Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1927 for:    Sexually Transmitted Diseases | NIH
Previous Study | Return to List | Next Study

Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

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: NCT00604175
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : October 17, 2013
Last Update Posted : September 7, 2015
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Infections
Sexually Transmitted Diseases
Intervention Biological: Quadrivalent HPV vaccine
Enrollment 319
Recruitment Details 319 HIV-infected women 13-45 years of age were recruited in US, South Africa and Brazil between March 2008 and July 2011 for participation in this study.
Pre-assignment Details

Participants were enrolled into 3 strata based on screening CD4 cell count:

  • Stratum A: CD4 cell count >350 cells/mm^3
  • Stratum B: CD4 cell count >200 to <=350 cells/mm^3
  • Stratum C: CD4 cell count <=200 cells/mm^3
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Period Title: Entry Through Week 28
Started 130 95 94
Completed 120 [1] 92 [1] 93 [1]
Not Completed 10 3 1
Reason Not Completed
Death             2             0             0
Withdrawal by Subject             1             0             0
Lost to Follow-up             4             3             0
Ineligible             1             0             0
Did not start intervention             2             0             1
[1]
Completed 28 weeks of the study (the primary endpoint time point).
Period Title: Week 29 Through Week 72
Started 120 92 93
Completed 108 85 89
Not Completed 12 7 4
Reason Not Completed
Death             0             0             1
Lost to Follow-up             12             6             2
Site closure             0             1             0
Non-adherence to study requirements             0             0             1
Arm/Group Title Stratum A Stratum B Stratum C Total
Hide Arm/Group Description Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. Total of all reporting groups
Overall Number of Baseline Participants 127 95 93 315
Hide Baseline Analysis Population Description
All participants, except 4: one was found to be ineligible after enrollment (Stratum A) and 3 failed to start intervention (2 in Stratum A, 1 in Stratum C).
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 127 participants 95 participants 93 participants 315 participants
35
(29 to 40)
38
(33 to 42)
36
(31 to 40)
36
(30 to 41)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
13 - 17 years 0 0 1 1
18 - 24 years 10 3 7 20
25 - 29 years 24 11 12 47
30 - 34 years 26 14 20 60
35 - 39 years 31 26 24 81
40 - 45 years 36 41 29 106
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
Female
127
 100.0%
95
 100.0%
93
 100.0%
315
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
White, Non-Hispanic 19 9 8 36
Black, Non-Hispanic 67 59 51 177
Hispanic (Regardless of Race) 39 25 32 96
Asian, Pacific Islander 2 0 1 3
Unknown 0 2 1 3
[1]
Measure Description: Race/ethnicity, self-reported (NIH categories).
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
United States 113 80 69 262
Brazil 11 6 11 28
South Africa 3 9 13 25
HIV Antiretroviral Therapy (ART) Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
On ART 58 71 80 209
Not on ART 69 24 13 106
CD4 Cell Count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 127 participants 95 participants 93 participants 315 participants
519
(418 to 664)
287
(246 to 344)
154
(86 to 188)
310
(197 to 498)
Nadir CD4 Cell Count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 127 participants 95 participants 93 participants 315 participants
368
(234 to 482)
176
(64 to 261)
41
(20 to 108)
179
(47 to 314)
HIV Viral Load   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
<=10,000 copies/mL 71 69 61 201
>10,000 copies/mL 56 25 32 113
Unknown 0 1 0 1
[1]
Measure Description: A blood sample was drawn for HIV viral load testing by local laboratories. The assays used were Roche Amplicor Monitor HIV RT PCR, Roche UltraSensitive HIV RT PCR, bDNA (Versant HIV-1 RNA 3.0, 3rd), Roche COBAS AmpliPrep/Taqman HIV and Abbott RealTime HIV-1.
Human Papillomavirus Type 6 (HPV6) Serostatus   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
Seronegative 66 60 56 182
Seropositive 54 35 37 126
Unknown 7 0 0 7
[1]
Measure Description: HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV6 antibody titers <20 mMU/mL and seropositive as HPV6 antibody titers >=20 mMU/mL.
Human Papillomavirus Type 11 (HPV11) Serostatus   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
Seronegative 99 72 74 245
Seropositive 22 23 19 64
Unknown 6 0 0 6
[1]
Measure Description: HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV11 antibody titers <16 mMU/mL and seropositive as HPV11 antibody titers >=16 mMU/mL.
