A recent trial provides encouraging evidence that vaccination against other infectious diseases may provide protection for persons infected with HIV.
Human papillomavirus (HPV) infections can cause anal and cervical intraepithelial neoplasia and subsequently cancer. HIV-infected women are at higher risk for these conditions. One potential prevention strategy is vaccination against HPV. Previous research, however, has suggested that HIV-infected patients may have poor response to vaccination against other viruses such as hepatitis A and B viruses.
A recent clinical trial published in the journal Clinical Infectious Diseases1 examined the efficacy and safety of the quadrivalent HPV vaccine in HIV-infected women, including those with low CD4 counts.
The international phase 2, open-label, single-arm study was designed to assess the immunogenicity and safety of the quadrivalent HPV recombinant vaccine (Gardasil). Investigators stratified the study population based on CD4 counts: >350 ≤200 cells/µL (stratum A); 201-350 ≤200 cells/µL (stratum B); and ≤200 cells/µL (stratum C). The study included women between the ages of 13 and 45 years with documented HIV infection. Patients who already had a diagnosis of high-grade cervical intraepithelial neoplasia, vaginal intraepithelial neoplasia, or genital warts within 180 days before study enrollment were excluded. The participants received the quadrivalent HPV vaccine at entry, at week 8, and at week 24.
Results were encouraging. At week 28, the seroconversion rates among women in CD4 stratum A were 96%, 98%, 99%, and 91% for HPV types 6, 11, 16, and 18, respectively; among women in stratum B the rates were 100%, 98%, 98%, and 85%, respectively; and in stratum C the rates were 84%, 92%, 93%, 75% for each type, respectively. No safety issues were identified.
This multicenter trial showed that the quadrivalent HPV vaccine against type 6, 11, 16, and 18 is safe and induced immunogenicity in HIV-infected women between the ages of 13 and 45. Seroconverison rates were lower in women with high viral loads or lower CD4 counts.
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Kojic EM, Kang M, Cespedes MS, et al. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis. Published online ahead of print April 9, 2014. doi: 10.1093/cid/ciu238.