Trial TCTR20210720007
Publication Niyomnaitham S, Hum Vaccin Immunother, 2022
Dates: 2021-01-01 to 2021-06-30
Funding: No specific funding (The author(s) reported there is no funding associated with the work featured in this article. Registry: National Research Council of Thailand)
Conflict of interest: no COI

Methods
RCT
Location : Single center / Thailand
Follow-up duration (months): 2.8
BNT162b2-BNT162b2 (n = 30)
CoronaVac-ChAdOx1 (n = 30)
CoronaVac-BNT162b2 (n = 30)
ChAdOx1-CoronaVac (n = 30)
ChAdOx1-BNT162b2 (n = 30)
BNT162b2-CoronaVac (n = 30)
BNT162b2-ChAdOx1 (n = 30)
Inclusion criteria
  • Healthy adults
  • aged 18–60 years
  • not known to be infected with SARS-CoV-2
  • not received any COVID-19 vaccine prior to this study. healthy
  • adults aged 18–60 years
  • who were not known to be infected with SARS-CoV-2
  • have not received any COVID-19 vaccine prior to this study
  • Males or females
  • Can understand Thai language through speaking, reading and writing
  • Able to communicate through electronic tools such as Google form or line
  • Capable of attending all study visits according to the study schedule
  • Capable of informed consent and provision of written informed consent before any study procedures.
Exclusion criteria
  • Unstable underlying disease
  • having acute illness
  • had a history of anaphylaxis
  • pregnant females
  • immunocompromised or receiving immunosuppressants at screening
  • had a positive SAR-CoV-2 antinucleoprotein (anti-NP) or anti-RBD IgG antibody at baseline (detected COVID-19 infection)
  • Have history of COVID-19 high risk contact
  • Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies within the last 90 days
  • Have history of cigarettes smoking, alcohol drinking and history of drug abuse
  • Have any unusual symptoms or medical history that considered unable to participate in the study.
Interventions
Intervention
1 IM dose of CoronaVac, 1 IM dose of ChAdOx1, 28 days apart
1 IM dose of CoronaVac, 1 IM dose of BNT162b2, 28 days apart
1 IM dose of ChAdOx1, 1 IM dose of CoronaVac, 28 days apart
1 IM dose of ChAdOx1, 1 IM dose of BNT162b2, 28 days apart
1 IM dose of BNT162b2, 1 IM dose of CoronaVac, 28 days apart
1 IM dose of BNT162b2, 1 IM dose of ChAdOx1, 28 days apart
Control
2 IM doses of BNT162b2, 28 days apart
Participants
Randomized
210 participants
Characteristics of participants
Type of participants: Adults
N=210
102 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Adults including healthy or stable co-morbidities that were SARS-CoV-2 infection-free in a single centre in Thailand.
Primary outcome
In the register
Adverse events 7 days after Vaccination and up to 12 weeks after 2nd dose or 2 weeks after 3rd dose
In the report
A sample size of 30 per group would give 0.9 power to determine the significant difference in anti-RBD IgG based on a previous study of homologous CoronaVac and ChAdOx1
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes
Data accessibility: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. Contact: Kulkanya Chokephaibulkit kulkanya.cho@mahidol.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 and its supplement, the study registry was used in data extraction and risk of bias assessment. The target sample size (N=270) specified in the registry was not achieved. There is no change from the trial registration in the intervention and control treatments. Results were extracted after 2nd vaccination dose (not after 1st dose or booster, which are also reported in the publication).