Table 2.
Summary of clinical trial programs.
| Protocol Number, Trial Name, Country Location, and Trial Registry Number |
Trial Description | [Sponsor] External Trial Partner Organization/Funders, and Academic Partners |
N Vaccinated with rVSVΔG-ZEBOV-GP | Dose Levels (pfu) |
Subject Memory Aid Use (Y/N) |
CSR MedDRA Version | AE Category | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Solicited Injection Site and Systemic AEs |
Unsolicited AEs | SAEs | Viremia and Viral Shedding |
Clinical Laboratory Safety Tests |
|||||||
| Phase 1 * | |||||||||||
| V920-001 US NCT02269423 |
Randomized single-center, double-blind, placebo-controlled, dose- escalation study [44] |
[BPS/NLG] Walter Reed Army Institute of Research/DTRA, Imperial College of Science, Technology, and Medicine; University of Maryland School of Medicine, University of Texas-Austin |
30 | 3 × 106, 2 × 107, 1 × 108
(n = 10 each) or Placebo (n = 9) |
Yes | 17.0 | Day 1–14 | Day 1–28 | Day 1–180 | Day 1, 3, 7, 14 |
Day 0, 1, 3, 7, 28, 180 |
| V920-002 US NCT02280408 |
Randomized double-blind, placebo-controlled, dose- escalation study [44] |
[BPS/NLG] NIH/NIAID |
30 | 3 × 106, 2 × 107, 1 × 108 (n = 10 each), Placebo (n = 9) † Second identical dose at D28 |
Yes | 17.0 | Day 1–14 | Day 1–28 | Day 1–365 | Day 0, 3, 7 following each dose |
Day 0, 7, 28, 35, 56 following each dose |
| V920-003 Canada NCT02374385 |
Randomized single-center, double-blind controlled, dose-ranging study [45] | [BPS/NLG] CIHR; PHAC, University of Ottawa, Dalhousie University |
30 | 1 × 105, 5 × 105, 3 × 106 (n = 10 each), Placebo (n = 10) |
Yes | 17.0 | Day 1–14 | Day 1–28 | Day 1–180 | Day 1, 3, 7, 14 |
Day 0, 1, 3, 7, 28, 180 |
| V920-004 US NCT02314923 |
Randomized multi-center, double-blind, placebo- controlled, dose-response study [34] |
[BPS/NLG] BARDA |
418 | 3 × 103, 3 × 104, 3 × 105 (n = 64 each) 3 × 106 (n = 84) 9 × 106, 2 × 107 (n = 47 each) 1 × 108 (n = 48) Placebo (n = 94) |
Yes | 17.0 | Cohort 1: Day 1–14 Cohort 2: Day 1–56 |
Cohort 1: Day 1–14 Cohort 2: Day 1–56 |
Day 1–360 | Day 0, 1, 2, 3, 4, 7, 14, 28 | Day 0, 7, 28 |
| V920-05 Switzerland NCT02287480 |
Dose-finding, randomized, single-center, double-blind †, placebo- controlled study [46] |
[University Hospitals of Geneva] WHO, Wellcome Trust, Innovative Medicines Initiative, University Hospitals of Geneva |
102 | 3 × 105
(n = 51) 1 × 107 (n = 35) 5 × 107 (n = 16) Placebo (n = 13) |
Yes | 17.0 | Day 1–14 | Day 1–28 | Day 1–365 | Day 0, 1, 3, 7 | Day 0, 1, 3, 7, 14, 28, 365 (only blood count at Day 365) |
| V920-006 Germany NCT02283099 |
Open-label, dose-escalation study [47] | [Universitätsklinikum Hamburg-Eppendorf] WHO; Wellcome Trust | 30 | 3 × 105, 3 × 106, 2 × 107 (n = 10 each) |
Yes | 17.0 | Day 1–14 | Day 1–28 | Day 1–180 | Day 0, 1 to 7, 14, 28 | Day 0, 1, 3, 7, 14, 28, 180 |
| V920-007 Gabon PACTR201411000919191 |
Randomized open-label, dose-escalation study [48] | [Universitätsklinikum Tübingen] WHO; Wellcome Trust, St. George’s University of London, Medical University Vienna, Austria |
115 ‡ | 3 × 103
