A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men
- 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.
- To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination
- To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody
- 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.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine
All study visits
Timothy J. Wilkin, MD, MPH
Weill Medical College of Cornell University
United States: Federal Government
|Montefiore Medical Center||Bronx, New York 10467-2490|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Denver Health Medical Center||Denver, Colorado 80204-4507|
|UCLA Clinical AIDS Research and Education (CARE) Center||Los Angeles, California 90024|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|
|Benaroya Research Institute at Virginia Mason Medical Center||Seattle, Washington 98101|
|Laser Surgery Care||New York, New York 10011|