NCT00513526CompletedPhase 2
A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men
AIDS Malignancy Consortium14 sites in 1 country112 target enrollmentStarted: November 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 112
- Locations
- 14
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
- •HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
- •Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry
- •If receiving antiretroviral therapy:
- •Receipt of antiretroviral therapy for at least 6 months prior to entry
- •No change in antiretroviral therapy within 30 days prior to entry
- •CD4 cell count > 200 cells/mm³ within 90 days prior to study entry
- •HIV-1 RNA < 200 copies/mL within 90 days prior to entry
- •If not receiving antiretroviral therapy:
- •CD4 cell count ≥ 350 cells/mm³ within 90 days prior to study entry
- •No plans to start antiretroviral therapy prior to week 28
- •Normal anal cytological result, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry
Exclusion Criteria
- •Current or history of anal or perianal carcinoma
- •Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results
- •Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN
- •Current or history of anal or peri-anal condyloma is allowed
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •Karnofsky performance status 70-100%
- •Absolute neutrophil count > 750 cells/mm³
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 100,000/mm³
- •Creatinine clearance ≥ 60 mL/min
- •AST and ALT ≤ 3 times ULN
- •Total or conjugated (direct) bilirubin ≤ 2.5 times ULN
- •Exclusion criteria:
- •Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
- •Serious illness requiring systemic treatment and/or hospitalization within the past 45 days
- •Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- •Hemophilia
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •See Disease Characteristics
- •Exclusion criteria:
- •Prior splenectomy
- •Currently receiving anticoagulation therapy other than acetylsalicylic acid
- •Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
- •Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded
- •Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C
- •Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other HPV vaccine
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)
Investigators
Study Sites (14)
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