Table 2.
3 μg group | 6 μg group | Placebo group | p value* | |||
---|---|---|---|---|---|---|
Phase 1 | ||||||
Days 0 and 14 vaccination cohort | ||||||
Neutralising antibodies to live SARS-CoV-2 | ||||||
Day 14 | 11/24 (45·8%; 25·6–67·2) | 12/24 (50·0%; 29·1–70·9) | 0/24 (0·0%; 0·0–14·3) | 0·77 | ||
Day 28 | 6/24 (25·0%; 9·8–46·7) | 20/24 (83·3%; 62·6–95·3) | 0/24 (0·0%; 0·0–14·3) | <0·0001 | ||
RBD-IgG | ||||||
Day 14 | 20/24 (83·3%; 62·6–95·3) | 24/24 (100%; 85·8–100) | 2/24 (8·3%; 1·0–27·0) | 0·11 | ||
Day 28 | 21/24 (87·5%; 67·6–97·3) | 24/24 (100%; 85·8–100) | 2/24 (8·3%; 1·0–27·0) | 0·23 | ||
Days 0 and 28 vaccination cohort | ||||||
Neutralising antibodies to live SARS-CoV-2 | ||||||
Day 14 | 19/24 (79·2%; 57·9–92·9) | 20/24 (83·3%; 62·6–95·3) | 0/23 (0·0%; 0·0–14·8) | 1·00 | ||
Day 28 | 20/24 (83·3%; 62·6–95·3) | 19/24 (79·2%; 57·9–92·9) | 1/23 (4·4%; 0·1–22·0) | 1·00 | ||
RBD-IgG | ||||||
Day 14 | 24/24 (100%; 85·8–100) | 24/24 (100%; 85·8–100) | 0/23 (0·0%; 0·0–14·8) | 1·00 | ||
Day 28 | 24/24 (100%; 85·8–100) | 24/24 (100%; 85·8–100) | 0/23 (0·0%; 0·0–14·8) | 1·00 | ||
Phase 2 | ||||||
Days 0 and 14 vaccination cohort | ||||||
Neutralising antibodies to live SARS-CoV-2 | ||||||
Day 14 | 109/118 (92·4%; 86·0–96·5) | 117/119 (98·3%; 94·1–99·8) | 2/60 (3·3%; 0·4–11·5) | 0·030 | ||
Day 28 | 111/118 (94·1%; 88·2–97·6) | 117/118 (99·2%; 95·4–100) | 0/60 (0·0%; 0·0–6·0) | 0·066 | ||
RBD-IgG | ||||||
Day 14 | 111/115 (96·5%; 91·3–99·0) | 118/118 (100%; 96·9–100) | 0/56 (0·0%; 0·0–6·4) | 0·058 | ||
Day 28 | 111/114 (97·4%; 92·5–99·5) | 118/118 (100%; 96·9–100) | 0/57 (0·0%; 0·0–6·3) | 0·12 | ||
Days 0 and 28 vaccination cohort | ||||||
Neutralising antibodies to live SARS-CoV-2 | ||||||
Day 28 | 114/117 (97·4%; 92·7–99·5) | 118/118 (100%; 96·9–100) | 0/59 (0·0%; 0·0–6·1) | 0·12 | ||
RBD-IgG | ||||||
Day 28 | 116/117 (99·2%; 95·3–100) | 117/117 (100%; 96·9–100) | 4/59 (6·8%; 1·9–16·5) | 1·00 |
Data are n/N (%; 95% CI). Timepoints refer to the number of days since the second dose of vaccine in the schedule. RBD=receptor binding domain. SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.
p values are for comparisons between the 3 μg and 6 μg groups.