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IMMUNOGENICITY AND SAFETY OF THE QUADRIVALENT HUMAN PAPILLOMAVIRUS VACCINE IN HIV-1– INFECTED WOMEN
Author
Affilliation
Brown University. Department of Infectious Disease. Providence, RI, United States of America
Harvard School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, United States of America
Icahn School of Medicine at Mount Sinai. Division of Infectious Diseases. New York City, NY, United Sates of America
Harvard School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, United States of America
National Institute of Allergy and Infectious Diseases. National Institutes of Health. HIV Research Branch. Therapeutics Research Program. Division of AIDS. Bethesda, MD, United States of America
AIDS Clinical Trials Group Network Coordinating Center. Silver Spring, MD, United States of America
University of the Witwatersrand. Department of Internal Medicine. Faculty of Health Sciences. Clinical HIV Research Unit. Johannesburg, South Africa
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil
University of California. Department of Medicine. San Francisco, CA, United States of America
University of North Carolina. Oral HIV/AIDS Research Alliance. Virology, Microbiology and Immunology, Dental Ecology. Chapel Hill, NC, United States of America
Merck Research Labs. North Wales, PA, United States of America
Icahn School of Medicine at Mount Sinai. Division of Infectious Diseases. New York City, NY, United Sates of America
Brown University. Department of Infectious Disease. Providence, RI, United States of America
Harvard School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, United States of America
Icahn School of Medicine at Mount Sinai. Division of Infectious Diseases. New York City, NY, United Sates of America
Harvard School of Public Health. Center for Biostatistics in AIDS Research. Boston, MA, United States of America
National Institute of Allergy and Infectious Diseases. National Institutes of Health. HIV Research Branch. Therapeutics Research Program. Division of AIDS. Bethesda, MD, United States of America
AIDS Clinical Trials Group Network Coordinating Center. Silver Spring, MD, United States of America
University of the Witwatersrand. Department of Internal Medicine. Faculty of Health Sciences. Clinical HIV Research Unit. Johannesburg, South Africa
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil
University of California. Department of Medicine. San Francisco, CA, United States of America
University of North Carolina. Oral HIV/AIDS Research Alliance. Virology, Microbiology and Immunology, Dental Ecology. Chapel Hill, NC, United States of America
Merck Research Labs. North Wales, PA, United States of America
Icahn School of Medicine at Mount Sinai. Division of Infectious Diseases. New York City, NY, United Sates of America
Brown University. Department of Infectious Disease. Providence, RI, United States of America
Abstract
Background. Women infected with human immunodeficiency virus (HIV) are disproportionately affected by human papillomavirus (HPV)–related anogenital disease, particularly with increased immunosuppression. AIDS Clinical Trials Group protocol A5240 was a trial of 319 HIV-infected women in the United States, Brazil, and South Africa to determine immunogenicity and safety of the quadrivalent HPV vaccine in 3 strata based on screening CD4 count: >350 (stratum A), 201–350 (stratum B), and ≤200 cells/µL (stratum C).
Methods. Safety and serostatus of HPV types 6, 11, 16, and 18 were examined. HPV serological testing was performed using competitive Luminex immunoassay (HPV-4 cLIA). HPV type-specific seroconversion analysis was done for participants who were seronegative for the given type at baseline.
Results. Median age of patients was 36 years; 11% were white, 56% black, and 31% Hispanic. Median CD4 count was 310 cells/µL, and 40% had undetectable HIV-1 load. No safety issues were identified. Seroconversion proportions among women at week 28 for HPV types 6, 11,16, and 18 were 96%, 98%, 99%, and 91%, respectively, for stratum A; 100%, 98%, 98%, and 85%, respectively, for stratum B, and 84%, 92%, 93%, and 75%, respectively, for stratum C.
Conclusions. The quadrivalent HPV vaccine targeted at types 6, 11, 16, and 18 was safe and immunogenic in HIV-infected women aged 13–45 years. Women with HIV RNA load >10 000 copies/mL and/or CD4 count <200 cells/µL had lower rates of seroconversion rates.
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