Trial CTRI/2021/08/036074
Publication Thuluva , medRxiv, 2022

Funding: Public/non profit (BIRAC-division of Department of Biotechnology, Government of India; the Coalition for Epidemic Preparedness Innovations.)
Conflict of interest: no COI

Methods
RCT
Location : Multicenter / India
Follow-up duration (months): 2
BECOV2 (n = 1820)
ChAdOx1 (n = 320)
Inclusion criteria
  • Healthy adults
  • aged between 18 to 80 years
  • seronegative to anti-SARS-CoV-2 IgG antibody prior to randomization (immunogenicity arm), or irrespective of serostatus (safety arm)
  • virologically negative to SARS-CoV-2 infection confirmed by RT-PCR test
  • seronegative to HIV 1 & 2, HBV and HCV infection.
Exclusion criteria
  • Axillary temperature of more than 38·0°C
  • part of any other clinical trial
  • with a history of vaccination with any investigational vaccine against Covid-19 disease
  • known allergy to vaccine components
  • pregnancy
  • on immunosuppressants, immunodeficient.
Interventions
Intervention
2 IM doses of 25 mcg BECOV2, 28 days apart
Control
2 IM doses of ChAdOx1 (5 × 10^10 virus particles), 28 days apart
Participants
Randomized
2140 participants
Characteristics of participants
Type of participants: Adults
N=2140
1525 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 18-79
Description of participants
Healthy adults without a history of Covid-19 vaccination or SARS-CoV-2 infection at 20 centers in India.
Primary outcome
In the register
Immune response measured after completion of 2-dose immunization schedule, as determined by geometric mean titres (GMT/C) of SARS-CoV-2 specific neutralising antibodies to evaluate immunogenic superiority. After 14 days.
In the report
GMTs of anti-SARS-CoV-2 virus neutralizing antibodies at day 42 (14 days after 2nd dose).
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes
Data accessibility: Additional study data which is not part of the manuscript can be made available upon request and addressed to the corresponding author Dr. Subhash Thuluva at his email subhash.thuluva@biologicale.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
Some concerns
General comment In addition to the pre-print article, the registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article reflects that in the registry. It is not clear whether the trial (n = 2140) achieved a predetermined sample size. This is a preliminary analysis and the study follow up is ongoing.