Table 3. Frequency of interferon-γ T cell ELISpot, intracellular cytokine staining, binding and neutralizing antibody and Ad5 vector responses.
| Placebo | Vaccine | ||||||
| N | % | 95% CI | N | % | 95% CI | ||
| IFN-γ ELISpot * | Overall | 194 | 3.1 | 1.4–6.6 | 192 | 70.8 | 64.0–76.8 |
| Region | |||||||
| LAC | 23 | 4.3 | 0.8–21.0 | 24 | 70.8 | 50.8–85.1 | |
| USA | 74 | 1.4 | 0.2–7.3 | 75 | 73.3 | 62.4–82.0 | |
| South Africa | 97 | 4.1 | 1.6–10.1 | 93 | 68.8 | 58.8–77.3 | |
| Antigen | |||||||
| Env | 194 | 2.1 | 0.8–5.2 | 192 | 54.2 | 47.1–61.1 | |
| Gag | 194 | 0.5 | 0.1–2.9 | 192 | 54.7 | 47.6–61.6 | |
| Nef | 194 | 0.0 | 0.0–1.9 | 192 | 17.2 | 12.5–23.2 | |
| Pol | 194 | 0.5 | 0.1–2.9 | 192 | 23.4 | 18.0–29.9 | |
| Intracellular Cytokine Staining * | CD4 | ||||||
| Overall | 144 | 4.9 | 2.4–9.7 | 134 | 41.8 | 33.8–50.3 | |
| Env | 144 | 3.5 | 1.5–7.9 | 134 | 21.6 | 15.5–29.4 | |
| Gag | 144 | 1.4 | 0.4–4.9 | 134 | 34.3 | 26.8–42.7 | |
| Nef | 144 | 0.0 | 0.0–2.6 | 134 | 6.7 | 3.6–12.3 | |
| Pol | 144 | 0.0 | 0.0–2.6 | 134 | 0.0 | 0.0–2.8 | |
| CD8 | |||||||
| Overall | 167 | 2.4 | 0.9–6.0 | 161 | 47.2 | 39.6–54.9 | |
| Env | 167 | 1.8 | 0.6–5.1 | 161 | 32.3 | 25.6–39.9 | |
| Gag | 165 | 0.6 | 0.1–3.4 | 159 | 13.8 | 9.3–20.1 | |
| Nef | 167 | 0.0 | 0.0–2.2 | 161 | 8.7 | 5.3–14.1 | |
| Pol | 167 | 0.0 | 0.0–2.2 | 161 | 15.5 | 10.7–21.9 | |
| Ad5 vector responses * | |||||||
| Any | 115 | 51.3 | 42.3–60.2 | 116 | 75.0 | 66.4–82.0 | |
| CD4 | 92 | 62.0 | 51.7–71.2 | 92 | 83.7 | 74.8–89.9 | |
| CD8 | 115 | 13.9 | 8.7–21.4 | 116 | 37.9 | 29.6–47.0 | |
| Binding antibody responses ** | gp140 Con S | 209 | 1.0 | 0.3–3.4 | 202 | 94.6 | 90.5–96.9 |
| gp140 Clade C | 209 | 0 | 0.0–1.8 | 202 | 93.1 | 88.7–95.8 | |
| gp140 Clade A | 209 | 0 | 0.0–1.8 | 202 | 83.7 | 77.9–88.1 | |
| gp140Clade B | 209 | 0 | 0.0–1.8 | 202 | 94.6 | 90.5–96.9 | |
| gp41 | 209 | 0.5 | 0.1–2.7 | 202 | 93.1 | 88.7–95.8 | |
| P55 | 209 | 1.0 | 0.3–3.4 | 202 | 45.5 | 38.8–52.4 | |
| Neutralizing antibody responses ** | 92RW020.2 | 218 | 0.0 | 0.0–1.7 | 220 | 0.0 | 0.0–1.7 |
| 97ZA012.29 | 218 | 0.0 | 0.0–1.7 | 220 | 0.0 | 0.0–1.7 | |
| Bal.26 | 218 | 0.0 | 0.0–1.7 | 220 | 0.9 | 0.2–3.3 | |
| MN | 218 | 5.0 | 2.8–8.8 | 220 | 18.6 | 14.0–24.3 | |
| SF162.LS | 218 | 0.0 | 0.0–1.7 | 220 | 7.7 | 4.9–12.0 | |
All responses are to Global PTE peptide pools.
*6 weeks after Ad5 boost,
**4 weeks after rAd5 boost. USA = United States of America. LAC = Latin America and Caribbean. N's refer to number of samples with evaluable data (that passed all quality control filters). ELISpot assays were run on 209 placebos (P) and 205 vaccinees (V): Latin America: 24 P, 24 V; USA: 81 P, 80 V; South Africa: 104 P, 101 V. CD4 and CD8 ICS assays were run on 175 P and 167 V; Ad5 vector ICS assays were run on 115 P and 116 V. Neutralizing antibody assays were run on 220 P and 222 V. Luminex binding antibody assays were run on 219 P and 206 V.