Table.
Vaccination schedules and masking of interventions
| Month 0 | Month 1 | Month 3 | Month 6 | ||
|---|---|---|---|---|---|
| Vaccination schedule 1 | |||||
| T1 (n=20) | |||||
| Left deltoid | NYVAC vector (2 injections) | NYVAC vector (2 injections) | NYVAC vector (2 injections) | NYVAC vector (2 injections) | |
| Right deltoid | Placebo* | Placebo* | gp120 Env protein† | gp120 Env protein† | |
| C1 (n=4) | |||||
| Left deltoid | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | |
| Right deltoid | Placebo* | Placebo* | Placebo‡ | Placebo‡ | |
| Vaccination schedule 2 | |||||
| T2 (n=20) | |||||
| Left deltoid | NYVAC vector (2 injections) | NYVAC vector (2 injections) | NYVAC vector (2 injections) | NYVAC vector (2 injections) | |
| Right deltoid | gp120 Env protein† | gp120 Env protein† | gp120 Env protein† | gp120 Env protein† | |
| C2 (n=4) | |||||
| Left deltoid | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | |
| Right deltoid | Placebo‡ | Placebo‡ | Placebo‡ | Placebo‡ | |
| Vaccination schedule 3 | |||||
| T3 (n=20) | |||||
| Left deltoid | DNA vector + placebo* | DNA vector + placebo* | NYVAC vector (2 injections) | NYVAC vector (2 injections) | |
| Right deltoid | Placebo* | Placebo* | gp120 Env protein† | gp120 Env protein† | |
| C3 (n=4) | |||||
| Left deltoid | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | |
| Right deltoid | Placebo* | Placebo* | Placebo‡ | Placebo‡ | |
| Vaccination schedule 4 | |||||
| T4 (n=20) | |||||
| Left deltoid | DNA vector + placebo* | DNA vector + placebo* | NYVAC vector (2 injections) | NYVAC vector (2 injections) | |
| Right deltoid | gp120 Env protein† | gp120 Env protein† | gp120 Env protein† | gp120 Env protein† | |
| C4 (n=4) | |||||
| Left deltoid | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | Placebo* (2 injections) | |
| Right deltoid | Placebo‡ | Placebo‡ | Placebo‡ | Placebo‡ | |
Placebo injections were used to equalise the number of injections among groups and achieve masking of assignments. T=treatment group. C=control group. Env=envelope.
*
Sodium chloride (0·9%) was used as the placebo for NYVAC and DNA vectors.
†
AIDSVAX B/E.
‡
600 μg of aluminium hydroxide adjuvant was used as the placebo for AIDSVAX B/E.