Table 1.
Demographic characteristics of participants in the safety population (N=25 753)
| BBV152 (N=12 879) | Placebo (N=12 874) | ||
|---|---|---|---|
| Age, years | 40·1 (13·8) | 40·1 (14·1) | |
| Range | 18–92 | 19–97 | |
| Sex | |||
| Female | 4214 (32·7%) | 4254 (33·0%) | |
| Male | 8665 (67·3%) | 8620 (66·9%) | |
| BMI, kg/m2 | 24·3 (4·4) | 24·3 (4·3) | |
| Pre-existing medical conditions | |||
| Stable cardiovascular disease | 557 (4·3%) | 523 (4·1%) | |
| Stable respiratory disease | 126 (1·0%) | 170 (1·3%) | |
| Controlled diabetes | 706 (5·5%) | 735 (5·7%) | |
| Stable liver disease | 25 (0·2%) | 28 (0·2%) | |
| Severe obesity (BMI >35 kg/m2) | 56 (0·4%) | 94 (0·7%) | |
| Other stable comorbidities | 839 (6·5%) | 910 (7·1%) | |
| Multiple risk categories | 458 (3·6%) | 497 (3·9%) | |
| Baseline assessments for SARS-CoV-2 positivity* | |||
| Positive for anti-SARS-CoV-2 IgG | 3932 (30·5%) | 3886 (30·2%) | |
| Positive for SARS-CoV-2 by PCR | 108 (0·8%) | 105 (0·8%) | |
Data are mean (SD) or n (%) unless otherwise stated. BMI=body-mass index.
*
At the screening and first vaccination visit (day 0, visit 1) participants were evaluated for exposure to SARS-CoV-2 with both anti-SARS-CoV-2 IgG by ELISA and RT-PCR. Regardless of the outcome of these tests, participants were randomly assigned and received the first dose of vaccine or placebo.