PMID- 34688944
OWN - NLM
STAT- MEDLINE
DCOM- 20220104
LR  - 20220716
IS  - 1878-3511 (Electronic)
IS  - 1201-9712 (Print)
IS  - 1201-9712 (Linking)
VI  - 114
DP  - 2022 Jan
TI  - Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in 
      Japan: a double-blind, randomized controlled phase 1/2 trial.
PG  - 165-174
LID - S1201-9712(21)00818-3 [pii]
LID - 10.1016/j.ijid.2021.10.030 [doi]
AB  - 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.
CI  - Copyright (c) 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.
FAU - Asano, Michiko
AU  - Asano M
AD  - Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Tokyo, Japan. Electronic 
      address: michiko.asano@astrazeneca.com.
FAU - Okada, Hiroshi
AU  - Okada H
AD  - Medical Science, BioPharmaceuticals, R&D, AstraZeneca, Osaka, Japan.
FAU - Itoh, Yohji
AU  - Itoh Y
AD  - Science and Data Analytics, Oncology R&D, AstraZeneca, Osaka, Japan.
FAU - Hirata, Hajime
AU  - Hirata H
AD  - Clinical Science, BioPharmaceuticals, R&D, AstraZeneca, Osaka, Japan.
FAU - Ishikawa, Kensuke
AU  - Ishikawa K
AD  - Science and Data Analytics, R&D, AstraZeneca, Osaka, Japan.
FAU - Yoshida, Erika
AU  - Yoshida E
AD  - Biopharma Clinical Operations, Development Operations, BioPharmaceuticals R&D, 
      AstraZeneca, Tokyo, Japan.
FAU - Matsui, Akiko
AU  - Matsui A
AD  - Science and Data Analytics, R&D, AstraZeneca, Osaka, Japan.
FAU - Kelly, Elizabeth J
AU  - Kelly EJ
AD  - Microbial Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
FAU - Shoemaker, Kathryn
AU  - Shoemaker K
AD  - Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, 
      MD, USA.
FAU - Olsson, Urban
AU  - Olsson U
AD  - Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, 
      Sweden.
FAU - Vekemans, Johan
AU  - Vekemans J
AD  - Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, 
      Sweden.
LA  - eng
SI  - ClinicalTrials.gov/NCT04568031
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20211022
PL  - Canada
TA  - Int J Infect Dis
JT  - International journal of infectious diseases : IJID : official publication of the 
      International Society for Infectious Diseases
JID - 9610933
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (COVID-19 Vaccines)
RN  - B5S3K2V0G8 (ChAdOx1 nCoV-19)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antibodies, Neutralizing
MH  - Antibodies, Viral
MH  - *COVID-19
MH  - COVID-19 Vaccines
MH  - *ChAdOx1 nCoV-19/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - Japan
MH  - Middle Aged
MH  - SARS-CoV-2
MH  - Young Adult
PMC - PMC8531242
OTO - NOTNLM
OT  - AZD1222
OT  - COVID-19
OT  - ChAdOx1 nCoV-19
OT  - Elderly adult
OT  - Humoral response
OT  - Japan
COIS- Conflict of interest statement JV was an employee and stockholder of AstraZeneca 
      at the time of the study. All other authors are employees of, and hold or may 
      hold stock in, AstraZeneca.
EDAT- 2021/10/25 06:00
MHDA- 2022/01/05 06:00
PMCR- 2021/10/22
CRDT- 2021/10/24 20:38
PHST- 2021/07/28 00:00 [received]
PHST- 2021/09/27 00:00 [revised]
PHST- 2021/10/14 00:00 [accepted]
PHST- 2021/10/25 06:00 [pubmed]
PHST- 2022/01/05 06:00 [medline]
PHST- 2021/10/24 20:38 [entrez]
PHST- 2021/10/22 00:00 [pmc-release]
AID - S1201-9712(21)00818-3 [pii]
AID - 10.1016/j.ijid.2021.10.030 [doi]
PST - ppublish
SO  - Int J Infect Dis. 2022 Jan;114:165-174. doi: 10.1016/j.ijid.2021.10.030. Epub 
      2021 Oct 22.