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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00604175
First received: January 17, 2008
Last updated: August 11, 2015
Last verified: August 2015
Results First Received: July 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Infections
Sexually Transmitted Diseases
Intervention: Biological: Quadrivalent HPV vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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

Reporting Groups
  Description
Stratum A Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Stratum B 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.
Stratum C Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Participant Flow for 2 periods

Period 1:   Entry Through Week 28
    Stratum A   Stratum B   Stratum C
STARTED   130   95   94 
COMPLETED   120 [1]   92 [1]   93 [1] 
NOT COMPLETED   10   3   1 
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 2:   Week 29 Through Week 72
    Stratum A   Stratum B   Stratum C
STARTED   120   92   93 
COMPLETED   108   85   89 
NOT COMPLETED   12   7   4 
Death                0                0                1 
Lost to Follow-up                12                6                2 
Site closure                0                1                0 
Non-adherence to study requirements                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Stratum A Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Stratum B 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.
Stratum C Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Total Total of all reporting groups

Baseline Measures
   Stratum A   Stratum B   Stratum C   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   95   93   315 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 35 
 (29 to 40) 
 38 
 (33 to 42) 
 36 
 (31 to 40) 
 36 
 (30 to 41) 
Age, Customized 
[Units: 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 
Gender 
[Units: Participants]
       
Female   127   95   93   315 
Male   0   0   0   0 
Race/Ethnicity, Customized [1] 
[Units: 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] Race/ethnicity, self-reported (NIH categories).
Region of Enrollment 
[Units: Participants]
       
United States   113   80   69   262 
Brazil   11   6   11   28 
South Africa   3   9   13   25 
HIV Antiretroviral Therapy (ART) Status 
[Units: Participants]
       
On ART   58   71   80   209 
Not on ART   69   24   13   106 
CD4 Cell Count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 519 
 (418 to 664) 
 287 
 (246 to 344) 
 154 
 (86 to 188) 
 310 
 (197 to 498) 
Nadir CD4 Cell Count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 368 
 (234 to 482) 
 176 
 (64 to 261) 
 41 
 (20 to 108) 
 179 
 (47 to 314) 
HIV Viral Load [1] 
[Units: Participants]
       
<=10,000 copies/mL   71   69   61   201 
>10,000 copies/mL   56   25   32   113 
Unknown   0   1   0   1 
[1] 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] 
[Units: Participants]
       
Seronegative   66   60   56   182 
Seropositive   54   35   37   126 
Unknown   7   0   0   7 
[1] 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] 
[Units: Participants]
       
Seronegative   99   72   74   245 
Seropositive   22   23   19   64 
Unknown   6   0   0   6 
[1] 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] 
[Units: Participants]
       
Seronegative   77   65   67   209 
Seropositive   44   30   26   100 
Unknown   6   0   0   6 
[1] 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] 
[Units: Participants]
       
Seronegative   92   83   73   248 
Seropositive   29   12   20   61 
Unknown   6   0   0   6 
[1] 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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series   [ Time Frame: Week 28 ]

2.  Primary:   Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series   [ Time Frame: Week 28 ]

3.  Primary:   Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series   [ Time Frame: Week 28 ]

4.  Primary:   Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series   [ Time Frame: Week 28 ]

5.  Secondary:   HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline   [ Time Frame: Weeks 28, 72 ]

6.  Secondary:   HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline   [ Time Frame: Weeks 28, 72 ]

7.  Secondary:   HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline   [ Time Frame: Weeks 28, 72 ]

8.  Secondary:   HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline   [ Time Frame: Weeks 28, 72 ]

9.  Secondary:   Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline   [ Time Frame: Weeks 0, 28, 72 ]

10.  Secondary:   Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline   [ Time Frame: Weeks 0, 28, 72 ]

11.  Secondary:   Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline   [ Time Frame: Weeks 0, 28, 72 ]

12.  Secondary:   Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline   [ Time Frame: Weeks 0, 28, 72 ]

13.  Secondary:   Number of Participants With Signs and Symptoms of Grade 3 or Higher   [ Time Frame: From baseline to up to Week 72 ]

14.  Secondary:   Number of Participants With Laboratory Abnormalities of Grade 3 or Higher   [ Time Frame: From baseline to up to Week 72 ]

15.  Secondary:   Change in Log10 HIV Viral Load (VL) From Baseline   [ Time Frame: Weeks 0, 4, 12, 28, 52, and 72 ]

16.  Secondary:   Change in CD4 Cell Count From Baseline   [ Time Frame: Weeks 0, 4, 8, 12, 24, 28, 52 and 72 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301)-628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications of Results:
Other Publications:

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
Study First Received: January 17, 2008
Results First Received: July 15, 2013
Last Updated: August 11, 2015
Health Authority: United States: Food and Drug Administration