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
Multicenter / India |
Follow-up duration (months): 2
|BECOV2 (n = 1820)
ChAdOx1 (n = 320)
2 IM doses of 25 mcg BECOV2, 28 days apart
2 IM doses of ChAdOx1 (5 × 10^10 virus particles), 28 days apart
|Characteristics of participants|
Type of participants: Adults
Pregnant women: 0
Immunocompromized patients: 0
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.
|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).
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|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.|