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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
week 0, 8, 24, 128
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine
Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine
Time frame: All study visits
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 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 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
Longitudinal Changes in CD4+ Cell Count From Baseline
CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.
Time frame: Week 0, 4, 12, 28
Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.
Time frame: Week 0, 4, 12, 28
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston University Cancer Research Center
Boston, Massachusetts, United States
Laser Surgery Care
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States
HPV antibody titers to type 6 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Time frame: weeks 0, 28, and 76
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
HPV antibody titers to type 11 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Time frame: weeks 0, 28, and 76
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
HPV antibody titers to type 16 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Time frame: weeks 0, 28, and 76
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
HPV antibody titers to type 18 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Time frame: weeks 0, 28, and 76
Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series
Time frame: Weeks 0, 28 and 76