Human Papillomavirus Type 16 (HPV16) Serostatus   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
Seronegative 77 65 67 209
Seropositive 44 30 26 100
Unknown 6 0 0 6
[1]
Measure Description: HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV16 antibody titers <20 mMU/mL and seropositive as HPV16 antibody titers >=20 mMU/mL.
Human Papillomavirus Type 18 (HPV18) Serostatus   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 95 participants 93 participants 315 participants
Seronegative 92 83 73 248
Seropositive 29 12 20 61
Unknown 6 0 0 6
[1]
Measure Description: HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. Seronegative status was defined as HPV18 antibody titers <24 mMU/mL and seropositive as HPV18 antibody titers >=24 mMU/mL.
1.Primary Outcome
Title Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series
Hide Description Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis including all participants seronegative to HPV6 at baseline who completed the vaccination series per protocol and had HPV6 titer available at Week 28.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 54 50 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.3
(87.3 to 99.5)
100.0
(92.9 to 100.0)
84.4
(70.5 to 93.5)
2.Primary Outcome
Title Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series
Hide Description Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis including all participants seronegative to HPV11 at baseline who completed the vaccination series per protocol and had HPV11 titer available at Week 28.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 86 59 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.7
(91.9 to 99.7)
98.3
(90.9 to 100.0)
91.9
(82.2 to 97.3)
3.Primary Outcome
Title Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series
Hide Description Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis including all participants seronegative to HPV16 at baseline who completed the vaccination series per protocol and had HPV16 titer available at Week 28.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 67 56 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
98.5
(92.0 to 100.0)
98.2
(90.4 to 100.0)
92.9
(82.7 to 98.0)
4.Primary Outcome
Title Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series
Hide Description Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis including all participants seronegative to HPV18 at baseline who completed the vaccination series per protocol and had HPV18 titer available at Week 28.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 78 71 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
91.0
(82.4 to 96.3)
84.5
(74.0 to 92.0)
75.4
(62.7 to 85.5)
5.Secondary Outcome
Title HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline
Hide Description HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline.
Time Frame Weeks 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seronegative for HPV6 (HPV6-) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=60; 58; 52. Week 72: n=55; 53; 53.
Arm/Group Title Stratum A/Baseline HPV6- Stratum B/Baseline HPV6- Stratum C/Baseline HPV6-
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV6 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV6 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV6 at baseline.
Overall Number of Participants Analyzed 66 60 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
HPV6 titers at Week 28 (n=60; 58; 52)
462.3
(320.5 to 666.8)
349.2
(242.1 to 503.8)
137.1
(82.0 to 229.1)
HPV6 titers at Week 72 (n=55; 53; 53)
112.8
(81.5 to 155.9)
79.9
(52.1 to 122.6)
43.0
(29.0 to 63.7)
6.Secondary Outcome
Title HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline
Hide Description HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline.
Time Frame Weeks 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seronegative for HPV11 (HPV11-) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=93; 70; 71. Week 72: n=83; 66; 69.
Arm/Group Title Stratum A/Baseline HPV11- Stratum B/Baseline HPV11- Stratum C/Baseline HPV11-
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV11 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV11 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV11 at baseline.
Overall Number of Participants Analyzed 99 72 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
HPV11 at Week 28 (n=93; 70; 71)
476.5
(361.8 to 627.5)
417.2
(286.8 to 606.8)
205.1
(128.7 to 326.9)
HPV11 at Week 72 (n=83; 66; 69)
122.3
(90.1 to 166.0)
85.1
(56.0 to 129.3)
52.9
(35.0 to 79.9)
7.Secondary Outcome
Title HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline
Hide Description HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline.
Time Frame Weeks 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seronegative for HPV16 (HPV16-) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=73; 63; 64. Week 72: n=63; 59; 64.
Arm/Group Title Stratum A/Baseline HPV16- Stratum B/Baseline HPV16- Stratum C/Baseline HPV16-
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV16 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV16 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV16 at baseline.
