Table 1.
Baseline Demographic Characteristics of Participants in the Primary Efficacy Cohort
| Characteristic | Participants, No. (%)a | |||
|---|---|---|---|---|
| Total | Randomized Arms | Vaccine-Declined Group (No Vaccine) | ||
| Immediate | SoC | |||
| Total no. SARS-CoV-2 negative at baselineb | 1460 | 600 | 549 | 311 |
| Sex assigned at birth | ||||
| Male | 641 (43.9) | 259 (43.2) | 255 (46.4) | 127 (40.8) |
| Female | 819 (56.1) | 341 (56.8) | 294 (53.6) | 184 (59.2) |
| Gender identityc | ||||
| Man | 630 (43.2) | 255 (42.5) | 249 (45.4) | 126 (40.5) |
| Woman | 788 (54.0) | 327 (54.5) | 286 (52.1) | 175 (56.3) |
| Transgender man | 6 (0.4) | 4 (0.7) | 1 (0.2) | 1 (0.3) |
| Transgender woman | 3 (0.2) | 1 (0.2) | 2 (0.4) | 0 (0.0) |
| Gender nonconforming or gender variant | 25 (1.7) | 8 (1.3) | 13 (2.4) | 4 (1.3) |
| Genderqueer | 11 (0.8) | 7 (1.2) | 3 (0.5) | 1 (0.3) |
| Additional identity | 8 (0.5) | 4 (0.7) | 2 (0.4) | 2 (0.6) |
| Prefer not to answer | 9 (0.6) | 5 (0.8) | 0 (0.0) | 4 (1.3) |
| Raced | ||||
| American Indian or Alaska Native | 6 (0.4) | 2 (0.3) | 3 (0.5) | 1 (0.3) |
| Asian | 201 (13.8) | 97 (16.2) | 93 (16.9) | 11 (3.5) |
| Black or African American | 143 (9.8) | 47 (7.8) | 49 (8.9) | 47 (15.1) |
| Multiple | 121 (8.3) | 52 (8.7) | 43 (7.8) | 26 (8.4) |
| Native Hawaiian or other Pacific Islander | 4 (0.3) | 2 (0.3) | 1 (0.2) | 1 (0.3) |
| Other | 40 (2.7) | 19 (3.2) | 13 (2.4) | 8 (2.6) |
| Prefer not to answer | 50 (3.4) | 23 (3.8) | 13 (2.4) | 14 (4.5) |
| White | 895 (61.3) | 358 (59.7) | 334 (60.8) | 203 (65.3) |
| Ethnicity | ||||
| Hispanic or Latino/a | 276 (18.9) | 106 (17.7) | 99 (18.0) | 71 (22.8) |
| Not Hispanic or Latino/a | 1175 (80.5) | 490 (81.7) | 448 (81.6) | 237 (76.2) |
| Age | ||||
| 18–22 y | 1008 (69.0) | 449 (74.8) | 402 (73.2) | 157 (50.5) |
| 23–26 y | 334 (22.9) | 122 (20.3) | 128 (23.3) | 84 (27.0) |
| 27–29 y | 118 (8.1) | 29 (4.8) | 19 (3.5) | 70 (22.5) |
| Median (range), y | 21 (18, 29) | 21 (18, 29) | 21 (18, 29) | 22 (18, 29) |
| Residence | ||||
| Dormitory or campus housing | 186 (12.7) | 87 (14.5) | 78 (14.2) | 21 (6.8) |
| Fraternity or sorority house | 19 (1.3) | 9 (1.5) | 10 (1.8) | 0 (0.0) |
| Apartment building or condominium | 689 (47.2) | 285 (47.5) | 258 (47.0) | 146 (46.9) |
| Stand-alone house (not a fraternity or sorority) | 496 (34.0) | 190 (31.7) | 178 (32.4) | 128 (41.2) |
| Shelter | 3 (0.2) | 0 (0.0) | 1 (0.2) | 2 (0.6) |
| RV/trailer | 10 (0.7) | 4 (0.7) | 3 (0.5) | 3 (1.0) |
| Staying with friends/”couch surfing” | 9 (0.6) | 4 (0.7) | 3 (0.5) | 2 (0.6) |
| No residence | 2 (0.1) | 0 (0.0) | 0 (0.0) | 2 (0.6) |
| Other | 45 (3.1) | 21 (3.5) | 18 (3.3) | 6 (1.9) |
| No. of people in shared communal space | ||||
| 0 | 166 (11.4) | 66 (11.0) | 63 (11.5) | 37 (11.9) |
| 1 | 412 (28.2) | 172 (28.7) | 145 (26.4) | 95 (30.5) |
| 2 | 304 (20.8) | 118 (19.7) | 124 (22.6) | 62 (19.9) |
| >2 | 573 (39.2) | 243 (40.5) | 216 (39.3) | 114 (36.7) |
| Student | ||||
| Yes | 1262 (86) | 560 (93) | 504 (92) | 198 (64) |
| No | 193 (13.2) | 39 (6.5) | 44 (8.0) | 110 (35) |
Abbreviations: RV, recreational vehicle; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SoC, standard of care.
aData represent no. (%) of participants unless otherwise specified. Owing to missing data, numbers may not add up to the totals for each group and percentages may not sum to 100%.
bPolymerase chain reaction negative on the first swab sample and seronegative at the first blood sample collection.
cParticipants may report >1 gender identity, so numbers may total to >100%.
dParticipants may report >1 racial category; those who do so are categorized as “multiple.” The denominator for all percentages is the total baseline number SARS-CoV-2 negative.