A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men

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• 作者：Pierre Van Damme^a ; ^{pierre.vandamme@uantwerpen.be" class="auth_mail" title="E-mail the corresponding author} ; Chris J.L.M. Meijer^b ; ^{CJLM.Meijer@vumc.nl" class="auth_mail" title="E-mail the corresponding author} ; Dorothee Kieninger^c ; ^{Dorothee.kieninger@unimedizin-mainz.de" class="auth_mail" title="E-mail the corresponding author} ; Anne Schuyleman^d ; ^{ASchuyleman@spmsd.com" class="auth_mail" title="E-mail the corresponding author} ; Stephane Thomas^d ; ^{SThomas@spmsd.com" class="auth_mail" title="E-mail the corresponding author} ; Alain Luxembourg^e ; ^{alain_luxembourg@merck.com" class="auth_mail" title="E-mail the corresponding author} ; Martine Baudin^d ; ^{baudinmartine@yahoo.fr" class="auth_mail" title="E-mail the corresponding author}
• 关键词：9vHPV vaccine ; 9-valent HPV vaccine ; AE ; adverse event ; ANOVA ; analysis of variance ; CI ; confidence interval ; cLIA ; competitive Luminex immunoassay ; EU ; European Union ; GMTs ; geometric mean titres ; HPV ; human papilloma virus ; qHPV vaccine ; quadrivalent HPV vaccine ; SAE ; serious adverse event ; USA ; United States of America ; VLP ; virus-like particle ; VRC ; vaccination report card
• 刊名：Vaccine
• 出版年：2016
• 出版时间：29 July 2016
• 年：2016
• 卷：34
• 期：35
• 页码：4205-4212
• 全文大小：320 K

文摘

A nine-valent human papilloma virus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 (as per the licensed quadrivalent HPV (qHPV) vaccine) as well as to five additional oncogenic HPV types (HPV 31/33/45/52/58). The 9vHPV vaccine has the potential to prevent 90% of cervical cancers, HPV-related anal, vaginal and vulval cancers and anogenital warts. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 16–26-year-old men.

Methods

Participants (N = 500) were randomised to receive 9vHPV or qHPV vaccines on day 1, month 2 and month 6. Serology testing was performed on day 1 and month 7. HPV type-specific antibody titres (anti-HPV 6/11/16/18/31/33/45/52/58) were determined by competitive Luminex immunoassay and expressed as geometric mean titres and seroconversion rates. Vaccine safety was also assessed.

Results

The HPV 6/11/16/18 immune responses elicited by the 9vHPV vaccine were comparable with those elicited by the qHPV vaccine. All participants receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles.

Conclusions

In addition to immune responses to HPV 31/33/45/52/58, a three-dose regimen of the 9vHPV vaccine elicited a similar immune response to HPV 6/11/16/18 when compared with the qHPV vaccine in men aged 16–26 years. The safety profile was also similar for the two vaccines. The results from this study support extending the efficacy findings with qHPV vaccine to 9vHPV vaccine in men aged 16–26 years.

NCT02114385