Journal Article

Immunogenicity and Safety of the Quadrivalent Human Papillomavirus Vaccine in HIV-1–Infected Women

Godfrey, Catherine, Palefsky, Joel M., Aberg, Judith A., Umbleja, Triin, Cu-Uvin, Susan, Kojic, Erna Milunka, Allen, Reena T., Saah, Alfred, Grinsztejn, Beatriz, Kang, Minhee, Firnhaber, Cynthia, Cespedes, Michelle S., Webster-Cyriaque, Jennifer Y.

2014

Overview

Background. Women infected with human immunodeficiency virus (HIV) are disproportionately affected by human papillomavirus (HPV)–related anogenital disease, particularly with increased immunosuppressions. 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.

• Publisher: OXFORD UNIVERSITY PRESS,Oxford University Press
• Subject: Adolescent / Adult / AIDS / Antibodies / Antibodies, Viral - blood / Biological and medical sciences / Brazil / CD4 Lymphocyte Count / Clinical outcomes / Clinical trials / Drug-Related Side Effects and Adverse Reactions / Female / HIV / HIV 1 / HIV infections / HIV Infections - complications / HIV-1 - isolation & purification / HIV/AIDS / Human immunodeficiency virus / Human papillomavirus / Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Human viral diseases / Humans / Immune response / Immunodeficiencies / Immunodeficiencies. Immunoglobulinopathies / Immunogenicity / Immunopathology / Infectious diseases / Lentivirus / Medical sciences / Middle Aged / Papillomaviridae / Papillomaviridae - immunology / Papillomavirus Infections - prevention & control / Papillomavirus vaccines / Papillomavirus Vaccines - adverse effects / Papillomavirus Vaccines - immunology / Patient safety / Registered nurses / Retroviridae / RNA / Safety / South Africa / United States / Vaccination - adverse effects / Vaccination - methods / Vaccines / Viral diseases / Viral diseases of the lymphoid tissue and the blood. Aids / Viral Load / Womens health / Young Adult