Table 1.
Participant characteristics stratified by age and sex among the 801 participants enrolled in HVTN 503/Phambili, 2007.
Females 18-20 (n=99) % | Females 21-35 (n=261) % | p-value | Males 18-20 (n=139) % | Males 21-35 (n=302) % | p-value | Overall p-value 18-20 vs. 21-35 | |
---|---|---|---|---|---|---|---|
Race | 0.42 | 0.22 | 0.28 | ||||
Black | 99.0 | 98.8 | 100.0 | 98.7 | |||
Other | 1.0 | 1.2 | 0 | 1.3 | |||
Study site | 0.31 | <0.001 | <0.001 | ||||
Soweto | 40.6 | 40.2 | 47.5 | 31.5 | |||
Cape Town | 25.7 | 29.0 | 4.3 | 20.5 | |||
KOSH | 26.7 | 19.3 | 37.4 | 29.8 | |||
CAPRISA | 5.9 | 7.0 | 4.3 | 7.6 | |||
Medunsa | 1.0 | 4.6 | 6.5 | 10.6 | |||
Adenovirus 5 titer | 0.15 | 0.64 | 0.56 | ||||
<200 | 37.6 | 46.0 | 46.8 | 44.4 | |||
>200 | 63.4 | 54.0 | 53.2 | 55.6 | |||
Risk behaviors in previous 6 months: | |||||||
Number of sexual partners (MEAN) | 1.3 | 1.1 | 0.001 | 2.5 | 2.2 | 0.21 | 0.05 |
Unprotected vaginal sex (YES VS. NO) | 50.5 | 57.1 | 0.25 | 45.7 | 63.5 | <0.001 | <0.001 |
Drinking or drugs with sex (YES VS. NO) | 13.9 | 10.0 | 0.30 | 35.3 | 41.4 | 0.22 | 0.58 |
Casual or anonymous partner (YES VS. NO) | 13.9 | 10.0 | 0.30 | 48.2 | 47.0 | 0.82 | 0.48 |
Exchanged sex for money or gifts (YES VS. NO) | 1.0 | 1.2 | 0.42 | 7.2 | 4.6 | 0.27 | 0.33 |
Sexually transmitted infection (self report) (YES VS. NO) | 3.0 | 6.2 | 0.11 | 2.9 | 7.6 | 0.03 | 0.02 |
Heavy drinking (>5 drinks/day) (MEAN NUMBER OF DAYS) | 1.4 | 1.4 | 0.99 | 6.5 | 7.0 | 0.71 | 0.71 |
Believe vaccine is: | 0.86 | 0.87 | 0.97 | ||||
Very effective | 5.9 | 5.0 | 7.2 | 7.0 | |||
Somewhat effective | 19.8 | 17.8 | 19.4 | 22.9 | |||
Not effective | 2.0 | 1.5 | 2.2 | 2.0 | |||
I don't know | 72.3 | 75.7 | 71.2 | 68.2 | |||
Prior to unblinding, I think I received: | 0.97 | 0.07 | 0.28 | ||||
Vaccine | 31.5 | 32.9 | 51.6 | 42.2 | |||
Placebo | 19.1 | 19.0 | 20.5 | 17.5 | |||
I don't know | 49.4 | 48.2 | 27.9 | 40.2 | |||
Participation in trial had beneficial impact on life | 69.0 | 67.7 | 0.92 | 83.8 | 72.7 | 0.04 | 0.14 |
Social harm from study involvement: | 0.50 | 0.22 | 0.20 | ||||
Minimal disturbance | 5.0 | 8.4 | 0.7 | 3.1 | |||
Moderate/Major disturbance | 2.0 | 1.2 | 0.7 | 2.0 | |||
Loss to follow-up during study | 21.2 | 19.8 | 0.76 | 22.6 | 28.3 | 0.21 | 0.43 |
Adverse event: | |||||||
Related to study product | 1.0 | 8.5 | 0.004 | 7.9 | 7.3 | 0.82 | 0.14 |