Table 2.
Summary of Ad26 HIV vaccine clinical studies.
| Study | Sponsor (IND holder) | Vaccine | Status | Phase/Blind/Allocation/Participants/Country | Protocol-specified vaccination groups | Planned number of participants | Reference NCT No. |
|---|---|---|---|---|---|---|---|
| IPCAVD-001 | DAIDS | Ad26.ENVA.01 | Completed | Phase 1/Double-blind (observer-blind)/Randomized/Healthy adults/US | 1 × 109 vp Ad26.ENVA.01 (Weeks 0, 4, 24) | 10 |
NCT00618605 [28], [29] |
| 1 × 1010 vp Ad26.ENVA.01 (Weeks 0, 4, 24) | 10 | ||||||
| 1 × 1011 vp Ad26.ENVA.01 (Weeks 0, 4, 24) | 10 | ||||||
| 5 × 1010 vp Ad26.ENVA.01 (Weeks 0, 24) | 10 | ||||||
| 1 × 1010 vp Ad26.ENVA.01 (Weeks 0, 24) | 10 | ||||||
| Placebo | 10 | ||||||
| IPCAVD-003 | DAIDS | Ad26.ENVA.01 | Completed | Phase 1/Double-blind (observer-blind)/Randomized/Healthy adults (Ad26 seronegative and Ad26 seropositive)/US | 5 × 1010 vp Ad26.ENVA.01 (Week 0) | 18 |
NCT01103687 [30] |
| Placebo | 6 | ||||||
| IPCAVD-004 | IAVI | Ad26.ENVA.01 Ad35.ENV |
Completed | Phase 1/Double-blind (observer-blind)/Randomized/Healthy adults/US, Kenya, Rwanda, South Africa | 5 × 1010 vp Ad26.ENVA.01 (Month 0) 5 × 1010 vp Ad35.ENV (Month 6) |
10 |
NCT01215149 [31] |
| 5 × 1010 vp Ad35.ENV (Month 0) 5 × 1010 vp Ad26.ENVA.01 (Month 6) |
10 | ||||||
| 5 × 1010 vp Ad26.ENVA.01 (Month 0) 5 × 1010 vp Ad35.ENV (Month 3) |
42 | ||||||
| 5 × 1010 vp Ad35.ENV (Month 0) 5 × 1010 vp Ad26.ENVA.01 (Month 3) |
42 | ||||||
| 5 × 1010 vp Ad26.ENVA.01 (Month 0) 5 × 1010 vp Ad26.ENVA.01 (Month 3) |
32 | ||||||
| 5 × 1010 vp Ad35.ENV (Month 0) 5 × 1010 vp Ad35.ENV (Month 3) |
32 | ||||||
| Placebo | 44 | ||||||
| HIV-V-A004 | Janssen | Ad26.Mos.HIV | Ongoing* | Phase 1/2a/Double-blind/Randomized/Healthy adults/US, Thailand, Rwanda, Uganda, South Africa | 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos.HIV+ 250 mcg gp140 + adjuvant (Weeks 24, 48) |
50 |
NCT02315703 [32] |
| 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos.HIV+ 50 mcg gp140 + adjuvant (Weeks 24, 48) |
50 | ||||||
| 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos.HIV+ placebo (Weeks 24, 48) |
50 | ||||||
| 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 108 pfu MVA-Mosaic + 250 mcg gp140 + adjuvant (Weeks 24, 48) |
50 | ||||||
| 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 108 pfu MVA-Mosaic + 50 mcg gp140 + adjuvant (Weeks 24, 48) |
50 | ||||||
| 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 108 pfu MVA-Mosaic + placebo (Weeks 24, 48) |
50 | ||||||
| 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 250 mcg gp140 + adjuvant + placebo (Weeks 24, 48) |
50 | ||||||
| Placebo (Weeks 0, 12, 24, 48) | 50 | ||||||
| VAC89220 HPX1002 | Janssen | Ad26.Mos.HIV | Ongoing† | Phase 1/Double-blind/Randomized/Healthy adults/US | 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos.HIV+ 250 mcg Clade C gp140 + adjuvant (Weeks 24, 48) |
10 | NCT02685020 |
| 5 × 1010 vp Ad26.Mos.HIV+ 250 mcg Clade C gp140 + adjuvant (Weeks 0, 12, 24) | 10 | ||||||
| 5 × 1010 vp Ad26.Mos.HIV (Week 0) 5 × 1010 vp Ad26.Mos.HIV+ 250 mcg Clade C gp140 + adjuvant (Week 8, 24) |
10 | ||||||
| Placebo | 6 | ||||||
| VAC89220HPX2003 | Janssen | Ad26.Mos4.HIV | Ongoing‡ | Phase 1/2a/Double-blind/Randomized/Healthy adults/US, Kenya, Rwanda | 5 × 1010 vp Ad26.Mos4.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos.HIV+ 250 mcg Clade C gp140 + adjuvant (Weeks 24, 48) |
25 | NCT02935686 |
| 5 × 1010 vp Ad26.Mos4.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos.HIV+ 250 mcg Clade C + Mosaic gp140 + adjuvant (Weeks 24, 48) |
100 | ||||||
| Placebo | 25 | ||||||
| VAC89220HPX2004 | Janssen | Ad26.Mos.HIV Ad26.Mos4.HIV |
Ongoing§ | Phase 1/2a/Double-blind/Randomized/Healthy adults/US, Rwanda | 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos.HIV+ 250 mcg Clade C gp140 + adjuvant (Weeks 24, 48) |
55 | NCT02788045 |
| 5 × 1010 vp Ad26.Mos4.HIV (Weeks 0, 12) 5 × 1010 vp Ad26.Mos4.HIV+ 250 mcg Clade C gp140 + adjuvant (Weeks 24, 48) |
110 | ||||||
| Placebo | 33 | ||||||
| VAC89220HTX1001 | Janssen | Ad26.Mos.HIV | Completed¶ | Phase 1/2a/Double-blind/Randomized/HIV-1 infected adults/Thailand | 5 × 1010 vp Ad26.Mos.HIV (Weeks 0, 12) 1 × 108 pfu MVA-Mosaic (Weeks 24, 48) |
18 | NCT02919306 |
| Placebo | 9 | ||||||
Cut-off for studies 21 December 2018.
* The main study has been completed; the long-term extension phase is still ongoing. Week 96 Final Analysis has been used in AdVac Safety Database.
† Week 72 Final Analysis has been used in AdVac Safety Database.
‡ Week 52 Interim Analysis was used in AdVac Safety Database.
§ The main study has been completed; the long-term extension phase is still ongoing. Week 72 Final Analysis has been used in AdVac Safety Database.
¶ Week 96 Final Analysis has been used in AdVac Safety Database.
Ad26, adenovirus serotype 26; Ad35, adenovirus serotype 35; Enva, envelope A; gp, glycoprotein; mcg, microgram; Mos, mosaic; MVA, modified vaccinia Ankara; pfu, plaque-forming units; vp, viral particles.