Table 1.
Group | Regimen | Subjects, No. |
Month 0 |
Month 4 |
|||||
---|---|---|---|---|---|---|---|---|---|
Vaccine Group | Placebo Group | Vaccine | Route | Dosea | Vaccine | Route | Dosea | ||
A | SLA | 12 | 4 | SeV-Gag | Intranasal | 2 × 107 | Ad35-GRIN | Intramuscular | 1 × 1010 |
B | SHA | 12 | 4 | SeV-Gag | Intranasal | 2 × 108 | Ad35-GRIN | Intramuscular | 1 × 1010 |
C | ASH | 12 | 5b | Ad35-GRIN | Intramuscular | 1 × 1010 | SeV-Gag | Intranasal | 2 × 108 |
D | SHSH | 12 | 4 | SeV-Gag | Intranasal | 2 × 108 | SeV-Gag | Intranasal | 2 × 108 |
Abbreviations: Ad35-GRIN, adenovirus 35–vectored vaccine encoding Gag, reverse transcriptase, integrase, and Nef; ASH, Ad35-GRIN prime followed by SeV-Gag boost; HIV-1, human immunodeficiency virus type 1; SHA, higher-dose SeV-Gag prime and Ad35-GRIN boost; SHSH, higher-dose SeV-Gag prime and boost; SLA, lower-dose SeV-Gag prime and Ad35-GRIN boost; SeV-Gag, Sendai virus–vectored vaccine encoding HIV-1 Gag.
a Data are 1 × 107 or 1 × 108 cell infectious units/100 µL per nostril (for SeV-Gag) or 1 × 1010 viral particles (for Ad35-GRIN).
b Overenrollment was allowed per protocol; one additional volunteer, identified post unblinding as a placebo recipient, was enrolled.