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Clin Infect Dis. 2014 Jul 1;59(1):127-35. doi: 10.1093/cid/ciu238. Epub 2014 Apr 9.

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

Author information

1
Department of Infectious Disease, Brown University, Providence, Rhode Island.
2
Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
3
Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.
4
HIV Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
5
AIDS Clinical Trials Group Network Coordinating Center, Silver Spring, Maryland.
6
Clinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
7
Infectious Diseases Department, Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Rio de Janeiro, Brazil.
8
Department of Medicine, University of California at San Francisco.
9
Oral HIV/AIDS Research Alliance (OHARA), Virology, Microbiology and Immunology, Dental Ecology, University of North Carolina, Chapel Hill.
10
Merck Research Labs, North Wales, Pennsylvania.

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.

KEYWORDS:

HIV-infected women; HPV vaccine; anogenital disease; immunogenicity; vaccine safety

PMID:
24723284
PMCID:
PMC4305143
DOI:
10.1093/cid/ciu238
[Indexed for MEDLINE]
Free PMC Article

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