Trial NCT04568031
Publication Asano M, Int J Infect Dis, 2021
Dates: 2020-08-01 to 2021-02-24
Funding: Private (AstraZeneca)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / Japan
Follow-up duration (months): 1.9
ChAdOx1-S (n=192)
Placebo (n=64)
Inclusion criteria
  • Adults aged ≥18 years
  • seronegative to SARS-CoV-2 at screening
  • negative reverse-transcriptase polymerase chain reaction test for SARS-CoV-2
  • mild/moderate, well-controlled comorbidities were allowed
Exclusion criteria
  • history of laboratory-confirmed SARS-CoV-2 infection
  • pregnant women
  • a new onset of fever
  • any confirmed or suspected immunodeficient state
  • receipt of any vaccine within 30 days before and after each study dose
  • or prior or planned receipt of an investigational or licensed vaccine or product that may impact interpretation of trial data (e.g., adenovirus-vectored vaccines or coronavirus vaccines)
  • severe and/or uncontrolled cardiovascular, respiratory, gastrointestinal, hepatic, or renal disease, endocrine disorder, or neurologic illness
Interventions
Intervention
2 IM doses of 5 × 10^10 vp ChAdOx1, 28 days apart
Control
2 IM doses of saline placebo, 28 days apart
Participants
Randomized
256 participants
Characteristics of participants
Type of participants: Adults
N=256
169 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Adults with or without mild, well-controlled co-morbidities seronegative and PCR negative to SARS-CoV-2 at 5 centres in Japan
Primary outcome
In the register
1) Proportion of participants who have a post treatment seroresponse to the spike antigens of AZD1222 [ Time Frame: Day 57 ]; 2) The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination [ Time Frame: Day 1 to 8 ]; 3) The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination [ Time Frame: Day 29 to 36 ]; 4) The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) [ Time Frame: Day 1 through Day 57 ]; 5) Biochemistry; change from baseline for blood chemistry measures [ Time Frame: Day 8, Day 29, Day 36, and Day 57 ]; 6) Haematology; change from baseline for hematology/hemostasis measures [ Time Frame: Day 8, Day 29, Day 36, and Day 57 ]
In the report
1) Immunogenicity, measured by anti-SARS-CoV-2 spike seroresponse (≥4-fold rise in titers from Day 1 baseline value) at Day 57; 2) Safety, measured by occurrence of solicited local and systemic reactogenicity signs/symptoms in the 6 days after each dose; occurrence of unsolicited AEs, serious AEs (SAEs), and AEs of special interest (AESIs) for 28 days after each dose; and change from baseline in safety laboratory measures
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes
Data accessibility: Data underlying the findings described in this manuscript may be requested in accordance with AstraZeneca's data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Corresponding author: Michiko Asano, michiko.asano@astrazeneca.com
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Low
General comment In addition to the published article, the study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The target sample size specified in the registry was achieved. There is no change from the trial registration in the intervention and control groups. Immunogenicity outcomes: GMTs for specific antibody was not reported and GMTs for neutralizing antibody was not fully reported. The present article reports on immunogenicity and satefy outcomes up to day 57, the study is planned for a 1 year follow-up.