Methods:

Study design and participants

Randomised double-blind, multicentre (11 hospitals across 9 states of India), phase 1 trial to assess

• Safety
• Reactogenicity
• Tolerability
• Immunogenicity

of the BBV152 vaccine in healthy adult volunteers.

Participants were apparently healthy adults aged between 18-55 years at the time of enrolment.

Eligibility for participation in the trial was assessed by

• Medical history
• Physical examination
• Laboratory findings (haematology, biochemistry, urine tests).

Participants were initially screened (for SARS-CoV-2) by testing with

• TRUPCR SARS-CoV-2 RT-PCR
• LIAISON SARS-CoV-2 S1/S2 IgG (serology)

and excluded from the trial if positive for any one test or had

• an axillary temperature of >37.0 C
• known allergy to any vaccine component.

The trial was approved by the National Regulatory Authority of India and registered at ClinicalTrials.gov (NCT04471519).

The median time between screening visit and vaccination visit was 4 days (range 3-6 days).