tetano
Editor, Senior Moderator
Vaccine
. 2023 Jun 2;S0264-410X(23)00542-X.
doi: 10.1016/j.vaccine.2023.05.015. Online ahead of print. One year safety and immunogenicity of AZD1222 (ChAdOx1 nCoV-19): Final analysis of a randomized, placebo-controlled phase 1/2 trial in Japan
Kensuke Ishikawa[SUP] 1 [/SUP], Maria-Claudia Nascimento[SUP] 2 [/SUP], Michiko Asano[SUP] 3 [/SUP], Hajime Hirata[SUP] 4 [/SUP], Yohji Itoh[SUP] 5 [/SUP], Elizabeth J Kelly[SUP] 6 [/SUP], Akiko Matsui[SUP] 1 [/SUP], Urban Olsson[SUP] 7 [/SUP], Kathryn Shoemaker[SUP] 8 [/SUP], Justin Green[SUP] 9 [/SUP]
Affiliations
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 3:1 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).
Keywords: AZD1222; COVID-19; ChAdOx1 nCoV-19; Humoral response; Japan; Vaccine.
. 2023 Jun 2;S0264-410X(23)00542-X.
doi: 10.1016/j.vaccine.2023.05.015. Online ahead of print. One year safety and immunogenicity of AZD1222 (ChAdOx1 nCoV-19): Final analysis of a randomized, placebo-controlled phase 1/2 trial in Japan
Kensuke Ishikawa[SUP] 1 [/SUP], Maria-Claudia Nascimento[SUP] 2 [/SUP], Michiko Asano[SUP] 3 [/SUP], Hajime Hirata[SUP] 4 [/SUP], Yohji Itoh[SUP] 5 [/SUP], Elizabeth J Kelly[SUP] 6 [/SUP], Akiko Matsui[SUP] 1 [/SUP], Urban Olsson[SUP] 7 [/SUP], Kathryn Shoemaker[SUP] 8 [/SUP], Justin Green[SUP] 9 [/SUP]
Affiliations
- PMID: 37271703
- DOI: 10.1016/j.vaccine.2023.05.015
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 3:1 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).
Keywords: AZD1222; COVID-19; ChAdOx1 nCoV-19; Humoral response; Japan; Vaccine.