Elsevier

Vaccine

Volume 34, Issue 35, 29 July 2016, Pages 4205-4212
Vaccine

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

https://doi.org/10.1016/j.vaccine.2016.06.056Get rights and content
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open access

Abstract

Background

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

Abbreviations

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

Keywords

Human papilloma virus
Anogenital cancers
Anogenital warts
Immunogenicity
Safety
Nine-valent human papilloma virus vaccine

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