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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| Format: | Article |
| Language: | English |
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Elsevier
2022-01-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971221008183 |
| _version_ | 1819172421448499200 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-22T20:06:55Z |
| format | Article |
| id | doaj.art-5a9a99c9026245c48ec517cf46724f79 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-22T20:06:55Z |
| publishDate | 2022-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-5a9a99c9026245c48ec517cf46724f792022-12-21T18:14:06ZengElsevierInternational Journal of Infectious Diseases1201-97122022-01-01114165174Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trialMichiko Asano0Hiroshi Okada1Yohji Itoh2Hajime Hirata3Kensuke Ishikawa4Erika Yoshida5Akiko Matsui6Elizabeth J. Kelly7Kathryn Shoemaker8Urban Olsson9Johan Vekemans10Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Tokyo, Japan; Corresponding author. Address: 3 Chome-1-1 Shibaura, Minato City, Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Tokyo 108-0023, Japan.Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Osaka, JapanScience and Data Analytics, Oncology R&D, AstraZeneca, Osaka, JapanClinical Science, BioPharmaceuticals, R&D, AstraZeneca, Osaka, JapanScience and Data Analytics, R&D, AstraZeneca, Osaka, JapanBiopharma Clinical Operations, Development Operations, BioPharmaceuticals R&D, AstraZeneca, Tokyo, JapanScience and Data Analytics, R&D, AstraZeneca, Osaka, JapanMicrobial Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USARespiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USARespiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, SwedenRespiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, SwedenABSTRACT: 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.http://www.sciencedirect.com/science/article/pii/S1201971221008183COVID-19ChAdOx1 nCoV-19AZD1222JapanElderly adultHumoral response |
| spellingShingle | 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 International Journal of Infectious Diseases COVID-19 ChAdOx1 nCoV-19 AZD1222 Japan Elderly adult Humoral response |
| 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_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_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_sort | immunogenicity and safety of azd1222 chadox1 ncov 19 against sars cov 2 in japan a double blind randomized controlled phase 1 2 trial |
| topic | COVID-19 ChAdOx1 nCoV-19 AZD1222 Japan Elderly adult Humoral response |
| url | http://www.sciencedirect.com/science/article/pii/S1201971221008183 |
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