Table 1:
Clinical Characteristics of study participants Unless specified, all data are presented as n (%N);
| Arm A Full-dose Ad26.COV2.S | Arm B Half-dose Ad26.COV2.S | Arm C Full-dose BNT162b2 | Arm D Half-dose BNT162b2 | Total | |
|---|---|---|---|---|---|
|
| |||||
| Vaccinated (N) | 74 | 69 | 73 | 73 | 289 |
|
| |||||
| Age * | 42 (35–48) | 40 (35–45) | 43 (35–50) | 42 (35–49) | 42 (35–49) |
| 18–29 years | 5 (6.8%) | 5 (7.2%) | 7 (9.6%) | 6 (8.2%) | 23 (8%) |
| 30–44 years | 41 (55.4%) | 46 (66.7%) | 34 (46.6%) | 34 (46.6%) | 155 (53.6%) |
| 45–54 years | 20 (27%) | 10 (14.5%) | 23 (31.5%) | 22 (30.1%) | 75 (26%) |
| ≥ 55 years | 8 (10.8%) | 8 (11.6%) | 9 (12.3%) | 11 (15.1%) | 36 (12.5%) |
|
| |||||
| Sex | |||||
| Male | 10 (13.5%) | 8 (11.6%) | 18 (24.7%) | 15 (20.5%) | 51 (17.6%) |
| Female | 64 (86.5%) | 61 (88.4%) | 55 (75.3%) | 58 (79.5%) | 238 (82.4%) |
|
| |||||
| Ethnicity | |||||
| Black African | 69 (93.2%) | 67 (97.1%) | 69 (94.5%) | 70 (95.9%) | 275 (95.2%) |
| Other | 5 (6.8%) | 2 (2.9%) | 4 (5.5%) | 3 (4.1%) | 14 (4.8%) |
|
| |||||
| Days between prime and Booster* | 265 (245–292) | 271 (259–302) | 273 (258–291) | 272 (253–300) | 271 (255–296) |
|
| |||||
| BMI | |||||
| Underweight | 0 (0%) | 2 (2.9%) | 0 (0%) | 1 (1.4%) | 3 (1%) |
| Normal | 12 (16.2%) | 8 (11.6%) | 14 (19.2%) | 6 (8.2%) | 40 (13.8%) |
| Overweight | 20 (27%) | 41 (59.4%) | 39 (53.4%) | 47 (64.4%) | 71 (24.6%) |
| Obese | 41 (55.4%) | 39 (56.5%) | 47 (64.4%) | 47 (64.4%) | 174 (60.2%) |
| Not available | 1 (1.4%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| HIV infection | |||||
| HIV Positive | 27 (36.5%) | 28 (40.6%) | 31 (42.5%) | 30 (41.1%) | 116 (40.1%) |
| Viremic$ | 1 (3.7%) | 5 (17.9%) | 4 (12.9%) | 6 (20%) | 16 (13.8%) |
| CD4 count (cells/mm3)* | 223 (na) | 452 (103–471) | 1136 | 341 (132–538) | 452 (132–538) |
| Viral load (copies/mL)* | 818 | 5838 | 29911 | 19960 | 15376 |
| na | (3054–18252) | (14863–47207) | (5324–37713) | (3054–27420) | |
| Aviremic$ | 26 (96.3%) | 23 (82.1%) | 27 (87.1%) | 24 (80%) | 100 (86.2%) |
| CD4 count (cells/mm3)* | 698 (580–923) | 677 (530–855) | 812 (623–931 | 666 (538–737) | 708 (558–922) |
|
| |||||
| Prior SARS-CoV-2 infection & | 51/58 (87.8%) | 52/57 (91.2%) | 55/59 (93.2%) | 55/59 (93.2%) | 213/223 (91.4%) |
|
| |||||
| Co-morbidities | |||||
| Hypertension | 19 (25.7%) | 8 (11.6%) | 17 (23.3%) | 17 (23.3%) | 61 (21.1%) |
| Anaemia | 7 (9.5%) | 8 (11.6%) | 6 (8.2%) | 9 (12.3%) | 30 (10.4%) |
| Asthma | 6 (8.1%) | 3 (4.3%) | 2 (2.7%) | 1 (1.4%) | 12 (4.2%) |
| Diabetes mellitus | 3 (4.1%) | 1 (1.4%) | 4 (5.5%) | 4 (5.5%) | 12 (4.2%) |
| Arthritis | 1 (1.4%) | 0 (0%) | 3 (4.1%) | 3 (4.1%) | 7 (2.4%) |
| Tuberculosis | 0 (0%) | 4 (5.8%) | 2 (2.7%) | 0 (0%) | 6 (2.1%) |
|
| |||||
| Retention | |||||
| W2 visits completed | 74 (100%) | 66 (95.7%) | 72 (98.6%) | 69 (94.5%) | 281 (97.2%) |
| W12 visits completed | 74 (100%) | 67 (97.1%) | 67 (91.8%) | 70 (95.9%) | 278 (96.2%) |
| W24 visits completed | 69 (93.2%) | 63 (91.3%) | 69 (94.5%) | 68 (93.2%) | 269 (93.1%) |
*
median and interquartile range (IQR);
$
% is of all HIV-infected participants; Viremic individuals were defined as having a HIV-1 viral load (VL) >200 HIV mRNA copies/mm3; 3 participants in the viremic arm C had a missing CD4 count;
&
Prior SARS-CoV-2 infection was defined by the presence of Nucleocapsid-specific IgG; na: non-applicable.