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Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial.
Asano, Michiko; Okada, Hiroshi; Itoh, Yohji; Hirata, Hajime; Ishikawa, Kensuke; Yoshida, Erika; Matsui, Akiko; Kelly, Elizabeth J; Shoemaker, Kathryn; Olsson, Urban; Vekemans, Johan.
  • Asano M; Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Tokyo, Japan. Electronic address: michiko.asano@astrazeneca.com.
  • Okada H; Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Osaka, Japan.
  • Itoh Y; Science and Data Analytics, Oncology R&D, AstraZeneca, Osaka, Japan.
  • Hirata H; Clinical Science, BioPharmaceuticals, R&D, AstraZeneca, Osaka, Japan.
  • Ishikawa K; Science and Data Analytics, R&D, AstraZeneca, Osaka, Japan.
  • Yoshida E; Biopharma Clinical Operations, Development Operations, BioPharmaceuticals R&D, AstraZeneca, Tokyo, Japan.
  • Matsui A; Science and Data Analytics, R&D, AstraZeneca, Osaka, Japan.
  • Kelly EJ; Microbial Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Shoemaker K; Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Olsson U; Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Vekemans J; Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Int J Infect Dis ; 114: 165-174, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1474621
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 31 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / ChAdOx1 nCoV-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Aged / Humans / Middle aged / Young adult Country/Region as subject: Asia Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / ChAdOx1 nCoV-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Aged / Humans / Middle aged / Young adult Country/Region as subject: Asia Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article