Long-term persistence of immune response to the AS04-adjuvanted HPV-16/18 vaccine in Chinese girls aged 9-17 years: Results from an 8-9-year follow-up phase III open-label study.
AS04-adjuvanted HPV-16/18 vaccine
China
cervical cancer
human papillomavirus
immunogenicity
Journal
Asia-Pacific journal of clinical oncology
ISSN: 1743-7563
Titre abrégé: Asia Pac J Clin Oncol
Pays: Australia
ID NLM: 101241430
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
12
09
2019
accepted:
21
05
2020
pubmed:
12
8
2020
medline:
6
1
2021
entrez:
12
8
2020
Statut:
ppublish
Résumé
In 9-17-year-old Chinese girls, the AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18) given as three-dose schedule induced high antibody levels, which were noninferior 1 month after the third dose to those observed in 18-25-year-old Chinese women in a large efficacy study. We assessed the persistence of antibodies 8-9 years after vaccination in the same subjects. This follow-up phase III, open-label study (NCT03355820) included subjects who had received three doses of AS04-HPV-16/18 in the initial trial (NCT00996125). Serum antibody concentrations were assessed by ELISA and compared to antibody persistence observed in 18-25-year-old Chinese women 6 years after first vaccination in the efficacy study (NCT00779766). Out of the 227 enrolled subjects, 223 were included in the per-protocol immunogenicity analysis. Mean interval from first AS04-HPV-16/18 dose to blood sampling was 101.4 months (8.5 years). For antibodies against HPV-16 and -18, 8.5 years after first vaccine dose all subjects remained seropositive and antibody. Geometric mean concentrations (GMCs) were 1236.3 (95% confidence interval [CI]: 1121.8; 1362.4) and 535.6 (95% CI: 478.6; 599.4) ELISA Units/mL, respectively. These seropositivity rates and antibody GMCs were higher than those observed 6 years after first vaccination of 18-25-year-old women. Sustained anti-HPV-16 and -18 immune responses were observed 8-9 years after AS04-HPV-16/18 vaccination of 9-17 year-old Chinese girls that were higher than the ones observed 6 years after first vaccination in Chinese adult women in whom AS04-HPV-16/18 efficacy against cervical intraepithelial neoplasia of grade ≥2 was demonstrated.
Identifiants
pubmed: 32780946
doi: 10.1111/ajco.13398
pmc: PMC7754390
doi:
Substances chimiques
Papillomavirus Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT00779766']
Types de publication
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
392-399Subventions
Organisme : GlaxoSmithKline Biologicals SA
Informations de copyright
© 2020 The Authors. Asia-Pacific Journal of Clinical Oncology published by John Wiley & Sons Australia, Ltd.
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