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Tytuł:
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Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study.
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Autorzy:
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Mikamo H; Aichi Medical University Hospital, Nagakute, Japan.
Yamagishi Y; Aichi Medical University Hospital, Nagakute, Japan.
Murata S; MSD K.K., Tokyo, Japan. Electronic address: .
Yokokawa R; MSD K.K., Tokyo, Japan.
Han SR; MSD K.K., Tokyo, Japan.
Wakana A; MSD K.K., Tokyo, Japan.
Sawata M; MSD K.K., Tokyo, Japan.
Tanaka Y; MSD K.K., Tokyo, Japan.
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Źródło:
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Vaccine [Vaccine] 2019 Mar 14; Vol. 37 (12), pp. 1651-1658. Date of Electronic Publication: 2019 Feb 20.
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Typ publikacji:
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Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
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MeSH Terms:
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Immunogenicity, Vaccine*
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18/*immunology
Papillomavirus Infections/*prevention & control
Adolescent ; Adult ; Homosexuality, Male ; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18/administration & dosage ; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18/adverse effects ; Humans ; Japan/epidemiology ; Male ; Papillomavirus Infections/epidemiology ; Papillomavirus Infections/transmission ; Patient Outcome Assessment ; Risk Factors ; Sex Factors ; Vaccination/methods ; Young Adult
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Contributed Indexing:
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Keywords: Adult male; Human papillomavirus; Japan; Prophylactic efficacy; Quadrivalent HPV vaccine; Safety
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Molecular Sequence:
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ClinicalTrials.gov NCT01862874
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Substance Nomenclature:
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0 (Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18)
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Entry Date(s):
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Date Created: 20190225 Date Completed: 20200629 Latest Revision: 20200629
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Update Code:
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20240104
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DOI:
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10.1016/j.vaccine.2019.01.069
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PMID:
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30797638
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Background: The quadrivalent (q) human papillomavirus (HPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, and 18. We report efficacy, immunogenicity, and safety of qHPV vaccine in a Phase 3 study in Japanese men.
Methods: In this randomized, double-blind trial (NCT01862874), Japanese men (aged 16-26 years) were randomized in a 1:1 ratio to receive three doses of qHPV vaccine or placebo (Day 1, Month 2, Month 6). The primary efficacy endpoint was the combined incidence of HPV6/11/16/18-related persistent anogenital infection (detected at ≥2 consecutive visits ≥6 months apart), assessed in the per-protocol population of men who received all three vaccinations, and were seronegative at Day 1 and PCR negative from Day 1 to Month 7 to the relevant HPV type. Results are from the interim and final analyses.
Results: In total, 1124 participants were randomized. The vaccine demonstrated 83.3% (95% confidence interval: 24.9, 98.2; p = 0.007) and 85.9% (95% confidence interval: 52.7, 97.3; p < 0.001) efficacy against HPV6/11/16/18-related persistent infection in the interim and final analyses, respectively. Two cases of HPV6/11/16/18-related external genital lesions (condyloma and PIN 1) were observed in the placebo group and none in the qHPV vaccine group at study end. At Month 7, >97% of participants who received qHPV vaccine seroconverted to each of the vaccine HPV types. Most participants remained seropositive at Month 36, although the seropositivity rate declined between Months 7 and 36. Vaccination-related adverse events were reported in 60.8% and 56.5% of participants in the qHPV vaccine and placebo groups, respectively; most commonly mild to moderate injection-site pain, erythema, and swelling. Injection-site pain and swelling were more common with qHPV vaccine than placebo (each p < 0.05).
Conclusions: Results suggest qHPV vaccine is efficacious against HPV6/11/16/18-related persistent infections, immunogenic, and well-tolerated in Japanese men. Clinical trial registration identifier: NCT01862874.
(Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)
