Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women.
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.
Department of Infectious Disease, Brown University, Providence, Rhode Island.
Erna Milunka
EM
Kojic
Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Minhee
M
Kang
Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.
Michelle S
MS
Cespedes
Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Triin
T
Umbleja
HIV Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Catherine
C
Godfrey
AIDS Clinical Trials Group Network Coordinating Center, Silver Spring, Maryland.
Reena T
RT
Allen
Clinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Cynthia
C
Firnhaber
Infectious Diseases Department, Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Rio de Janeiro, Brazil.
Beatriz
B
Grinsztejn
Department of Medicine, University of California at San Francisco.
Joel M
JM
Palefsky
Oral HIV/AIDS Research Alliance (OHARA), Virology, Microbiology and Immunology, Dental Ecology, University of North Carolina, Chapel Hill.
Jennifer Y
JY
Webster-Cyriaque
Merck Research Labs, North Wales, Pennsylvania.
Alfred
A
Saah
Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.
Judith A
JA
Aberg
Department of Infectious Disease, Brown University, Providence, Rhode Island.
Susan
S
Cu-Uvin
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D001938:Brazil; D018791:CD4 Lymphocyte Count; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015658:HIV Infections / Q000150:complications*; D015497:HIV-1 / Q000302:isolation & purification; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000276:immunology; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D013019:South Africa; D014481:United States; D014611:Vaccination / Q000009:adverse effects / Q000379:methods; D019562:Viral Load; D055815:Young Adult
D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines
HIV-infected women; HPV vaccine; anogenital disease; immunogenicity; vaccine safety