Table 2.
Comparison of serum IgG antibody 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 | 1260 | 62 | 682 | 39 | 1942 | 101 |
| NVX-CoV2373 group (95% CI*) | 111·4 (109·4–113·5) | 116·0 (104·1–129·3) | 1713·0 (1536·2–1910·0) | 1852·9 (1195·4–2871·9) | 290·9 (271·1–312·2) | 338·2 (245·3–466·2) |
| N1 | 1190 | 65 | 746 | 38 | 1936 | 103 |
| Placebo (95% CI*) | 113·9 (111·6–116·3) | 110·9 (101·9–120·6) | 1525·2 (1361·6–1708·4) | 1760·7 (1246·1–2487·8) | 309·6 (288·0–332·8) | 307·5 (229·0–412·8) |
| GMT at day 21, EU/mL | ||||||
| N1 | 1234 | 62 | 662 | 39 | 1899 | 101 |
| NVX-CoV2373 group (95% CI*) | 1195·3 (1116·6–1279·5) | 508·6 (382·2–676·9) | 21 137·5 (18 571·1–24 058·6) | 19 240·0 (9824·8–37 678·0) | 3253·5 (2978·7–3553·6) | 2068·5 (1298·3–3295·5) |
| N1 | 1161 | 64 | 724 | 36 | 1889 | 100 |
| Placebo group (95% CI*) | 118·8 (114·9–122·8) | 126·5 (103·5–154·8) | 1398·3 (1252·2–1561·4) | 1698·3 (1182·0–2440·0) | 306·0 (284·9–328·8) | 322·3 (237·2–437·9) |
| GMFR at day 21† | ||||||
| NVX-CoV2373 group | 10·7 | 4·4 | 12·2 | 10·4 | 11·2 | 6·1 |
| Placebo group | 1·0 | 1·1 | 0·9 | 1·0 | 1·0 | 1·1 |
| SCR (≥4-fold increase) at day 21, N2/N1 (%) | ||||||
| NVX-CoV2373 group | 1003/1234 (81·3%) | 32/62 (51·6%) | 544/662 (82·2%) | 29/39 (74·4%) | 1547/1899 (81·5%) | 61/101 (60·4%) |
| Placebo group | 24/1161 (2·1%) | 2/64 (3·1%) | 28/724 (3·9%) | 1/36 (2·8%) | 52/1889 (2·8%) | 3/100 (3·0%) |
| SRR at day 21, N2/N1 (%)† | ||||||
| NVX-CoV2373 group | 81/1234 (6·6%) | 1/62 (1·6%) | 526/662 (79·5%) | 30/39 (76·9%) | 607/1899 (32·0%) | 31/101 (30·7%) |
| Placebo group | 7/1161 (0·6%) | 1/64 (1·6%) | 86/724 (11·9%) | 2/36 (5·6%) | 93/1889 (4·9%) | 3/100 (3·0%) |
| GMT at day 35, EU/mL | ||||||
| N1 | 1216 | 58 | 638 | 39 | 1857 | 97 |
| NVX-CoV2373 group (95% CI*) | 31 631·8 (29 712·6–33 675·1) | 14 420·5 (10 603·0–19 612·3) | 100 666·1 (92 996·2–108 968·5) | 98 399·5 (61 857·0–15 6529·7) | 47 103·8 (44 575·2–49 775·7) | 31 210·8 (22 665·4–42 977·9) |
| N1 | 1153 | 64 | 693 | 38 | 1850 | 102 |
| Placebo group (95% CI*) | 125·0 (120·2–130·0) | 146·5 (117·5–182·7) | 1730·9 (1561·4–1918·8) | 1880·2 (1220·2–2897·1) | 334·9 (311·0–360·5) | 379·1 (275·2–522·2) |
| GMFR at day 35† | ||||||
| NVX-CoV2373 group | 283·7 | 123·0 | 56·1 | 53·1 | 162·4 | 87·8 |
| Placebo group | 1·1 | 1·3 | 1·1 | 1·1 | 1·1 | 1·2 |
| SCR (≥4-fold increase) at day 35, N2/N1 (%) | ||||||
| NVX-CoV2373 group | 1208/1216 (99·3%) | 58/58 (100·0%) | 621/638 (97·3%) | 36/39 (92·3%) | 1829/1857 (98·5%) | 94/97 (96·9%) |
| Placebo group | 39/1153 (3·4%) | 5/64 (7·8%) | 70/693 (10·1%) | 3/38 (7·9%) | 109/1850 (5·9%) | 8/102 (7·8%) |
| SRR at day 35, N2/N1 (%)† | ||||||
| NVX-CoV2373 group | 1107/1216 (91·0%) | 42/58 (72·4%) | 623/682 (97·6%) | 35/39 (89·7%) | 1733/1857 (93·3%) | 77/97 (79·4%) |
| Placebo group | 7/1153 (0·6%) | 0/64 (0·0%) | 86/746 (12·4%) | 4/38 (10·5%) | 93/1850 (5·0%) | 4/102 (3·9%) |
Values shown are for all participants in each category; data for all participants are included in the appendix (pp 13–14). EU=ELISA units. GMFR=geometric mean fold rise. GMT=geometric mean titre. N1=number of participants in the per-protocol immunogenicity analysis set within each visit with non-missing data. N2=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.