RT Journal Article
T1 Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine in HIV-positive Spanish men who have sex with men (MSM)
A1 Hidalgo-Tenorio, Carmen
A1 Ramirez-Taboada, Jessica
A1 Gil-Anguita, Concepcion
A1 Esquivias, Javier
A1 Omar-Mohamed-Balgahata, Mohamed
A1 SamPedro, Antonio
A1 Lopez-Ruz, Miguel
A1 Pasquau, Juan
K1 Quadrivalent HPV vaccine
K1 High squamous intra-epithelial lesions (HSIL)
K1 Low squamous intra-epithelial lesion (LSIL)
K1 Human immunodeficiency virus (HIV)
K1 Men having sex with men (MSM)
K1 Anal cancer
K1 Anal intraepithelial neoplasia
K1 Active antiretroviral therapy
K1 Hpv infection
K1 Risk-factors
K1 Cervical-cancer
K1 Homosexual-men
K1 Cytology
K1 Prevalence
K1 Lesions
K1 Cohort
AB Background: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa.Methods: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine. The study enrolled from May 2012 to May 2014. Vaccine and placebo were administered at 0, 2 and 6 months (V1, V2, V3 clinical visits). Vaccine antibody titres were evaluated at 7 months. Cytology (Thin -Prep (R) Pap Test), HPV PCR genotyping (Linear Array HPV Genotyping Test), and high-resolution anoscopy (Zeiss 150 fc (c) colposcope) were performed at V1.Results: Patients (n = 162; mean age 37.9 years) were screened for inclusion; 14.2% had HSIL, 73.1% HR-HPV and 4.5% simultaneous infection with HPV16 and 18. Study participants (n = 129) were randomized to qHPV vaccine or placebo. The most common adverse event was injection-site pain predominating in the placebo group [the first dose (83.6% vs. 56.1%; p = 0.0001]; the second dose (87.8% vs. 98.4%; p = 0.0001); the third dose (67.7% vs. 91.9%; p = 0.0001). The vaccine did not influence either the viral load of HIV or the levels of CD4. Of those vaccinated, 76% had antibodies to HPV vs. 30.2% of those receiving placebo (p = 0.0001). In the multivariate analysis, Older age was associated with lower HR-HPV infection (RR 0.97; 95% CI 0.96-0.99), and risk factor were viral load of HIV >200 copies/mu L (RR 1.42 95% CI 1.17-1.73) and early commencement of sexual activity (RR 1.35; 95% CI 1.001-1.811).Conclusions: This trial showed significantly higher anti-HR-HPV antibody titres in vaccinated individuals than in unvaccinated controls. There were no serious adverse events attributable to the vaccine. In our cohort, 1 of every 7 patients had HSIL and the prevalence of combined infection by genotypes 16 and 18 was low. This suggests that patients could benefit from receiving qHPV vaccine. Older age was the main protective factor against HR-HPV infection, and non-suppressed HIV viremia was a risk factor.
PB Bmc
SN 1742-6405
YR 2017
FD 2017-07-18
LK http://hdl.handle.net/10668/14600
UL http://hdl.handle.net/10668/14600
LA en
DS RISalud
RD Apr 6, 2025