Table 4.
Comparison of neutralising antibody titres specific for wild-type SARS-CoV-2 at 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 | ||||||
| N1 | 1255 | 63 | 680 | 39 | 1941 | 102 |
| NVX-CoV2373 group (95% CI*) | 10·2 (10·1–10·3) | 10·4 (10·0–10·9) | 56·9 (51·7–62·7) | 74·5 (48·3–115·0) | 18·6 (17·7–19·6) | 22·1 (17·3–28·4) |
| N1 | 1187 | 65 | 734 | 38 | 1928 | 103 |
| Placebo group (95% CI*) | 10·3 (10·1–10·4) | 10·4 (9·9–11·0) | 52·3 (47·6–57·3) | 70·4 (48·3–102·7) | 19·2 (18·2–20·2) | 21·1 (16·8–26·5) |
| GMT at day 35 | ||||||
| N1 | 1224 | 61 | 650 | 39 | 1879 | 100 |
| NVX-CoV2373 group (95% CI*) | 714·7 (664·7–768·5) | 320·0 (228·1–448·9) | 3105·0 (2823·3–3414·9) | 2748·6 (1478·2–5110·9) | 1188·1 (1112·6–1268·7) | 740·3 (508·7–1077·3) |
| N1 | 1161 | 64 | 700 | 37 | 1867 | 101 |
| Placebo group (95% CI*) | 10·8 (10·5–11·1) | 12·0 (10·6–13·6) | 64·4 (58·3–71·2) | 61·5 (39·5–95·9) | 21·2 (20·0–22·4) | 21·9 (17·3–27·7) |
| GMFR at day 35† | ||||||
| NVX-CoV2373 group | 70·4 | 30·6 | 53·4 | 36·9 | 64·0 | 32·9 |
| Placebo group | 1·1 | 1·2 | 1·2 | 0·9 | 1·1 | 1·1 |
| SCR (≥4-fold increase) at day 35, N2/N1 (%) | ||||||
| NVX-CoV2373 group | 1188/1224 (97·1%) | 60/61 (98·4%) | 633/650 (97·4%) | 36/39 (92·3%) | 1826/1879 (97·2%) | 96/100 (96·0%) |
| Placebo group | 23/1161 (2·0%) | 4/64 (6·3%) | 94/700 (13·4%) | 5/37 (13·5%) | 117/1867 (6·3%) | 9/101 (8·9%) |
| SRR at day 35, N2/N1 (%)† | ||||||
| NVX-CoV2373 group | 849/1224 (69·4%) | 22/61 (36·1%) | 596/650 (91·7%) | 32/39 (82·1%) | 1449/1826 (77·1%) | 54/100 (54·0%) |
| Placebo | 5/1161 (0·4%) | 0/64 (0·0%) | 57/700 (8·1%) | 2/37 (5·4%) | 63/1879 (3·4%) | 2/101 (2·0%) |
Values shown are for all participants in each category; data for all participants are included in the appendix (p 19). 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.