One year safety and immunogenicity of AZD1222 (ChAdOx1 nCoV-19): Final analysis of a randomized, placebo-controlled phase 1/2 trial in Japan.
Vaccine
; 41(29): 4199-4205, 2023 06 29.
Article
en En
| MEDLINE
| ID: mdl-37271703
ABSTRACT
BACKGROUND:
Long duration trial data for two-dose COVID-19 vaccines primary series' are uncommon due to unblinding and additional doses. We report one-year follow-up results from a phase 1/2 trial of AZD1222 (ChAdOx1 nCoV-19) in Japan.METHODS:
Adults (n = 256) seronegative for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were stratified by age, 18-55 (n = 128), 56-69 (n = 86) and ≥70-year-old (n = 42), and randomized 31 to AZD1222 or placebo. Safety, immunogenicity, and exploratory efficacy data were collected until study Day 365.RESULTS:
Safety was consistent with previous reports. In AZD1222 vaccinees, humoral responses against SARS-CoV-2 steadily declined over time. By Day 365, anti-SARS-CoV-2 spike-binding (spike) and receptor-binding domain (RBD) mean antibody titers remained above Day 15 levels and pseudovirus neutralizing antibodies were undetectable in many participants.CONCLUSIONS:
AZD1222 is immunogenic and well tolerated in Japanese adults. Expected waning in anti-SARS-CoV-2 humoral responses was observed; spike and RBD antibody titers remained elevated. (ClinicalTrials.gov NCT04568031).Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
COVID-19
/
ChAdOx1 nCoV-19
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
/
Adult
/
Aged
/
Humans
/
Middle aged
País/Región como asunto:
Asia
Idioma:
En
Revista:
Vaccine
Año:
2023
Tipo del documento:
Article
País de afiliación:
Japón