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)

Aberg, Judith A.

Allen, Reena T.

Cespedes, Michelle S.

Cu-Uvin, Susan

Firnhaber, Cynthia

Godfrey, Catherine

Grinsztejn, Beatriz

Kang, Minhee

Kojic, Erna Milunka

Palefsky, Joel M.

Saah, Alfred

Umbleja, Triin

Webster-Cyriaque, Jennifer Y.

PubMed

Carolina Digital Repository

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

Grinsztejn, Beatriz Gilda Jegerhorn

Cyriaque, Jennifer Y. Webster

RCAAP - Repositório Científico de Acesso Aberto de Portugal

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

BackgroundWomen 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: &gt;350 (stratum A), 201-350 (stratum B), and ≤200 cells/µL (stratum C).MethodsSafety 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.ResultsMedian 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.ConclusionsThe 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 &gt;10 000 copies/mL and/or CD4 count &lt;200 cells/µL had lower rates of seroconversion rates. Clinical Trials Registration. NCT00604175

Cespedes, Michelle S

Allen, Reena T

Palefsky, Joel M

Webster-Cyriaque, Jennifer Y

Aberg, Judith A

eScholarship - University of California

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

https://cdr.lib.unc.edu/downloads/5m60r016q

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

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RCAAP - Repositório Científico de Acesso Aberto de Portugal

eScholarship - University of California