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Cancer Med. 2017 Nov;6(11):2723-2731. doi: 10.1002/cam4.1155. Epub 2017 Oct 5.

Ten-year immune persistence and safety of the HPV-16/18 AS04-adjuvanted vaccine in females vaccinated at 15-55 years of age.

Author information

1
Central Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg, Germany.
2
NZOZ Vitamed, Bydgoszcz, Poland.
3
Faculty of Medicine and Health Sciences, University of Zielona Gora, Zielona Gora, Poland.
4
Department of Preventive Medicine, Poznan University of Medical Sciences, Poznan, Poland.
5
Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
6
GSK, Rixensart, Belgium.
7
GSK, Bangalore, India.
8
GSK, Wavre, Belgium.

Abstract

Women remain at risk of human papillomavirus (HPV) infection for most of their lives. The duration of protection against HPV-16/18 from prophylactic vaccination remains unknown. We investigated the 10-year immune response and long-term safety profile of the HPV-16/18 AS04-adjuvanted vaccine (AS04-HPV-16/18 vaccine) in females aged between 15 and 55 years at first vaccination. Females who received primary vaccination with three doses of AS04-HPV-16/18 vaccine in the primary phase-III study (NCT00196937) were invited to attend annual evaluations for long-term immunogenicity and safety. Anti-HPV-16/18 antibodies in serum and cervico-vaginal secretions (CVS) were measured using enzyme-linked immunosorbent assay (ELISA). Serious adverse events (SAEs) were recorded throughout the follow-up period. Seropositivity rates for anti-HPV-16 remained high (≥96.3%) in all age groups 10 years after first vaccination. It was found that 99.2% of 15-25-year olds remained seropositive for anti-HPV-18 compared to 93.7% and 83.8% of 26-45-year olds and 45-55-year olds, respectively. Geometric mean titers (GMT) remained above natural infection levels in all age groups. Anti-HPV-16 and anti-HPV-18 titers were at least 5.3-fold and 3.1-fold higher than titers observed after natural infection, respectively, and were predicted to persist above natural infection levels for ≥30 years in all age groups. At Year 10, anti-HPV-16/18 antibody titers in subjects aged 15-25 years remained above plateau levels observed in previous studies. Correlation coefficients for antibody titers in serum and CVS were 0.64 (anti-HPV-16) and 0.38 (anti-HPV-18). This study concluded that vaccinated females aged 15-55 years elicited sustained immunogenicity with an acceptable safety profile up to 10 years after primary vaccination, suggesting long-term protection against HPV.

KEYWORDS:

AS04-HPV-16/18 vaccine; older women; persistence; safety

PMID:
28984053
PMCID:
PMC5673947
DOI:
10.1002/cam4.1155
[Indexed for MEDLINE]
Free PMC Article

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