Overall Number of Participants Analyzed 77 65 67
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
HPV16 at Week 28 (n=73; 63; 64)
1199.9
(870.5 to 1654.1)
1117.1
(746.2 to 1672.4)
570.8
(327.7 to 994.3)
HPV16 at Week 72 (n=63; 59; 64)
248.9
(171.3 to 361.6)
170.4
(106.8 to 271.8)
98.3
(61.9 to 156.1)
8.Secondary Outcome
Title HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline
Hide Description HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline.
Time Frame Weeks 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seronegative for HPV18 (HPV18-) at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=86; 80; 69. Week 72: n=75; 73; 69.
Arm/Group Title Stratum A/Baseline HPV18- Stratum B/Baseline HPV18- Stratum C/Baseline HPV18-
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV18 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV18 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV18 at baseline.
Overall Number of Participants Analyzed 92 83 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
HPV18 at Week 28 (n=86; 80; 69)
175.0
(126.2 to 242.6)
170.8
(114.5 to 254.7)
93.6
(58.6 to 149.4)
HPV18 at Week 72 (n=75; 73; 69)
41.9
(29.5 to 59.0)
40.6
(27.0 to 61.2)
20.8
(14.5 to 30.0)
9.Secondary Outcome
Title Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline
Hide Description Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6).
Time Frame Weeks 0, 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seropositive for HPV6 (HPV6+) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=52; n=33; n=36. Week 72: n=43; 31; 35.
Arm/Group Title Stratum A/Baseline HPV6+ Stratum B/Baseline HPV6+ Stratum C/Baseline HPV6+
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV6 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV6 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV6 at baseline.
Overall Number of Participants Analyzed 54 35 37
Median (Inter-Quartile Range)
Unit of Measure: Log10 mMU/mL
Change in HPV6 at Week 28 (n=52; 33; 36)
1.12
(0.59 to 1.54)
1.10
(0.61 to 1.52)
0.97
(0.55 to 1.29)
Change in HPV6 at Week 72 (n=43; 31; 35)
0.73
(0.33 to 1.14)
0.70
(0.41 to 1.00)
0.44
(0.08 to 0.82)
10.Secondary Outcome
Title Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline
Hide Description Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11).
Time Frame Weeks 0, 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seropositive for HPV11 (HPV11+) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=20; 21; 17. Week 72: n=17; 18; 19.
Arm/Group Title Stratum A/Baseline HPV11+ Stratum B/Baseline HPV11+ Stratum C/Baseline HPV11+
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV11 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV11 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV11 at baseline.
Overall Number of Participants Analyzed 22 23 19
Median (Inter-Quartile Range)
Unit of Measure: Log10 mMU/mL
Change in HPV11 at Week 28 (n=20; 21; 17)
1.32
(1.07 to 1.71)
1.42
(0.86 to 1.59)
0.60
(0.28 to 1.25)
Change in HPV11 at Week 72 (n=17; 18; 19)
0.93
(0.66 to 1.29)
0.89
(0.64 to 1.14)
0.43
(0.01 to 0.79)
11.Secondary Outcome
Title Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline
Hide Description Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16).
Time Frame Weeks 0, 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seropositive for HPV16 (HPV16+) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=40; 28; 24. Week 72: n=37; 25; 24.
Arm/Group Title Stratum A/Baseline HPV16+ Stratum B/Baseline HPV16+ Stratum C/Baseline HPV16+
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV16 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV16 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV16 at baseline.
Overall Number of Participants Analyzed 44 30 26
Median (Inter-Quartile Range)
Unit of Measure: Log10 mMU/mL
Change in HPV16 at Week 28 (n=40; 28; 24)
1.65
(1.26 to 1.93)
1.29
(0.84 to 1.86)
1.06
(0.62 to 1.79)
Change in HPV16 at Week 72 (n=37; 25; 24)
1.28
(0.79 to 1.68)
0.97
(0.56 to 1.59)
0.53
(0.17 to 1.04)
12.Secondary Outcome
Title Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline
Hide Description Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18).
Time Frame Weeks 0, 28, 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine and were seropositive for HPV18 at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=27; 11; 19. Week 72: n=25; 11; 19.
Arm/Group Title Stratum A/Baseline HPV18+ Stratum B/Baseline HPV18+ Stratum C/Baseline HPV18+
Hide Arm/Group Description:
Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV18 at baseline.
Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV18 at baseline.
Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV18 at baseline.
