A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Infection
- Sponsor
- AIDS Malignancy Consortium
- Enrollment
- 112
- Locations
- 8
- Primary Endpoint
- Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.
PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.
Detailed Description
OBJECTIVES: Primary * To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men. * To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline. Secondary * To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series. * To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response. * To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline. * To evaluate the oral levels of serum IgA before and after the vaccination series. Tertiary * To evaluate prevalent and incident HPV infections in the anal canal. * To evaluate cytological and histological abnormalities in the anal canal. * To evaluate prevalent and incident HPV infections in the oral cavity. * To compare oral and anal compartmental shedding of HPV before and after vaccination. OUTLINE: This is a multicenter study. Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24. After completion of protocol therapy, patients are followed at 7, 12, and 18 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline
Time Frame: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline
Time Frame: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline
Time Frame: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline
Time Frame: Week 28
Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine
Time Frame: All study visits
Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine
Secondary Outcomes
- HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status(weeks 0, 28, and 76)
- Longitudinal Changes in CD4+ Cell Count From Baseline(Week 0, 4, 12, 28)
- HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status(weeks 0, 28, and 76)
- Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series(Weeks 0, 28 and 76)
- Longitudinal Changes in Plasma HIV-1 RNA From Baseline(Week 0, 4, 12, 28)
- HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status(weeks 0, 28, and 76)
- HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status(weeks 0, 28, and 76)