Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine in HIV-positive Spanish men who have sex with men (MSM)
| Autor: | Antonio Sampedro, Juan Pasquau, Concepción Gil-Anguita, Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Mohamed Omar-Mohamed-Balgahata, Javier Esquivias, Miguel Ángel López-Ruz |
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| Přispěvatelé: | [Hidalgo-Tenorio, Carmen] Univ Hosp Virgen de las Nieves, Infect Dis Serv, Granada, Spain, [Ramirez-Taboada, Jessica] Univ Hosp Virgen de las Nieves, Infect Dis Serv, Granada, Spain, [Gil-Anguita, Concepcion] Univ Hosp Virgen de las Nieves, Infect Dis Serv, Granada, Spain, [Lopez-Ruz, Miguel] Univ Hosp Virgen de las Nieves, Infect Dis Serv, Granada, Spain, [Pasquau, Juan] Univ Hosp Virgen de las Nieves, Infect Dis Serv, Granada, Spain, [Esquivias, Javier] Univ Hosp Virgen de las Nieves, Pathol Serv, Granada, Spain, [Omar-Mohamed-Balgahata, Mohamed] Hosp Ciudad Jaen, Infect Dis Unit, Jaen, Spain, [SamPedro, Antonio] Univ Hosp Virgen de las Nieves, Microbiol Serv, Granada, Spain, Public Health and Social Progress Foundation of the Government of Andalucia |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Male Anal Canal HIV Infections Antibodies Viral Anal intraepithelial neoplasia Men who have sex with men Placebos 0302 clinical medicine Human Papillomavirus Recombinant Vaccine Quadrivalent Types 6 11 16 18 Prevalence Pharmacology (medical) 030212 general & internal medicine Human papillomavirus 16 Hpv infection medicine.diagnostic_test Human papillomavirus 18 Coinfection Cohort Human immunodeficiency virus (HIV) Viral Load Anus Neoplasms Active antiretroviral therapy Risk-factors Molecular Medicine Men having sex with men (MSM) Viral load lcsh:Immunologic diseases. Allergy Adult medicine.medical_specialty 030106 microbiology Quadrivalent HPV vaccine Placebo 03 medical and health sciences Double-Blind Method Virology Internal medicine medicine Anal cancer Humans Pap test Viremia Risk factor Homosexuality Male Adverse effect business.industry Research Papillomavirus Infections medicine.disease CD4 Lymphocyte Count Spain Homosexual-men Cervical-cancer Immunology Linear Array HPV Genotyping Test Lesions Low squamous intra-epithelial lesion (LSIL) lcsh:RC581-607 business High squamous intra-epithelial lesions (HSIL) Cytology |
| Zdroj: | AIDS Research and Therapy AIDS Research and Therapy, Vol 14, Iss 1, Pp 1-12 (2017) |
| Popis: | 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® Pap Test), HPV PCR genotyping (Linear Array HPV Genotyping Test), and high-resolution anoscopy (Zeiss 150 fc© 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/µL (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. Clinical trial registration: ISRCTN14732216 (http://www.isrctn.com/ISRCTN14732216). |
| Databáze: | OpenAIRE |
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