Overall Number of Participants Analyzed 29 12 20
Median (Inter-Quartile Range)
Unit of Measure: Log10 mMU/mL
Change in HPV18 at Week 28 (n=27; 11; 19)
1.02
(0.48 to 1.51)
0.89
(0.50 to 1.53)
0.85
(0.04 to 1.22)
Change in HPV18 at Week 72 (n=25; 11; 19)
0.57
(0.17 to 0.85)
0.20
(-0.08 to 0.96)
0.14
(0.02 to 0.61)
13.Secondary Outcome
Title Number of Participants With Signs and Symptoms of Grade 3 or Higher
Hide Description Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Time Frame From baseline to up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 127 95 93
Measure Type: Number
Unit of Measure: Participants
20 20 16
14.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities of Grade 3 or Higher
Hide Description Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Time Frame From baseline to up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who received at least one vaccine.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 127 95 93
Measure Type: Number
Unit of Measure: Participants
10 7 12
15.Secondary Outcome
Title Change in Log10 HIV Viral Load (VL) From Baseline
Hide Description A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline.
Time Frame Weeks 0, 4, 12, 28, 52, and 72
Hide Outcome Measure Data
Hide Analysis Population Description
N=315 eligible participants who initiated intervention and had HIV VL available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=123; 89; 88. Week 12: n=118; 89; 90. Week 28: n=118; 91; 87. Week 52: n=109; 85; 82. Week 72: n=105; 81; 83.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 127 95 93
Median (Inter-Quartile Range)
Unit of Measure: Log10 copies/mL
Change in log10 HIV VL at Week 4 (n=123; 89; 88)
0
(-0.18 to 0)
0
(-0.06 to 0.11)
0
(-0.15 to 0.01)
Change in log10 HIV VL at Week 12 (n=118; 89; 90)
0
(-0.27 to 0)
0
(-0.21 to 0.09)
0
(-0.45 to 0.23)
Change in log10 HIV VL at Week 28 (n=118; 91; 87)
0
(-0.43 to 0)
0
(-0.63 to 0.12)
0
(-0.46 to 0.17)
Change in log10 HIV VL at Week 52 (n=109; 85; 82)
0
(-0.53 to 0.08)
0
(-1.11 to 0)
0
(-1.28 to 0.44)
Change in log10 HIV VL at Week 72 (n=105; 81; 83)
0
(-0.59 to 0)
0
(-1.03 to 0)
0
(-1.93 to 0.15)
16.Secondary Outcome
Title Change in CD4 Cell Count From Baseline
Hide Description A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline.
Time Frame Weeks 0, 4, 8, 12, 24, 28, 52 and 72
Hide Outcome Measure Data
Hide Analysis Population Description
N=315 eligible participants who initiated intervention and had data available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=122; 92; 88. Week 8: n=119; 92; 90. Week 12: n=115; 87; 90. Week 24: n=117; 85; 88. Week 28: n=114; 89; 87. Week 52: n=108; 85; 87. Week 72: 105; 85; 88.
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description:
Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Overall Number of Participants Analyzed 127 95 93
Median (Inter-Quartile Range)
Unit of Measure: Cells/mm^3
Change in CD4 count at Week 4 (n=122; 92; 88)
31
(-52 to 94)
-3
(-45 to 29)
5
(-13 to 29)
Change in CD4 count at Week 8 (n=119; 92; 90)
21
(-66 to 118)
-8
(-59 to 58)
13
(-15 to 44)
Change in CD4 count at Week 12 (n=115; 87; 90)
5
(-99 to 104)
-3
(-42 to 63)
13
(-19 to 47)
Change in CD4 count at Week 24 (n=117; 85; 88)
12
(-66 to 92)
27
(-50 to 77)
12
(-31 to 71)
Change in CD4 count at Week 28 (n=114; 89; 87)
35
(-60 to 113)
37
(-49 to 104)
17
