Evaluation of a primary course of H9N2 vaccine with or without AS03 adjuvant in adults: A phase I/II randomized trial.
Vaccine
; 35(35 Pt B): 4621-4628, 2017 08 16.
Article
de En
| MEDLINE
| ID: mdl-28720281
ABSTRACT
BACKGROUND:
Avian influenza A H9N2 strains have pandemic potential.METHODS:
In this randomized, observer-blind study (ClinicalTrials.gov NCT01659086), 420 healthy adults, 18-64years of age, received 1 of 10 H9N2 inactivated split-virus vaccination regimens (30 participants per group), or saline placebo (120 participants). H9N2 groups received 2 doses (days 0, 21) of 15µg hemagglutinin (HA) without adjuvant, or 1.9µgHA+AS03A, 1.9µgHA+AS03B, 3.75µgHA+AS03A, or 3.75µgHA+AS03B; followed by the same H9N2 formulation or placebo (day 182). AS03 is an adjuvant system containing α-tocopherol (AS03A 11.86mg; AS03B 5.93mg) and squalene in an oil-in-water emulsion. Immunogenicity (hemagglutination inhibition [HI] and microneutralization assays) and safety were assessed up to day 546.RESULTS:
All adjuvanted formulations exceeded regulatory immunogenicity criteria at days 21 and 42 (HI assay), with seroprotection and seroconversion rates of ≥94.9% and ≥89.8% at day 21, and 100% and ≥98.1% at day 42. Immunogenicity criteria were also met for unadjuvanted vaccine, with lower geometric mean titers. In groups administered a third vaccine dose (day 182), an anamnestic immune response was elicited with robust increases in HI and microneutralization titers. Injection site pain was reported more frequently with adjuvanted vaccines. No vaccine-related serious adverse events were observed.CONCLUSIONS:
All H9N2 vaccine formulations were immunogenic with a clinically acceptable safety profile; adjuvanted formulations were 4-8 times dose-sparing (3.75-1.9vs 15µgHA). TRIAL REGISTRATION Registered on ClinicalTrials.gov NCT01659086.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Squalène
/
Vaccins antigrippaux
/
Adjuvants immunologiques
/
Alpha-Tocophérol
/
Sous-type H9N2 du virus de la grippe A
/
Immunogénicité des vaccins
Type d'étude:
Clinical_trials
Limites:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Langue:
En
Journal:
Vaccine
Année:
2017
Type de document:
Article