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Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667563
First Posted: April 28, 2008
Last Update Posted: February 29, 2016
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.
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
Results First Submitted: January 23, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Nonneoplastic Condition
Precancerous Condition
Interventions: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Genetic: DNA analysis
Genetic: polymerase chain reaction
Other: cytology specimen collection procedure
Procedure: colposcopic biopsy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Participant Flow:   Overall Study
    Gardasil Vaccination
STARTED   150 
COMPLETED   126 
NOT COMPLETED   24 
Protocol Violation                24 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Enrolled in study

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Baseline Measures
   Gardasil Vaccination 
Overall Participants Analyzed 
[Units: Participants]
 150 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.8  (5.2) 
Gender 
[Units: Participants]
 
Female   150 
Male   0 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0   [ Time Frame: 52 weeks from study entry ]

Measure Type Primary
Measure Title Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
Measure Description Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
Time Frame 52 weeks from study entry  

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.
Intent-to-treat

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
   Gardasil Vaccination 
Participants Analyzed 
[Units: Participants]
 150 
Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0 
[Units: Grade 3/4 adverse events per 100 patient]
Number (95% Confidence Interval)
 6.0 
 (3.12 to 11.58) 

No statistical analysis provided for Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0



2.  Primary:   Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count   [ Time Frame: Screening/Week 0, Weeks 2, 10, 26, and 52. ]

Measure Type Primary
Measure Title Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
Measure Description Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
Time Frame Screening/Week 0, Weeks 2, 10, 26, and 52.  

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.
Intent-to-treat

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
   Gardasil Vaccination 
Participants Analyzed 
[Units: Participants]
 150 
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count 
[Units: Participants]
 11 

No statistical analysis provided for Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count



3.  Primary:   Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28   [ Time Frame: Week 28 ]

Measure Type Primary
Measure Title Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
Measure Description Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
Time Frame Week 28  

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.
Per-protocol population with undetectable HPV-16 levels at baseline

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
   Gardasil Vaccination 
Participants Analyzed 
[Units: Participants]
 96 
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28 
[Units: Participants]
 95 

No statistical analysis provided for Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28



4.  Primary:   Number of Patients With a Significant Increase in HIV Viral Load   [ Time Frame: Screening/week 0, weeks, 2, 10, 26 and 52 ]

Measure Type Primary
Measure Title Number of Patients With a Significant Increase in HIV Viral Load
Measure Description Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions
Time Frame Screening/week 0, weeks, 2, 10, 26 and 52  

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.
No text entered.

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
   Gardasil Vaccination 
Participants Analyzed 
[Units: Participants]
 150 
Number of Patients With a Significant Increase in HIV Viral Load 
[Units: Participants]
 7 

No statistical analysis provided for Number of Patients With a Significant Increase in HIV Viral Load



5.  Primary:   Number of Patients With Detectable Antibodies to HPV-6   [ Time Frame: 28 weeks ]

Measure Type Primary
Measure Title Number of Patients With Detectable Antibodies to HPV-6
Measure Description Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
Time Frame 28 weeks  

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.
Per-protocol participants with undetectable antibodies to HPV-6 at baseline

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
   Gardasil Vaccination 
Participants Analyzed 
[Units: Participants]
 88 
Number of Patients With Detectable Antibodies to HPV-6 
[Units: Participants]
 88 

No statistical analysis provided for Number of Patients With Detectable Antibodies to HPV-6



6.  Primary:   Number of Patients With Detectable Antibodies to HPV-11   [ Time Frame: 28 weeks ]

Measure Type Primary
Measure Title Number of Patients With Detectable Antibodies to HPV-11
Measure Description Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
Time Frame 28 weeks  

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.
Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
   Gardasil Vaccination 
Participants Analyzed 
[Units: Participants]
 111 
Number of Patients With Detectable Antibodies to HPV-11 
[Units: Participants]
 110 

No statistical analysis provided for Number of Patients With Detectable Antibodies to HPV-11



7.  Primary:   Number of Patients With Detectable Antibodies to HPV-18   [ Time Frame: 28 weeks ]

Measure Type Primary
Measure Title Number of Patients With Detectable Antibodies to HPV-18
Measure Description Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline
Time Frame 28 weeks  

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.
Per-protocol population of participants with undetectable HPV-18 antibodies at baseline

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
   Gardasil Vaccination 
Participants Analyzed 
[Units: Participants]
 104 
Number of Patients With Detectable Antibodies to HPV-18 
[Units: Participants]
 94 

No statistical analysis provided for Number of Patients With Detectable Antibodies to HPV-18




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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  More Information