Table 1.

Participant Characteristics by Region

	Asia (N=12)	Caribbean (N=116)	South America (N=255)	Sub-Saharan Africa (N=1435)	United States/ Switzerland (N=6529)	Total (N=8347)
Sex at birth
Male	9 (75.0%)	63 (54.3%)	135 (52.9%)	751 (52.3%)	4727 (72.4%)	5685 (68.1%)
Female	3 (25.0%)	53 (45.7%)	120 (47.1%)	684 (47.7%)	1802 (27.6%)	2662 (31.9%)
Age at enrollment (years)
18–24	1 (8.3%)	36 (31.0%)	118 (46.3%)	894 (62.3%)	2106 (32.3%)	3155 (37.8%)
25–34	5 (41.7%)	47 (40.5%)	77 (30.2%)	496 (34.6%)	2311 (35.4%)	2936 (35.2%)
35–44	6 (50.0%)	26 (22.4%)	43 (16.9%)	40 (2.8%)	1403 (21.5%)	1518 (18.2%)
45–60 (6 were 51–58)	0 (0.0%)	7 (6.0%)	17 (6.7%)	5 (0.3%)	709 (10.9%)	738 (8.8%)
Median (25th, 75th percentile)	33 (27,40)	28 (23,36)	25 (21,34)	23 (20, 27)	28 (23, 38)	27 (22, 36)
Min, Max	24, 42	18, 58	18, 55	18, 55	18, 60	18, 60
Race/ethnicity
Asian/Hawaiian/ Pacific Islander	12 (100.0%)	1 (0.9%)	0 (0.0%)	0 (0.0%)	159 (2.4%)	172 (2.1%)
Black, non-Hispanic/Latino	0 (0.0%)	98 (84.5%)	1 (0.4%)	1421 (99.0%)	1039 (15.9%)	2559 (30.7%)
Hispanic/Latino	0 (0.0%)	0 (0.0%)	242 (94.9%)	0 (0.0%)	523 (8.0%)	765 (9.2%)
White, non-Hispanic/Latino	0 (0.0%)	0 (0.0%)	10 (3.9%)	5 (0.3%)	4542 (69.6%)	4557 (54.6%)
Multiracial	0 (0.0%)	17 (14.7%)	2 (0.8%)	0 (0.0%)	195 (3.0%)	214 (2.6%)
Other	0 (0.0%)	0 (0.0%)	0 (0.0%)	9 (0.6%)	66 (1.0%)	75 (0.9%)
Unknown	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	5 (0.1%)	5 (0.1%)
Trial phase
Phase 1	12 (100.0%)	80 (69.0%)	183 (71.8%)	394 (27.5%)	3264 (50.0%)	3933 (47.1%)
Phase 2a	0 (0.0%)	36 (31.0%)	72 (28.2%)	240 (16.7%)	761 (11.7%)	1109 (13.3%)
Phase 2b Efficacy	0 (0.0%)	0 (0.0%)	0 (0.0%)	801 (55.8%)	2504 (38.4%)	3305 (39.6%)
Treatment group
Vaccine	10 (83.3%)	78 (67.2%)	199 (78.0%)	845 (58.9%)	4596 (70.4%)	5728 (68.6%)
Control	2 (16.7%)	38 (32.8%)	56 (22.0%)	590 (41.1%)	1933 (29.6%)	2619 (31.4%)