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Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00339040
First received: June 19, 2006
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
Results First Received: September 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: HIV Infections
Sexually Transmitted Diseases
Interventions: Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
Other: Placebo/QHPV

  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
Between October 11, 2006 and November 22, 2006 130 participants were enrolled at 34 clinical sites from US & Puerto Rico.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified by CD4% criteria. Four participants were randomized but did not receive the study treatment. The study analyses were based on 126 participants who received the study treatment.

Reporting Groups
  Description
Arm A QHPV Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Arm B Placebo/QHPV Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.

Participant Flow for 2 periods

 Period 1:   Stage I
    Arm A QHPV     Arm B Placebo/QHPV  
STARTED     96     30  
Vaccination 1 at Week 0     96     30  
Vaccination 2 at Week 8     95     30  
Vaccination 3 at Week 24     94     30  
COMPLETED     94     29  
NOT COMPLETED     2     1  
Not able to attend clinic                 1                 0  
Protocol Violation                 1                 1  

Period 2:   Stage II
    Arm A QHPV     Arm B Placebo/QHPV  
STARTED     94     29  
Vaccination 4 at Week 96     84     29  
Vaccination 5 at Week 104     0     28  
Vaccination 6 at Week 120     0     27  
COMPLETED     84     27  
NOT COMPLETED     10     2  
Lost to Follow-up                 3                 0  
Withdrawal by Subject                 1                 2  
Protocol Violation                 3                 0  
Not able to attend clinic                 1                 0  
Site closing                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Arm A QHPV Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Arm B Placebo/QHPV Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Total Total of all reporting groups

Baseline Measures
    Arm A QHPV     Arm B Placebo/QHPV     Total  
Number of Participants  
[units: participants]
 		  96     30     126  
Age  
[units: years]
Mean ± Standard Deviation 		  10.0  ± 1.4     9.9  ± 1.3     9.9  ± 1.4  
Gender  
[units: participants]
 		     
Female     53     18     71  
Male     43     12     55  
Race/Ethnicity, Customized  
[units: participants]
 		     
White, non-Hispanic     4     2     6  
Black, non-Hispanic     54     11     65  
Hispanic     37     14     51  
Others     1     3     4  
Stratification groups [1]
[units: participants]
 		     
Stratum A     31     10     41  
Stratum B     32     11     43  
Stratum C     33     9     42  
CD4 count  
[units: cells/µL]
Mean ± Standard Deviation 		  868  ± 367     1013  ± 455     903  ± 393  
CD4%  
[units: percentage of total lymphocytes]
Mean ± Standard Deviation 		  33.9  ± 7.9     35.8  ± 8.6     34.3  ± 8.1  
Log10(RNA)  
[units: Log10(copies/mL)]
Mean ± Standard Deviation 		  2.7  ± 0.9     2.6  ± 0.8     2.7  ± 0.9  
RNA group  
[units: participants]
 		     
≤400 copies/mL     65     22     87  
401 to ≤5000 copies/mL     16     5     21  
>5000 copies/mL     15     3     18  
[1]

STRATIFICATION: Participant were stratified by CD4% criteria into three strata:

  • Stratum A: CD4% Nadir < 15 and CD4% ≥ 15 at screening
  • Stratum B: CD4% Nadir ≥ 15 and < 25 and CD4% ≥ 15 at screening
  • Stratum C: CD4% Nadir ≥ 25 and CD4% ≥ 25 at screening



  Outcome Measures
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1.  Primary:   Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)   [ Time Frame: Within 14 days of first three doses of vaccination ]
  Show Outcome Measure 1

2.  Primary:   Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment   [ Time Frame: Within 14 days of first three doses of vaccination ]
  Show Outcome Measure 2

3.  Primary:   Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion   [ Time Frame: At week 28 after beginning the vaccination series ]
  Hide Outcome Measure 3

Measure Type Primary
Measure Title Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion
Measure Description Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.
Time Frame At week 28 after beginning the vaccination series  
Safety Issue No  

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.
The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.

Reporting Groups
  Description
Arm A QHPV Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Arm B Placebo/QHPV Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.

Measured Values
    Arm A QHPV     Arm B Placebo/QHPV  
Number of Participants Analyzed  
[units: participants]
 		  96     30  
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion  
[units: percent of participants]
Number ( 95% Confidence Interval ) 		   
Serotype 6 (n=87, 27)     100.0  
  ( 95.9 to 100.0 )   		  0.0  
  ( 0.0 to 12.8 )  
Serotype 11 (n=90, 27)     100.0  
  ( 95.9 to 100.0 )   		  0.0  
  ( 0.0 to 12.8 )  
Serotype 16 (n=90, 27)     100.0  
  ( 95.9 to 100.0 )   		  3.7  
  ( 0.1 to 19.0 )  
Serotype 18 (n=90, 27)     96.7  
  ( 90.6 to 99.3 )   		  0.0  
  ( 0.0 to 12.8 )  

No statistical analysis provided for Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion



4.  Primary:   Serum Anti-HPV Antibody Titers (cLIA)   [ Time Frame: Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124. ]
  Show Outcome Measure 4

5.  Secondary:   CD4 Count Over Time   [ Time Frame: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124. ]
  Show Outcome Measure 5

6.  Secondary:   CD4 Percent Over Time   [ Time Frame: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124. ]
  Show Outcome Measure 6

7.  Secondary:   HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time   [ Time Frame: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124. ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications of Results:

Other Publications:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00339040     History of Changes
Other Study ID Numbers: P1047, 10163, PACTG P1047
Study First Received: June 19, 2006
Results First Received: September 7, 2011
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration