Table 3.
Comparison of serum ACE-2 receptor-binding inhibition titres specific for SARS-CoV-2 recombinant spike protein antigen at day 21 and day 35 (per-protocol immunogenicity analysis set)
|
Baseline SARS-CoV-2-seronegative |
Baseline SARS-CoV-2-positive |
Overall |
||||
|---|---|---|---|---|---|---|
| HIV-negative | People living with HIV-1 | HIV-negative | People living with HIV-1 | HIV-negative | People living with HIV-1 | |
| GMT at day 0, EU/mL | ||||||
| N1 | 1261 | 63 | 682 | 39 | 1948 | 102 |
| NVX-CoV2373 group (95% CI*) | 5·0 (5·0–5·0) | 5·0 (5·0–5·0) | 8·1 (7·6–8·6) | 8·6 (6·6–11·1) | 5·9 (5·8–6·1) | 6·1 (5·5–6·9) |
| N1 | 1191 | 66 | 742 | 39 | 1934 | 105 |
| Placebo group (95% CI*) | 5·0 (5·0–5·0) | 5·0 (5·0–5·0) | 8·1 (7·7–8·6) | 7·8 (6·5–9·4) | 6·0 (5·9–6·2) | 5·9 (5·4–6·4) |
| GMT at day 21, EU/mL | ||||||
| N1 | 1235 | 61 | 663 | 37 | 1905 | 98 |
| NVX-CoV2373 group (95% CI*) | 5·6 (5·5–5·8) | 5·3 (4·8–5·8) | 84·4 (74·7–95·4) | 96·6 (56·7–164·7) | 14·4 (13·4–15·5) | 15·8 (11·2–22·4) |
| N1 | 1166 | 60 | 722 | 37 | 1893 | 97 |
| Placebo group (95% CI*) | 5·1 (5·0–5·1) | 5·3 (4·7–5·9) | 7·8 (7·4–8·3) | 7·2 (6·0–8·5) | 6·0 (5·9–6·1) | 5·9 (5·4–6·5) |
| GMFR at day 21† | ||||||
| NVX-CoV2373 group | 1·1 | 1·1 | 10·3 | 10·9 | 2·4 | 2·6 |
| Placebo group | 1·0 | 1·1 | 1·0 | 0·9 | 1·0 | 1·0 |
| SCR (≥4-fold increase) at day 21, N2/N1 (%) | ||||||
| NVX-CoV2373 group | 44/1235 (3·6%) | 1/61 (1·6%) | 492/663 (74·2%) | 27/37 (73·0%) | 537/1905 (28·2%) | 28/98 (28·6%) |
| Placebo group | 7/1166 (0·6%) | 1/60 (1·7%) | 12/722 (1·7%) | 0/37 (0·0%) | 19/1893 (1·0%) | 1/97 (1·0%) |
| SRR at day 21, N2/N1 (%)† | ||||||
| NVX-CoV2373 group | 43/1235 (3·5%) | 1/61 (1·6%) | 520/663 (78·4%) | 29/37 (78·4%) | 564/1905 (29·6%) | 30/98 (30·6%) |
| Placebo group | 7/1166 (0·6%) | 1/60 (1·7%) | 84/722 (11·6%) | 1/37 (2·7%) | 92/1893 (4·9%) | 2/97 (2·1%) |
| GMT at day 35, EU/mL | ||||||
| N1 | 1220 | 61 | 644 | 38 | 1870 | 99 |
| NVX-CoV2373 group (95% CI*) | 87·3 (81·4–93·6) | 39·7 (28·3–55·8) | 322·4 (296·3–350·9) | 331·4 (204·8–536·3) | 137·1 (129·0–145·7) | 89·7 (63·6–126·4) |
| N1 | 1160 | 62 | 697 | 38 | 1862 | 100 |
| Placebo group (95% CI*) | 5·1 (5·0–5·2) | 5·1 (4·9–5·4) | 8·4 (7·9–9·0) | 8·7 (6·3–12·0) | 6·2 (6·0–6·4) | 6·3 (5·5–7·1) |
| GMFR at day 35† | ||||||
| NVX-CoV2373 group | 17·4 | 7·9 | 39·3 | 40·9 | 23·0 | 14·9 |
| Placebo group | 1·0 | 1·0 | 1·0 | 1·1 | 1·0 | 1·1 |
| SCR (≥ 4-fold increase) at day 35, N2/N1 (%) | ||||||
| NVX-CoV2373 group | 1059/1220 (86·8%) | 45/61 (73·8%) | 612/644 (95·0%) | 36/38 (94·7%) | 1675/1870 (89·6%) | 81/99 (81·8%) |
| Placebo group | 7/1160 (0·6%) | 1/62 (1·6%) | 29/697 (4·2%) | 3/38 (7·9%) | 36/1862 (1·9%) | 4/100 (4·0%) |
| SRR at day 35, N2/N1 (%)† | ||||||
| NVX-CoV2373 group | 1010/1220 (83·6%) | 43/61 (70·5%) | 616/644 (95·7%) | 35/38 (92·1%) | 1642/1870 (87·8%) | 78/99 (78·8%) |
| Placebo group | 7/1160 (0·6%) | 0/62 (0·0%) | 85/697 (12·2%) | 4/38 (10·5%) | 93/1862 (5·0%) | 4/100 (4·0%) |
Values shown are for all participants in each category; data for all participants are included in the appendix (pp 16–17). ACE=angiotensin-converting enzyme. EU=ELISA units. GMFR=geometric mean fold rise. GMT=geometric mean titre. N1=the number of participants in the per-protocol immunogenicity analysis set within each visit with non-missing data. N2=the number of participants who reported the event. NVX-CoV2373=5 μg SARS-CoV-2 recombinant spike protein nanoparticle vaccine with 50 μg Matrix-M adjuvant. SCR=seroconversion rate. SRR=seroresponse rate.
The 95% CIs for GMTs were calculated on the basis of the t distribution of the log-transformed values, and then back-transformed to the original scale for presentation.
Referencing day 0.