Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old.
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.
Levin
Myron J
MJ
Department of Pediatrics, University of Colorado Denver School of Medicine, Aurora, CO, USA. myron.levin@ucdenver.edu
Moscicki
Anna-Barbara
AB
Song
Lin-Ye
LY
Fenton
Terrence
T
Meyer
William A
WA
Read
Jennifer S
JS
Handelsman
Edward L
EL
Nowak
Barbara
B
Sattler
Carlos A
CA
Saah
Alfred
A
Radley
David R
DR
Esser
Mark T
MT
Weinberg
Adriana
A
D000914:Antibodies, Viral / Q000276:immunology; D018791:CD4 Lymphocyte Count; D002648:Child; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D016014:Linear Models; D008297:Male; D027383:Papillomaviridae / Q000276:immunology; D053918:Papillomavirus Vaccines / Q000009:adverse effects / Q000276:immunology*; D019562:Viral Load
D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines