Table 2.
Immunogenicity among participants with negative baseline IgG and NAb after one dose (day 28) and two doses (day 69) for people with HIV, according to CD4 cell count categories, and controls
| HIV-positive (n=215) | HIV-negative (n=296) | p value | CD4 count <500 cells per μL (n=64)* | CD4 count ≥500 cells per μL (n=151)* | p value | |
|---|---|---|---|---|---|---|
| Day 69 | ||||||
| IgG titre (AU/mL) | 48·7 (26·6–88·2) | 75·2 (50·3–112.0) | <0·0001 | 42·6 (22·9–68·9) | 53·3 (30·2–92·4) | 0·053 |
| Seroconversion | 185/204 (91%) | 265/274 (97%) | 0·0055 | 51/62 (82%) | 134/142 (94%) | 0·0062 |
| FI-GMT | 22·6 (10·9–41·2) | 31·9 (16·7–53·2) | 0·0003 | 19·4 (7·6–33·5) | 23·1 (11·0–45·0) | 0·12 |
| NAb positivity | 143/202 (71%) | 229/274 (84%) | 0·0008 | 36/61 (59%) | 107/141 (76%) | 0·015 |
| NAb activity (%) | 46·2 (26·9–69·7) | 60·8 (39·8–79·9) | <0·0001 | 41·6 (20·8–64·6) | 49·9 (30·6–73·1) | 0·031 |
| Day 28 | ||||||
| IgG titre (AU/mL) | 5·2 (0·0–11·3) | 10·4 (4·7–30·5) | <0·0001 | 5·2 (0·0–7·9) | 5·1 (0·0–12·3) | 0·45 |
| Seroconversion | 41/214 (19%) | 114/295 (39%) | <0·0001 | 10/64 (16%) | 31/150 (21%) | 0·39 |
| FI-GMT | 2·4 (1·0–5·3) | 4·7 (2·3–10·4) | <0·0001 | 2·3 (1·0–3·9) | 2·5 (1·0–6·0) | 0·34 |
| NAb positivity | 40/211 (19%) | 112/289 (39%) | <0·0001 | 7/64 (11%) | 33/147 (22%) | 0·050 |
| NAb activity (%) | 0·0 (0·0–27·3) | 23·7 (0–39·6) | <0·0001 | 0·0 (0·0–0·0) | 0·0 (0·0–29·4) | 0·0025 |
Data are median (IQR) or n/N (%). Seroconversion is when positive IgG is 15AU/mL or more. NAb test is positive when 30% or greater. FI-GMT=factor of increase-geometric mean titre. NAb=neutralising antibody test.
*
People with HIV.