Table 3.
Humoral immune response induced by a single dose of FINLAY-FR-1A vaccine
|
FINLAY-FR-1A vaccine group (n=358) |
Vaccine excipient group (n=81) |
Cuban Convalescent Serum Panel (n=68) | |||
|---|---|---|---|---|---|
| Prevaccination | 28 days post-vaccination | Prevaccination | 28 days post-vaccination | ||
| Anti-RBD IgG U/mL | |||||
| Median | 9·7 | 301·0 | 10·2 | 6·6 | 50·8 |
| 25–75 percentile | 3·0–28·8 | 103·0–819·2 | 2·5–25·7 | 1·9–17·1 | 23·8–94·0 |
| Anti-RBD IgG seroconversion | |||||
| n (%) | NA | 302 (84%) | NA | 0 | NA |
| 95% CI | NA | 80–88 | NA | 0–1 | NA |
| RBD:hACE2 inhibition % | |||||
| Median | 11 | 94 | 12 | 13 | 32 |
| 25–75 percentile | 4–27 | 89–95 | 5–26 | 6–22 | 17–62 |
| sVNT50 | |||||
| GMT | 17·4 | 884·0 | 20·1 | 19·6 | 41·8 |
| 95% CI | 15·0–20·1 | 682·1–1145·7 | 14·8–27·4 | 13·3–28·8 | 27·7–63·2 |
| sVNT50≥250 | |||||
| n (%) | 13 (4%) | 289 (81)% | 6 (7%) | 4 (5%) | 9 (13%) |
| 95% CI | 2–6 | 76–85 | 3–15 | 1–12 | 6–24 |
| cVNT* | |||||
| GMT | 15·4 | 400·3 | NA | NA | 46·4 |
| 95% CI | 10·3–23·2 | 272·4–588·1 | NA | NA | 31·5–68·4 |
RBD=receptor binding domain.
*
Evaluated in 57 participants. Anti-RBD IgG seroconversion=≥4-times increase in antibody titres over pre-immunisation titres. RBD:hACE2 inhibition %=RBD:hACE2 inhibition % at a dilution 1/100. sVNT50=serum dilution inhibiting 50% of RBD:hACE2 interaction. sVNT50 ≥250=successful immune response. cVNT=conventional live-virus neutralisation titre. GMT=geometric mean titre. NA=not applicable. RBD=receptor binding domain. sVNT50=half-maximal surrogate virus neutralisation titre.