Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women.

TitleImmunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women.
Publication TypeJournal Article
Year of Publication2014
AuthorsKojic EMilunka, Kang M, Cespedes MS, Umbleja T, Godfrey C, Allen RT, Firnhaber C, Grinsztejn B, Palefsky JM, Webster-Cyriaque JY, Saah A, Aberg JA, Cu-Uvin S
JournalClin Infect Dis
Volume59
Issue1
Pagination127-35
Date Published2014 Jul 1
ISSN1537-6591
KeywordsAdolescent, Adult, Antibodies, Viral, Brazil, CD4 Lymphocyte Count, Drug-Related Side Effects and Adverse Reactions, Female, HIV Infections, HIV-1, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18, Humans, Middle Aged, Papillomaviridae, Papillomavirus Infections, Papillomavirus Vaccines, South Africa, United States, Vaccination, Viral Load, Young Adult
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.

DOI10.1093/cid/ciu238
Alternate JournalClin. Infect. Dis.
PubMed ID24723284
PubMed Central IDPMC4305143
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