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Effectiveness of the Quadrivalent HPV Vaccine in Preventing Anal ≥ HSILs in a Spanish Population of HIV+ MSM Aged > 26 Years
- Source :
- Viruses, Vol 13, Iss 144, p 144 (2021), Viruses
- Publication Year :
- 2021
- Publisher :
- MDPI AG, 2021.
-
Abstract
- 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 ≥ high-grade squamous intraepithelial lesions (≥HSILs), 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 ≥ 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® Pap Test), HPV PCR genotyping (Linear Array HPV Genotyping Test), and high-resolution anoscopy (Zeiss 150 fc© 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 ≥ 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 ≥ 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, 0.825–0.917]). Vaccine and placebo arms did not significantly differ in ≥ 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 ≥ HSIL was to have completed the vaccination regimen more than 6 months earlier.
- Subjects :
- Adult
Male
medicine.medical_specialty
anal cancer
lcsh:QR1-502
Anal Canal
HIV Infections
Antibodies, Viral
Placebo
Article
lcsh:Microbiology
Sexual and Gender Minorities
03 medical and health sciences
0302 clinical medicine
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Acquired immunodeficiency syndrome (AIDS)
Virology
Internal medicine
medicine
Humans
Anal cancer
030212 general & internal medicine
men who have sex with men (MSM)
Homosexuality, Male
medicine.diagnostic_test
Coinfection
business.industry
Papillomavirus Infections
Anal Squamous Cell Carcinoma
Anoscopy
Middle Aged
Viral Load
anal high-grade squamous intraepithelial lesion (HSIL)
Anus Neoplasms
medicine.disease
CD4 Lymphocyte Count
Vaccination
quadrivalent HPV vaccine
human immunodeficiency virus (HIV)
Infectious Diseases
Spain
030220 oncology & carcinogenesis
Multivariate Analysis
Linear Array HPV Genotyping Test
Regression Analysis
business
Viral load
Subjects
Details
- Language :
- English
- ISSN :
- 19994915
- Volume :
- 13
- Issue :
- 144
- Database :
- OpenAIRE
- Journal :
- Viruses
- Accession number :
- edsair.doi.dedup.....aaf679a4ff169e50f5240b90f40ce50e