(-25 to 72)
Change in CD4 count at Week 52 (n=108; 85; 87)
6
(-119 to 117)
49
(-32 to 151)
40
(-28 to 113)
Change in CD4 count at Week 72 (n=105; 85; 88)
31
(-91 to 93)
65
(6 to 146)
46
(-26 to 133)
Time Frame From baseline to up to Week 72
Adverse Event Reporting Description The protocol required reporting of signs and symptoms and laboratory abnormalities of >=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
 
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24. Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
All-Cause Mortality
Stratum A Stratum B Stratum C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stratum A Stratum B Stratum C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/127 (4.72%)   2/95 (2.11%)   6/93 (6.45%) 
Blood and lymphatic system disorders       
Neutropenia  1  0/127 (0.00%)  1/95 (1.05%)  0/93 (0.00%) 
Gastrointestinal disorders       
Acute abdomen  1  0/127 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
General disorders       
Chest pain  1  0/127 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
Multi-organ failure  1  0/127 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
Infections and infestations       
Infection  1  0/127 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
Lobar pneumonia  1  1/127 (0.79%)  0/95 (0.00%)  1/93 (1.08%) 
Pneumocystis jiroveci pneumonia  1  0/127 (0.00%)  0/95 (0.00%)  1/93 (1.08%) 
Pneumonia  1  0/127 (0.00%)  0/95 (0.00%)  2/93 (2.15%) 
Injury, poisoning and procedural complications       
Brain herniation  1  1/127 (0.79%)  0/95 (0.00%)  0/93 (0.00%) 
Investigations       
Liver function test abnormal  1  1/127 (0.79%)  0/95 (0.00%)  0/93 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Intraductal proliferative breast lesion  1  1/127 (0.79%)  0/95 (0.00%)  0/93 (0.00%) 
Non-Hodgkin's lymphoma  1  1/127 (0.79%)  0/95 (0.00%)  0/93 (0.00%) 
Nervous system disorders       
Migraine  1  0/127 (0.00%)  1/95 (1.05%)  0/93 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  1/127 (0.79%)  0/95 (0.00%)  0/93 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stratum A Stratum B Stratum C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   96/127 (75.59%)   71/95 (74.74%)   82/93 (88.17%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  4/127 (3.15%)  2/95 (2.11%)  5/93 (5.38%) 
Gastrointestinal disorders       
Abdominal pain  1  11/127 (8.66%)  8/95 (8.42%)  12/93 (12.90%) 
Abdominal pain upper  1  5/127 (3.94%)  1/95 (1.05%)  7/93 (7.53%) 
Diarrhoea  1  6/127 (4.72%)  3/95 (3.16%)  15/93 (16.13%) 
Leukoplakia oral  1  1/127 (0.79%)  0/95 (0.00%)  5/93 (5.38%) 
Nausea  1  14/127 (11.02%)  6/95 (6.32%)  15/93 (16.13%) 
Vomiting  1  13/127 (10.24%)  4/95 (4.21%)  16/93 (17.20%) 
General disorders       
Chest pain  1  4/127 (3.15%)  5/95 (5.26%)  8/93 (8.60%) 
Chills  1  5/127 (3.94%)  2/95 (2.11%)  5/93 (5.38%) 
Fatigue  1  4/127 (3.15%)  6/95 (6.32%)  15/93 (16.13%) 
Injection site pain  1  4/127 (3.15%)  6/95 (6.32%)  3/93 (3.23%) 
Oedema peripheral  1  9/127 (7.09%)  2/95 (2.11%)  5/93 (5.38%) 
Pyrexia  1  15/127 (11.81%)  12/95 (12.63%)  22/93 (23.66%) 
Infections and infestations       
Bronchitis  1  10/127 (7.87%)  5/95 (5.26%)  4/93 (4.30%) 
Herpes simplex  1  5/127 (3.94%)  3/95 (3.16%)  5/93 (5.38%) 
Herpes zoster  1  0/127 (0.00%)  7/95 (7.37%)  2/93 (2.15%) 
