Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial
ABSTRACT: Background: Immunogenicity and safety of the AZD1222 (ChAdOx1 nCoV-19) vaccine was evaluated in Japanese adults in an ongoing phase 1/2, randomized, double-blind, parallel-group, placebo-controlled, multi-centre trial (NCT04568031). Methods: Adults (n=256, age ≥18 years) seronegative for...
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Elsevier
2022
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oai:doaj.org-article:5a9a99c9026245c48ec517cf46724f792021-12-04T04:33:19ZImmunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial1201-971210.1016/j.ijid.2021.10.030https://doaj.org/article/5a9a99c9026245c48ec517cf46724f792022-01-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S1201971221008183https://doaj.org/toc/1201-9712ABSTRACT: Background: Immunogenicity and safety of the AZD1222 (ChAdOx1 nCoV-19) vaccine was evaluated in Japanese adults in an ongoing phase 1/2, randomized, double-blind, parallel-group, placebo-controlled, multi-centre trial (NCT04568031). Methods: Adults (n=256, age ≥18 years) seronegative for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were stratified by age into 18–55- (n=128), 56–69- (n=86) and ≥70-year-old cohorts (n=42), and randomized 3:1 to receive AZD1222 or placebo (two intramuscular injections 4 weeks apart). Immunogenicity and safety were coprimary endpoints. Data collected up to Day 57 are reported. Results: Positive seroresponses to SARS-CoV-2 spike and receptor-binding domain antigens were seen in all 174 participants who received two doses of AZD1222. Neutralizing antibody seroresponses were seen in 67.5%, 60.3% and 50.0% of participants receiving AZD1222 aged 18–55, 56–69 and ≥70 years, respectively. Solicited adverse events (AEs) were typically mild/moderate in severity and included pain and tenderness at the injection site, malaise, fatigue, muscle pain and headache. Common unsolicited AEs included pain and tenderness at the injection site, fatigue and elevated body temperature. No vaccine-related serious AEs or deaths were reported. Conclusions: AZD1222 elicited a strong humoral immune response against SARS-CoV-2, and was well tolerated in Japanese participants, including elderly participants.Michiko AsanoHiroshi OkadaYohji ItohHajime HirataKensuke IshikawaErika YoshidaAkiko MatsuiElizabeth J. KellyKathryn ShoemakerUrban OlssonJohan VekemansElsevierarticleCOVID-19ChAdOx1 nCoV-19AZD1222JapanElderly adultHumoral responseInfectious and parasitic diseasesRC109-216ENInternational Journal of Infectious Diseases, Vol 114, Iss , Pp 165-174 (2022) |
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DOAJ |
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DOAJ |
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EN |
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COVID-19 ChAdOx1 nCoV-19 AZD1222 Japan Elderly adult Humoral response Infectious and parasitic diseases RC109-216 |
| spellingShingle |
COVID-19 ChAdOx1 nCoV-19 AZD1222 Japan Elderly adult Humoral response Infectious and parasitic diseases RC109-216 Michiko Asano Hiroshi Okada Yohji Itoh Hajime Hirata Kensuke Ishikawa Erika Yoshida Akiko Matsui Elizabeth J. Kelly Kathryn Shoemaker Urban Olsson Johan Vekemans Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial |
| description |
ABSTRACT: Background: Immunogenicity and safety of the AZD1222 (ChAdOx1 nCoV-19) vaccine was evaluated in Japanese adults in an ongoing phase 1/2, randomized, double-blind, parallel-group, placebo-controlled, multi-centre trial (NCT04568031). Methods: Adults (n=256, age ≥18 years) seronegative for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were stratified by age into 18–55- (n=128), 56–69- (n=86) and ≥70-year-old cohorts (n=42), and randomized 3:1 to receive AZD1222 or placebo (two intramuscular injections 4 weeks apart). Immunogenicity and safety were coprimary endpoints. Data collected up to Day 57 are reported. Results: Positive seroresponses to SARS-CoV-2 spike and receptor-binding domain antigens were seen in all 174 participants who received two doses of AZD1222. Neutralizing antibody seroresponses were seen in 67.5%, 60.3% and 50.0% of participants receiving AZD1222 aged 18–55, 56–69 and ≥70 years, respectively. Solicited adverse events (AEs) were typically mild/moderate in severity and included pain and tenderness at the injection site, malaise, fatigue, muscle pain and headache. Common unsolicited AEs included pain and tenderness at the injection site, fatigue and elevated body temperature. No vaccine-related serious AEs or deaths were reported. Conclusions: AZD1222 elicited a strong humoral immune response against SARS-CoV-2, and was well tolerated in Japanese participants, including elderly participants. |
| format |
article |
| author |
Michiko Asano Hiroshi Okada Yohji Itoh Hajime Hirata Kensuke Ishikawa Erika Yoshida Akiko Matsui Elizabeth J. Kelly Kathryn Shoemaker Urban Olsson Johan Vekemans |
| author_facet |
Michiko Asano Hiroshi Okada Yohji Itoh Hajime Hirata Kensuke Ishikawa Erika Yoshida Akiko Matsui Elizabeth J. Kelly Kathryn Shoemaker Urban Olsson Johan Vekemans |
| author_sort |
Michiko Asano |
| title |
Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial |
| title_short |
Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial |
| title_full |
Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial |
| title_fullStr |
Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial |
| title_full_unstemmed |
Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial |
| title_sort |
immunogenicity and safety of azd1222 (chadox1 ncov-19) against sars-cov-2 in japan: a double-blind, randomized controlled phase 1/2 trial |
| publisher |
Elsevier |
| publishDate |
2022 |
| url |
https://doaj.org/article/5a9a99c9026245c48ec517cf46724f79 |
| work_keys_str_mv |
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