{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T00:33:28Z","timestamp":1789173208486,"version":"build-2803163510"},"reference-count":27,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2021,1,20]],"date-time":"2021-01-20T00:00:00Z","timestamp":1611100800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100015757","name":"Fundaci\u00f3n P\u00fablica Andaluza Progreso y Salud","doi-asserted-by":"publisher","award":["(#PI-0615-2011)"],"award-info":[{"award-number":["(#PI-0615-2011)"]}],"id":[{"id":"10.13039\/501100015757","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Anal squamous cell carcinoma is the most frequent virus-related non-AIDS-defining neoplasia among HIV-infected individuals, especially MSM. The objectives of this study were to analyze the effectiveness of the quadrivalent HPV (qHPV) vaccine to prevent anal \u2265 high-grade squamous intraepithelial lesions (\u2265HSILs), external ano-genital lesions (EAGLs), and infection by qHPV vaccine genotypes in HIV+ MSM, and to study the immunogenicity of the vaccine and risk factors for \u2265 HSILs. This study is nested within a randomized, double-blind, placebo-controlled trial of the qHPV vaccine, which enrolled participants between May 2012 and May 2014, with a 48-month follow-up. A vaccine or placebo was administered at 0, 2, and 6 months, and vaccine antibody titers were evaluated at 7, 12, 24, 36, and 48 months. Data were gathered at 12, 24, 36, and 48 months on sexual habits, CD4\/CD8 cell\/counts, HIV viral load, and the results of cytology (Thin Prep\u00ae Pap Test), HPV PCR genotyping (Linear Array HPV Genotyping Test), and high-resolution anoscopy (Zeiss 150 fc\u00a9 colposcope). The study included 129 patients (mean age of 38.8 years, 40 [31%] with a history of AIDS, 119 [92.2%] receiving ART, and 4 [3.3%] with virological failure), 66 (51.2%) in vaccine arm and 63 (48.4%) in placebo arm. The vaccine and placebo groups did not differ in \u2265 HSILs (14.1 vs. 13.1%, respectively, p = 0.98) or EAGL (11.1 vs. 6.8%, p = 0.4) rates during follow-up; however, a protective effect against HPV 6 was observed during the first year of follow-up in the vaccine versus placebo group (7.5% vs. 23.4%; p = 0.047). A between-arm difference (p = 0.0001) in antibodies against qHPV vaccine genotypes was observed at 7 months (76.9% in vaccine arm vs. 30.2% in placebo arm), 12 months (68.1% vs. 26.5%), 24 months (75% vs. 32.5%), 36 months (90% vs. 24.4%), and 48 months (87.2% vs. 30%). Finally, the factor associated with the risk of anal \u2265 HSIL onset during the four-year follow-up was the receipt of the last dose of the vaccine less than 6 months earlier in comparison to those vaccinated for a longer period (82.4% vs. 17.6% (OR 0.869 [95% CI, 0.825\u20130.917]). Vaccine and placebo arms did not significantly differ in \u2265 HSIL or EAGL rates or in protection against infection by HPV genotype vaccine except for HPV6 at 12 months after the first dose. A long-lasting immune response was observed in almost all the vaccinated men. The main protective factor against \u2265 HSIL was to have completed the vaccination regimen more than 6 months earlier.<\/jats:p>","DOI":"10.3390\/v13020144","type":"journal-article","created":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T02:36:05Z","timestamp":1611196565000},"page":"144","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Effectiveness of the Quadrivalent HPV Vaccine in Preventing Anal \u2265 HSILs in a Spanish Population of HIV+ MSM Aged &gt; 26 Years"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6394-5728","authenticated-orcid":false,"given":"Carmen","family":"Hidalgo-Tenorio","sequence":"first","affiliation":[{"name":"Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Pasquau","sequence":"additional","affiliation":[{"name":"Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Omar-Mohamed","sequence":"additional","affiliation":[{"name":"Infectious Disease Unit, Complejo Hospitalario Ja\u00e9n, 23007 Ja\u00e9n, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Sampedro","sequence":"additional","affiliation":[{"name":"Microbiology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel A.","family":"L\u00f3pez-Ruz","sequence":"additional","affiliation":[{"name":"Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9106-2028","authenticated-orcid":false,"given":"Javier","family":"L\u00f3pez Hidalgo","sequence":"additional","affiliation":[{"name":"Pathology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Ram\u00edrez-Taboada","sequence":"additional","affiliation":[{"name":"Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,1,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1097\/QAI.0b013e3181b327ca","article-title":"A meta-analysis of the incidence of non-AIDS cancers in HIV-infected individuals","volume":"52","author":"Shiels","year":"2009","journal-title":"J. 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