Oral candidiasis  1  1/127 (0.79%)  2/95 (2.11%)  7/93 (7.53%) 
Upper respiratory tract infection  1  7/127 (5.51%)  6/95 (6.32%)  2/93 (2.15%) 
Urinary tract infection  1  9/127 (7.09%)  6/95 (6.32%)  7/93 (7.53%) 
Vaginitis bacterial  1  11/127 (8.66%)  12/95 (12.63%)  11/93 (11.83%) 
Vulvovaginal candidiasis  1  22/127 (17.32%)  8/95 (8.42%)  11/93 (11.83%) 
Vulvovaginitis trichomonal  1  5/127 (3.94%)  5/95 (5.26%)  1/93 (1.08%) 
Investigations       
Alanine aminotransferase increased  1  2/127 (1.57%)  7/95 (7.37%)  6/93 (6.45%) 
Aspartate aminotransferase increased  1  3/127 (2.36%)  9/95 (9.47%)  8/93 (8.60%) 
Blood bilirubin increased  1  6/127 (4.72%)  6/95 (6.32%)  6/93 (6.45%) 
Blood creatinine increased  1  4/127 (3.15%)  1/95 (1.05%)  10/93 (10.75%) 
Blood sodium decreased  1  0/127 (0.00%)  0/95 (0.00%)  5/93 (5.38%) 
Haemoglobin decreased  1  2/127 (1.57%)  5/95 (5.26%)  15/93 (16.13%) 
Neutrophil count decreased  1  10/127 (7.87%)  7/95 (7.37%)  18/93 (19.35%) 
White blood cell count decreased  1  0/127 (0.00%)  2/95 (2.11%)  14/93 (15.05%) 
Metabolism and nutrition disorders       
Decreased appetite  1  5/127 (3.94%)  1/95 (1.05%)  8/93 (8.60%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  6/127 (4.72%)  5/95 (5.26%)  4/93 (4.30%) 
Back pain  1  12/127 (9.45%)  8/95 (8.42%)  7/93 (7.53%) 
Myalgia  1  7/127 (5.51%)  0/95 (0.00%)  6/93 (6.45%) 
Pain in extremity  1  16/127 (12.60%)  10/95 (10.53%)  11/93 (11.83%) 
Nervous system disorders       
Dizziness  1  4/127 (3.15%)  3/95 (3.16%)  6/93 (6.45%) 
Headache  1  17/127 (13.39%)  11/95 (11.58%)  13/93 (13.98%) 
Paraesthesia  1  3/127 (2.36%)  0/95 (0.00%)  6/93 (6.45%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1  4/127 (3.15%)  5/95 (5.26%)  3/93 (3.23%) 
Psychiatric disorders       
Anxiety  1  2/127 (1.57%)  2/95 (2.11%)  6/93 (6.45%) 
Depression  1  9/127 (7.09%)  4/95 (4.21%)  7/93 (7.53%) 
Insomnia  1  3/127 (2.36%)  2/95 (2.11%)  5/93 (5.38%) 
Renal and urinary disorders       
Dysuria  1  7/127 (5.51%)  1/95 (1.05%)  5/93 (5.38%) 
Reproductive system and breast disorders       
Menorrhagia  1  2/127 (1.57%)  3/95 (3.16%)  5/93 (5.38%) 
Vaginal discharge  1  24/127 (18.90%)  8/95 (8.42%)  11/93 (11.83%) 
Vulvovaginal pruritus  1  17/127 (13.39%)  4/95 (4.21%)  4/93 (4.30%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  17/127 (13.39%)  12/95 (12.63%)  24/93 (25.81%) 
Dyspnoea  1  3/127 (2.36%)  8/95 (8.42%)  14/93 (15.05%) 
Nasal congestion  1  5/127 (3.94%)  2/95 (2.11%)  11/93 (11.83%) 
Oropharyngeal pain  1  4/127 (3.15%)  4/95 (4.21%)  11/93 (11.83%) 
Rhinorrhoea  1  1/127 (0.79%)  2/95 (2.11%)  8/93 (8.60%) 
Wheezing  1  2/127 (1.57%)  1/95 (1.05%)  5/93 (5.38%) 
Skin and subcutaneous tissue disorders       
Erythema  1  2/127 (1.57%)  5/95 (5.26%)  1/93 (1.08%) 
Pruritus  1  5/127 (3.94%)  3/95 (3.16%)  6/93 (6.45%) 
Skin lesion  1  8/127 (6.30%)  1/95 (1.05%)  5/93 (5.38%) 
Vascular disorders       
Hypertension  1  0/127 (0.00%)  5/95 (5.26%)  4/93 (4.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301)-628-3313
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00604175     History of Changes
Other Study ID Numbers: A5240
10393 ( Registry Identifier: DAIDS ES Registry Number )
ACTG A5240
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: July 15, 2013
Results First Posted: October 17, 2013
Last Update Posted: September 7, 2015