Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old.
J Acquir Immune Defic Syndr
; 55(2): 197-204, 2010 Oct.
Article
en En
| MEDLINE
| ID: mdl-20574412
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 (31 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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Infecciones por VIH
/
Vacunas contra Papillomavirus
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Child
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Female
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Humans
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Male
Idioma:
En
Año:
2010
Tipo del documento:
Article