3/42 (7.14%)    
Gastrointestinal disorders     
Appendicitis perforated  1 [1]  1/93 (1.08%)  1 0/42 (0.00%)  0
General disorders     
Necrosis  1 [2]  0/93 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations     
Cellulitis of male external genital organ  1 [3]  1/93 (1.08%)  1 0/42 (0.00%)  0
Appendicitis  1 [4]  1/93 (1.08%)  1 0/42 (0.00%)  0
Postoperative wound infection  1 [5]  1/93 (1.08%)  1 0/42 (0.00%)  0
Injury, poisoning and procedural complications     
Procedural dizziness  1 [6]  0/93 (0.00%)  0 1/42 (2.38%)  1
Nervous system disorders     
Multiple sclerosis  1 [7]  1/93 (1.08%)  1 0/42 (0.00%)  0
Psychiatric disorders     
Bipolar disorder  1 [8]  0/93 (0.00%)  0 1/42 (2.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
[1]
Perforated appendix
[2]
Atypic(al) necrosis of both femoral heads
[3]
Cellulitis of scrotum and penis
[4]
Acute appendicitis resulting in appendectomy
[5]
Surgical wound infection
[6]
Prolonged anesthesia effects (dizziness)
[7]
Multiple sclerosis
[8]
Bipolar disorder resulting in hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Placebo Injections (Group II) While on ART
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/93 (97.85%)      40/42 (95.24%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  2/93 (2.15%)  1/42 (2.38%) 
Gastrointestinal disorders     
Nausea  1  4/93 (4.30%)  2/42 (4.76%) 
Diarrhoea  1  2/93 (2.15%)  1/42 (2.38%) 
Abdominal pain  1  1/93 (1.08%)  0/42 (0.00%) 
General disorders     
Injection site erythema  1 [1]  62/93 (66.67%)  6/42 (14.29%) 
Injection site induration  1  39/93 (41.94%)  6/42 (14.29%) 
Injection site pruritus  1  35/93 (37.63%)  0/42 (0.00%) 
Fatigue  1  11/93 (11.83%)  5/42 (11.90%) 
Injection site pain  1  16/93 (17.20%)  6/42 (14.29%) 
Pyrexia  1  7/93 (7.53%)  1/42 (2.38%) 
Injection site swelling  1  15/93 (16.13%)  3/42 (7.14%) 
Influenza-like illness  1  3/93 (3.23%)  1/42 (2.38%) 
Asthenia  1  4/93 (4.30%)  0/42 (0.00%) 
Chills  1  4/93 (4.30%)  0/42 (0.00%) 
Malaise  1  1/93 (1.08%)  1/42 (2.38%) 
Infections and infestations     
Nasopharyngitis  1  5/93 (5.38%)  0/42 (0.00%) 
Investigations     
ALT increased  1  0/93 (0.00%)  1/42 (2.38%) 
AST increased  1  0/93 (0.00%)  1/42 (2.38%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  6/93 (6.45%)  1/42 (2.38%) 
Arthralgia  1  1/93 (1.08%)  1/42 (2.38%) 
Musculoskeletal pain  1  1/93 (1.08%)  1/42 (2.38%) 
Nervous system disorders     
Headache  1  7/93 (7.53%)  3/42 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/93 (1.08%)  0/42 (0.00%) 
Oropharyngeal pain  1  1/93 (1.08%)  0/42 (0.00%) 
Skin and subcutaneous tissue disorders     
Eczema  1  1/93 (1.08%)  0/42 (0.00%) 
Night sweats  1  3/93 (3.23%)  1/42 (2.38%) 
Vascular disorders     
Hypertension  1  1/93 (1.08%)  0/42 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
[1]
Injection site erythema
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor (or designee) will prepare a final report on the study. The Investigator may not publish or present any information on this study without the express written approval of the Sponsor. Additionally, the Sponsor, may, for any reason, withhold approval for publication or presentation.
Results Point of Contact
Name/Title: Maja Sommerfelt
Organization: Bionor Pharma ASA
Phone: +4723010960
Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT00659789     History of Changes
Other Study ID Numbers: CT-BI Vacc-4x 2007/1
2007-006302-13 ( EudraCT Number )
13619 ( Other Identifier: FDA IND )
First Submitted: April 14, 2008
First Posted: April 16, 2008
Results First Submitted: July 22, 2015
Results First Posted: January 5, 2017
Last Update Posted: February 23, 2017