Table 1.
Summary of Phase I clinical trials of vaccines for EVD. vp, viral particles; pfu, plaque-forming units.
vaccine type | vaccine(s) | clinical trials.gov identifier | vaccination start month | dose(s) used | regimen | site | N | references |
---|---|---|---|---|---|---|---|---|
DNA vaccine | VRC-EBODNA012-00-VP-DNA: 3-plasmid (transmembrane-deleted EBOV GP, SUDV GP, nucleoprotein) | NCT00072605 | November 2003 | 2, 4 or 8 mg | three doses at weeks 0, 4, 8 | MD, USA | 27 (5, 8, 8 + 6 placebos) | [13] |
replication-deficient viral vectors | rAdHu5 EBOV and SUDV GP with single point mutation in GP (asp- > glu at position 71) | NCT00374309 | September 2006 | 2 × 109 vp, 2 × 1010 vp | single dose | MD, USA | 31 (12, 11 + 8 placebo) | [14] |
DNA vaccine | VRC-EBODNA023-00-VP 2 plasmids—SUDV and EBOV GPs with a Marburg DNA vaccine (full-length WT GP) | NCT00605514 | January 2008 | 4 mg | three doses at weeks 0, 4, 8, fourth dose boost at 32 weeks | MD, USA | 20 | [15] |
DNA vaccine | VRC-EBODNA023-00-VP 2 plasmids—SUDV and EBOV GPs with a Marburg DNA vaccine (full-length WT GP) | NCT00997607 | November 2009 | 4 mg | three doses at weeks 0, 4, 8 | Kampala, Uganda | 30 EBOV vaccine, 30 Marburg vaccine, 30 both concomitantly | [16] |
replication-deficient viral vectors | mixture of ChAd3 EBOV and SUDV GP | NCT02231866 | September 2014 | 1 × 1010 vp, 1 × 1011 vp | single dose | MD, USA | 20 (10 per dose) | [17] |
replication-deficient viral vector | ChAd3 EBOV GP | NCT02240875 | September 2014 | 1 × 1010 vp, 2.5 × 1010 vp, 5 × 1010 vp | single dose | Oxford, UK | 60 (20 per dose) | [18] |
replication-deficient viral vectors | ChAd3 EBOV GP and MVA-BN Filo | NCT02240875 | September 2014 | ChAd3 at: 1 × 1010 vp, 2.5 × 1010 vp, 5 × 1010 vp MVA at: 1.5 × 108, 3 × 108 pfu |
ChAd3 at D0, MVA at 3–10 weeks, 1 week or 2 weeks |
Oxford, UK | 30 (15 each dose), split across the ChAd3 dose groups | [18] |
live replicating viral vaccine | rVSV-ZEBOV |
NCT02269423 NCT02280408 |
October 2014 | 3 × 106, 2 × 107 pfu | single dose | Washington DC, Baltimore MD, USA |
52 (26 at each site, 10 + 3 placebos in each dose group) | [19] |
replication-deficient viral vector | ChAd3 EBOV GP | NCT02289027 | October 2014 | 2.5 × 1010 vp, 5 × 1010 vp | single dose | Lausanne, Switzerland | 120 (100 vaccinees, 20 placebo) | [18,20] |
replication-deficient viral vector | ChAd3 EBOV GP | NCT02267109 | October 2014 | 1 × 1010 vp, 2.5 × 1010 vp, 5 × 1010 vp, 1 × 1011 vp | ChAd3 at D0, MVA at 11–16 weeks | Bamako, Mali | 91 | [21] |
live replicating viral vaccine | rVSV-ZEBOV |
NCT02296983 NCT02283099 NCT02287480 |
November 2014 | 3 × 105, 3 × 106, 1 × 107, 2 × 107, 5 × 107 pfu | single dose | Kilifi, Kenya; Hamburg, Germany; Geneva, Switzerland |
158 | [22] |
replication-deficient viral vectors | AdHu26 EBOV GP and MVA-BN Filo | NCT02313077 | December 2014 | ChAd3 at 5 × 1010 vp MVA at 1 × 108 |
Chad3 or MVA at D0, heterologous boosting at 2, 4 or 8 weeks | Oxford, UK | 87 (75 vaccinees and 12 placebo) | [23] |
replication-deficient viral vector | rAdHu5 encoding EBOV GP from 2014 outbreak strain | NCT02326194 | December 2014 | 4 × 1010 vp, 1.6 × 1011 vp | single dose | Jiangsu, China | 120 (40 low dose, 40 high dose, 40 placebo) | [24] |
live replicating viral vaccine | rVSV-ZEBOV | NCT02287480 | January 2015 | 3 × 105 pfu | single dose | Geneva, Switzerland | 56 (51 vaccinees and 5 placebo) | [25] |