Immunogenicity and Safety of the Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Women
Year: 2014
Type: article
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. Clinical Trials Registration. NCT00604175.
Source: Clinical Infectious Diseases
DOI: 10.1093/cid/ciu238
Institutions: Brown University, Harvard University, Icahn School of Medicine at Mount Sinai, National Institutes of Health, National Institute of Allergy and Infectious Diseases, AIDS Clinical Trials Group, University of the Witwatersrand, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, University of California, San Francisco, University of North Carolina at Chapel Hill, Merck & Co., Inc., Rahway, NJ, USA (United States)
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Massachusetts General Hospital, University of Southern California, Vanderbilt University, Wayne State University, University of Pennsylvania, Ohio State University, Northwestern University, University of Washington, Tulane University, Johns Hopkins University, University of Pittsburgh, Georgetown University, University of Rochester, University of Cincinnati, Rush University, Deutsches Krebsforschungszentrum, Virginia Commonwealth University, ACT Government, York University, Ministry of Education, India, National Institutes of Health, U.S. Public Health Service, Center for AIDS Research, University of Washington, University of California, San Diego, University of California, San Francisco, Center for Clinical and Translational Research, National Institute of Allergy and Infectious Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences, Center for AIDS Research, University of North Carolina at Chapel Hill
Awards: G1079176756, G1116104148, G1200945081, G123932167, CPCRA Clinical Trials Unit, G1346130624, G1432718094, G1479152345, G1534260048, G1663542656, UCLA Clinical and Translational Science Institute, G1838755991, G1852790566, Vanderbilt HIV Clinical Trials Unit, G193111053, G2075881678, G2094555266, G2199452652, G224570277, G226574744, G229144670, G2463412709, Miami HIV/AIDS Clinical Therapeutic and Vaccine Trial Unit, G2506163649, G2507544392, G2663518188, G2772878395, G2783911642, University of North Carolina AIDS Clinical Trials Unit (UNC ACTU), G2813232483, G2989067737, G3206931443, G3525517067, AIDS Clinical Trials Group Network, Alabama-Clinical Trials Unit, G367367271, G3788978964, G4012410710, G4044828089, G4205250407, Northwestern University Clinical Trial Unit, G4557552023, G4700763282, G5161777734, Integrated University of Puerto Rico Clinical Trials Unit, G5332695360, G5417339787, G5492247610, G5569078936, Center for Clinical and Translational Research, G5900455136, G5903087438, G6008919121, Institute for Clinical and Translational Research, Terry Beirn CPCRA Clinical Trials Unit, UNC Clinical and Translational Science Award, G672271569, G674907753, The University of Rochester's Clinical and Translational Science Institute, UCSF HIV Clinical Trials Unit, G7036227423, Clinical and Translational Science Center, G7254204816, Columbia Collaborative HIV/AIDS Clinical Trials Unit, G7348756, G7454575359, G755899205, G8059771280, G8575939001, Institute of Human Virology Clinical Trials Unit, G880164930, G8903843231, G8985174577, G9000010537, G9000015526, G9000031294, G9000041098, G9000041396, G9000057772, G9000088930, G9000156378, G9000191945, G9000222674, G9000230774, G9000231214, G9000240271, G9000253243, G9000276314, G9000277914, G9000294993, G9000299978, G9000332881, G9000347162, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, AIDS Clinical Trial Group Laboratory Center, Statistical and Data Management Center (SDMC), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), Penn Center for AIDS Research, The University of North Carolina Center for AIDS Research, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, San Francisco Bay Clinical Trials Unit (CTU), Seattle Clinical Trials Unit, Harvard University Center for AIDS Research, Boston HIV CTU, Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication, Miami Center for AIDS Research
OpenAlex ID: W2108018524