Table.
Baseline demographics
| Overall (n=161) |
HIV-negative participants |
People with HIV |
||||||
|---|---|---|---|---|---|---|---|---|
| Overall (n=58) | Placebo (n=29) | Vaccine (n=29) | Overall (n=103) | Placebo (n=51) | Vaccine (n=52) | |||
| Median (IQR) age, years | 37 (31–44) | 32 (25–42) | 31 (26–42) | 34 (23–41) | 40 (33–46) | 41 (36–46) | 37 (32–45) | |
| Sex | ||||||||
| Female | 98 (61%) | 22 (38%) | 10 (34%) | 12 (41%) | 76 (74%) | 40 (78%) | 36 (69%) | |
| Male | 63 (39%) | 36 (62%) | 19 (66%) | 17 (59%) | 27 (26%) | 11 (22%) | 16 (31%) | |
| Race | ||||||||
| Black | 160 (99%) | 58 (100%) | 29 (100%) | 29 (100%) | 102 (99%) | 51 (100%) | 51 (98%) | |
| White | 1 (1%) | 0 | 0 | 0 | 1 (1%) | 0 | 1 (2%) | |
| Body-mass index, kg/m2 | ||||||||
| <18 | 12 (8%) | 7 (12%) | 4 (14%) | 3 (10%) | 5 (5%) | 1 (2%) | 4 (8%) | |
| 18–24·9 | 68 (42%) | 26 (45%) | 15 (52%) | 11 (38%) | 42 (41%) | 18 (35%) | 24 (46%) | |
| 25–29·9 | 46 (29%) | 13 (22%) | 4 (14%) | 9 (31%) | 33 (32%) | 16 (31%) | 17 (33%) | |
| 30–39·9 | 35 (22%) | 12 (21%) | 6 (21%) | 6 (21%) | 23 (22%) | 16 (31%) | 7 (14%) | |
| Current smoker | 61 (38%) | 27 (47%) | 12 (41%) | 15 (52%) | 34 (33%) | 16 (31%) | 18 (35%) | |
| Current alcohol drinker | 72 (45%) | 25 (43%) | 13 (45%) | 12 (41%) | 47 (46%) | 21 (41%) | 26 (50%) | |
| Health-care worker | 3 (2%) | 1 (2%) | 1 (3%) | 0 | 2 (2%) | 1 (2%) | 1 (2%) | |
| Hypertension | 12 (8%) | 1 (2%) | 0 | 1 (3%) | 11 (11%) | 7 (14%) | 4 (8%) | |
| Chronic respiratory disease | 16 (10%) | 0 | 0 | 0 | 16 (16%) | 10 (20%) | 6 (12%) | |
| HbA1c | ||||||||
| Low | 12 (8%) | 2 (3%) | 0 | 2 (7%) | 10 (10%) | 5 (10%) | 5 (10%) | |
| Normal | 145 (90%) | 53 (91%) | 26 (90%) | 27 (93%) | 92 (89%) | 46 (90%) | 46 (89%) | |
| High | 4 (3%) | 3 (5%) | 3 (10%) | 0 | 1 (1%) | 0 | 1 (2%) | |
| ART use* | ||||||||
| NNRTI and two NRTIs | NA | NA | NA | NA | 57 (76%) | 29 (74%) | 28 (78%) | |
| INSTI and two NRTIs | NA | NA | NA | NA | 11 (15%) | 5 (13%) | 6 (17%) | |
| Boosted PI and one NRTI | NA | NA | NA | NA | 4 (5%) | 3 (8%) | 1 (3%) | |
| Boosted PI and two NRTIs | NA | NA | NA | NA | 3 (4%) | 2 (5%) | 1 (3%) | |
| Years on ART | ||||||||
| <1 | NA | NA | NA | NA | 9 (12%) | 4 (10%) | 5 (14%) | |
| 1 to <5 | NA | NA | NA | NA | 28 (37%) | 12 (31%) | 16 (44%) | |
| ≥5 | NA | NA | NA | NA | 38 (51%) | 23 (59%) | 15 (42%) | |
| Median (IQR) CD4 count, cells per μL | NA | NA | NA | NA | 695 (512–929) | 677 (500–889) | 742 (540–953) | |
| Median (IQR) CD4 percentage | NA | NA | NA | NA | 36 (30–41) | 36 (29–41) | 37 (32–41) | |
| Viral load <50 copies per mL | 27 (75%) | NA | NA | NA | 27 (75%) | 18 (82%) | 9 (64%) | |
| Median (IQR) time between doses, days | 28 (27–28) | 28 (28–28) | 28 (28–28) | 28 (28–28) | 28 (25–28) | 28 (26–28) | 28 (23–28) | |
| Median (IQR) time post-boost, days | 14 (14–14) | 14 (14–15) | 14 (14–14) | 14 (14–15) | 14 (14–14) | 14 (14–14) | 14 (14–14) | |
Data are n (%) unless otherwise stated. Data exclude patients who were SARS-CoV-2 seropositive at baseline and include patients with no baseline serology available. ART=antiretroviral therapy. HbA1c=glycated haemoglobin. INSTI=integrase strand transfer inhibitor. NA=not applicable. NNRTI=non-nucleoside reverse transcriptase inhibitor. NRTI=nucleoside or nucleotide reverse transcriptase inhibitors. PI=protease inhibitors.
Most participants (75%) were receiving an efavirenz-based regimen, 15% were receiving a dolutegravir-based regimen with two NRTIs (tenofovir and lamivudine or emtricitabine), and one participant received zidovidine and lamivudine. The remaining participants received a boosted protease inhibitor-based regimen, either lopinavir plus ritonavir or atazanavir plus ritonavir, with either one or two NRTIs, including lamivudine, zidovudine, abacavir, or tenofovir.