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Vaccine. 2015 Nov 27;33(48):6855-64. doi: 10.1016/j.vaccine.2015.08.059. Epub 2015 Sep 26.

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine.

Author information

1
Department of Microbiology and Infectious Diseases, Royal Women's Hospital, Parkville, Victoria, Australia; Department of Microbiology, Royal Children's Hospital, Murdoch Childrens Research Institute, Parkville, Victoria, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia. Electronic address: suzanne.garland@thewomens.org.au.
2
Department of Obstetrics and Gynaecology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong Special Administrative Region.
3
Canadian Center for Vaccinology, Izaak Walton Killam Health Centre and Capital Health, Dalhousie University, Canada.
4
Department of Gynecology, University Hospital of Aarhus, Denmark.
5
Department of Obstetrics and Gynecology, University of Puerto Rico School of Medicine, Puerto Rico.
6
Asociacion de Investigación Pediatrica y Adultos (AINPAD A.C.)/StarMedica Morelia, Mexico.
7
Merck & Co., Inc., Kenilworth, NJ, USA.

Abstract

OBJECTIVES:

To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.

METHODS:

V503-006 was a randomized, double-blinded, safety/tolerability and immunogenicity study of the 9vHPV vaccine in females 12-26 years of age who were previously vaccinated with qHPV vaccine. Subjects were randomized in a 2:1 ratio to receive 3 doses of 9vHPV vaccine (n=618) or saline placebo (n=306) at day 1, month 2, and month 6. Systemic, injection-site and serious adverse experiences (AEs) were monitored. Serum samples were collected at day 1, month 2, and month 7. Anti-HPV 6/11/16/18/31/33/45/52/58 titers were measured using the 9-valent HPV competitive Luminex Immunoassay (cLIA).

RESULTS:

The frequency of injection-site AEs (days 1-5 following any vaccination) was higher in the 9vHPV vaccine group than in the placebo group (91.1% and 43.9%, respectively). The frequencies of vaccine-related systemic AEs (days 1-15 following any vaccination) were generally comparable between the 2 groups (30.6% in the 9vHPV vaccine group, and 25.9% in the placebo group). One vaccine-related serious AE was reported in each of the 9vHPV vaccine and placebo groups. Few subjects (9vHPV=0.5%; placebo=0%) discontinued due to an AE. At 4 weeks post-dose 3, over 98% of subjects in the 9vHPV vaccine group were seropositive for HPV types 31/33/45/52/58, with marked elevations in cLIA geometric mean titers (GMTs) to these HPV types. Anti-HPV 31/33/45/52/58 GMTs were lower than in subjects administered 9vHPV vaccine who had not previously received qHPV vaccine (based on cross-study analyses); the clinical significance of this difference is unknown.

CONCLUSIONS:

Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01047345.

KEYWORDS:

9-Valent; GARDASIL; HPV; Immunogenicity; Safety; Vaccine

PMID:
26411885
DOI:
10.1016/j.vaccine.2015.08.059
[Indexed for MEDLINE]

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