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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT00667563
First received: April 25, 2008
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: January 23, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
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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
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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
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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.
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
  Show 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 ]

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. ]

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

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

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

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.


Other Adverse Events
    Gardasil Vaccination
Total, other (not including serious) adverse events   
# participants affected / at risk   145/150 (96.67%) 
Gastrointestinal disorders   
Abdominal pain   
# participants affected / at risk   35/150 (23.33%) 
# events   41 
Dyspepsia   
# participants affected / at risk   19/150 (12.67%) 
# events   22 
Vomiting   
# participants affected / at risk   10/150 (6.67%) 
# events   11 
General disorders   
Fatigue   
# participants affected / at risk   27/150 (18.00%) 
# events   32 
Infections and infestations   
Lung Infection   
# participants affected / at risk   8/150 (5.33%) 
# events   8 
Skin Infection   
# participants affected / at risk   26/150 (17.33%) 
# events   29 
Upper Respiratory Infection   
# participants affected / at risk   44/150 (29.33%) 
# events   60 
Vaginal Infection   
# participants affected / at risk   21/150 (14.00%) 
# events   22 
Vulval Infection   
# participants affected / at risk   10/150 (6.67%) 
# events   10 
Metabolism and nutrition disorders   
Anorexia   
# participants affected / at risk   21/150 (14.00%) 
# events   24 
Musculoskeletal and connective tissue disorders   
Arthralgia   
# participants affected / at risk   9/150 (6.00%) 
# events   11 
Back pain   
# participants affected / at risk   27/150 (18.00%) 
# events   40 
Myalgia   
# participants affected / at risk   25/150 (16.67%) 
# events   34 
Pain in extremity   
# participants affected / at risk   45/150 (30.00%) 
# events   61 
Nervous system disorders   
Headache   
# participants affected / at risk   34/150 (22.67%) 
# events   47 
Reproductive system and breast disorders   
Vaginal Discharge   
# participants affected / at risk   21/150 (14.00%) 
# events   27 
Cough   
# participants affected / at risk   59/150 (39.33%) 
# events   87 
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain   
# participants affected / at risk   18/150 (12.00%) 
# events   22 
Skin and subcutaneous tissue disorders   
Pruritus   
# participants affected / at risk   41/150 (27.33%) 
# events   64 
Rash, maculo-papular   
# participants affected / at risk   14/150 (9.33%) 
# events   16 
* Events were collected by non-systematic assessment



  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