Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial
| Autor: | Kensuke Ishikawa, Yohji Itoh, Elizabeth J. Kelly, Erika Yoshida, Michiko Asano, Johan Vekemans, Hiroshi Okada, Kathryn Shoemaker, Hajime Hirata, Urban Olsson, Akiko Matsui |
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| Rok vydání: | 2021 |
| Předmět: |
Microbiology (medical)
Adult medicine.medical_specialty COVID-19 Vaccines Adolescent Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Infectious and parasitic diseases RC109-216 Placebo Antibodies Viral Article Malaise Double blind Young Adult Double-Blind Method Japan AZD1222 elderly adult Multicenter trial Internal medicine ChAdOx1 nCoV-19 medicine Humans Adverse effect Aged business.industry SARS-CoV-2 Immunogenicity COVID-19 General Medicine Middle Aged Antibodies Neutralizing Tenderness Infectious Diseases medicine.symptom business humoral response |
| Zdroj: | International Journal of Infectious Diseases International Journal of Infectious Diseases, Vol 114, Iss, Pp 165-174 (2022) |
| ISSN: | 1878-3511 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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