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Randomized Controlled Trial
. 2010 Oct;55(2):197-204.
doi: 10.1097/QAI.0b013e3181de8d26.

Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old

Myron J Levin  1 , Anna-Barbara Moscicki, Lin-Ye Song, Terrence Fenton, William A Meyer 3rd, Jennifer S Read, Edward L Handelsman, Barbara Nowak, Carlos A Sattler, Alfred Saah, David R Radley, Mark T Esser, Adriana Weinberg; IMPAACT P1047 Protocol Team
Collaborators, Affiliations
Randomized Controlled Trial

Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old

Myron J Levin et al. J Acquir Immune Defic Syndr. 2010 Oct.

Abstract

Background: Quadrivalent human papillomavirus vaccine (QHPV) is > 95% effective in preventing infection with vaccine-type human papillomavirus. The safety and immunogenicity of QHPV are unknown in HIV-infected children.

Methods: HIV-infected children (N = 126)-age > 7 to < 12 years, with a CD4% ≥ 15-and on stable antiretroviral therapy if CD4% was < 25-were blindly assigned to receive a dose of QHPV or placebo (3:1 ratio) at 0, 8, and 24 weeks. Adverse events were evaluated after each dose. Serum antibody against QHPV antigens was measured by a competitive Luminex immunoassay 1 month after the third QHPV dose.

Results: The safety profile of QHPV was similar in the 2 study arms and to that previously reported for QHPV recipients. QHPV did not alter the CD4% or plasma HIV RNA. Seroconversion to all 4 antigens occurred in > 96% of QHPV recipients and in no placebo recipients. Geometric mean titer was > 27 to 262 times greater than the seropositivity cutoff value, depending on the antigen, but was 30%-50% lower against types 6 and 18 than those of age-similar historical controls.

Conclusions: QHPV was safe and immunogenic in this cohort of HIV-infected children. Efficacy trials are warranted.

Trial registration: ClinicalTrials.gov NCT00339040.

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