Trial TCTR20210731003
Publication Tawinprai K, Expert Rev Vaccines, 2022
Dates: 2021-08-09 to 2021-08-13
Funding: Public/non profit (Chulabhorn Royal Academy and National Vaccine Institute)
Conflict of interest: no COI

Methods
RCT
Location : Single center / Thailand
Follow-up duration (months): 0.5
BBIBP-CorV (n=40)
ChAdOx1 (n=41)
Inclusion criteria
  • 18 years or older
  • completed two doses of CoronaVac at least 2 months and not longer than 4 months before enrollment
  • No history of a severe allergic reaction to the prior vaccine
  • No fever nor history of fever within 14 days
  • No symptoms of respiratory tract infection within 14 days
  • sign informed consent to the study.
Exclusion criteria
  • Pregnancy
  • lactation
  • concurrent active underlying disease
  • receiving any vaccine within 14 days before enrollment
  • fever or respiratory tract infection within 14 days of enrollment
  • known history of COVID-19.
Interventions
Intervention
1 IM dose of 5 x 10^10 vp AZD1222 (booster), 2-4 months after 2 prime doses of CoronaVac.
Control
1 IM dose of 4 mcg BBIBP-CorV (booster), 2-4 months after 2 prime doses of CoronaVac.
Participants
Randomized
81 participants
Characteristics of participants
Type of participants: Adults without active underlying disease
N=81
42 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Adults, including elderly, without active underlying disease and with no history of COVID-19, who completed 2 doses of CoronaVac, in a single centre in Thailand.
Primary outcome
In the register
Outcome Name: Humoral immunity 2 weeks after third dose; Metric / Method of measurement: Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2; Time point: 2 weeks after the third dose of the vaccine
In the report
Ratio of the geometric mean concentration (GMR) of the total anti-RBD antibody concentration post-vaccination compared with that pre-vaccination in each vaccine group.
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: No
Data accessibility: From registry: No Plan to share IPD. Corresponding author: Kriangkrai Tawinprai Email: Kriangkrai.taw@cra.ac.th
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
Some concerns
General comment In addition to the published article, the study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The target sample size specified in the registry (n=80) was achieved (n=81).