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



  • 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.


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

publication date

  • April 9, 2014



  • HIV Infections
  • Papillomavirus Infections
  • Papillomavirus Vaccines


PubMed Central ID

  • PMC4305143

Scopus Document Identifier

  • 84903944942

Digital Object Identifier (DOI)

  • 10.1093/cid/ciu238

PubMed ID

  • 24723284

Additional Document Info


  • 59


  • 1