(n = 20) 3 × 104 (n = 20) 3 × 105 (n = 20) 3 × 106 (n = 39) 2 × 107 (n = 16) |
Yes | 17.0 | Day 1–14 | Day 1–28 | Day 1–365 | Day 0, 1, 2, and 7 |
Day 0, 1, 2, 7, 28, 84, 180, 365 |
| V920-008 Kenya NCT02296983 |
Open-label, dose-escalation study [49] | [University of Oxford] WHO; Wellcome Trust | 40 | 3 × 106
2 × 107 (n = 20 each) |
Yes | 17.0 | Day 1–14 | Day 1–28 | Day 1–365 | Day 1, 3, 7 | Day 0, 7, 30 |
| V920-009 PREVAIL Liberia NCT02344407 |
Randomized double-blind, placebo-controlled, 3-arm trial [50] | [NIH/NIAID] Liberian Ministry of Health and Social Welfare, BARDA, GlaxoSmithKline, University of Minnesota |
500 | 2 × 107
(n = 500) GSK (n = 500) Placebo (n = 500) |
No | 20.0 | Week 1, Week 2, Month 1 ₶ | Week 1 and Month 1 | Wk 1, Month 1 and 2, every 2 Months to trial end | Not collected | At Week 1 and Month 1 |
| V920-014 Lambaréné, Gabon Not registered |
Randomized, open-label, controlled | Centre de Recherches Médicales de Lambaréné (CERMEL), |
Planned: 40 |
2 × 107 n = 40 Varicella vaccine N = 20 |
No | N/A | Days 1–28 | Days 1–28 | Days 1–365 | Days 1–56 | Screening, D7, 28, 84, 180, 365 |
| Phase 2/3 | |||||||||||
| V920-010 Ebola Ҫa Suffit Guinea PACTR201503001057193 |
Open-label, cluster-randomized ring vaccination trial [24] | [WHO] Norwegian Research Council; MSF; Wellcome Trust; PHAC, Guinea Ministry of Health and Public Hygiene |
5837 | 2 × 107 (n = 5837) |
No | N/A § | Minute 30, Day 3, and Day 14 | Day 1–14 | Day 1–84 | Not collected | Not collected |
| V920-011 STRIVE Sierra Leone NCT02378753 |
Randomized unblinded trial design [51] | [US CDC] BARDA, Sierra Leone Ministry of Health and Sanitation, College of Medicine and Allied Health Sciences—Sierra Leone |
7998 | 2 × 107
(n = 7998) |
Yes | 19.0 | Safety sub study participants: Day 0–28 | Overall pop: Day 0–28 | Overall pop: Day 0–180 | Not collected | Not collected |
| V920-012 Lot Consistency US, Canada, Spain NCT02503202 |
Randomized placebo-controlled, safety and lot consistency immunogenicity study [52] | [MSD, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA] BARDA; Dalhousie University | 1061 | 2 × 107
(n = 797) 1 × 108 (n = 264) Placebo (n = 133) |
Yes | 19.1 | Day 1–42 ¥ | Day 1 to 42 | Day 1 to Month 24 | Not collected | As needed for arthralgia, arthritis, rash or vesicles— follow-up only |
| V920-013 PREPARE US, Canada NCT02788227 |
Randomized open-label, booster or no booster at 18 months in individuals at potential occupational risk | [NIH/NIAID] BARDA, University of Texas, Galveston, TX, Emory University, PHAC, Winnipeg; CIRN, University of Nebraska Medical Center, Boston Medical Center/Boston University, Universitätsklinikum Hamburg-Eppendorf |
Planned enrollment N up to 1000 | 2 × 107 | Yes | N/A | Day 1–14, Month 1, Month 18 (booster), Month 19 (post-booster) | Day 1–42 | Day 1 to Year 3 |
Not collected | Not collected |
| V920-015 ACHIV Canada, Burkina Faso, Senegal NCT03031912 |
Randomized double-blind, placebo- controlled, one or two doses of rVSVΔG-ZEBOV-GP |
[Dalhousie University] BARDA, CIRN |
Planned enrollment ~250 | 2 × 107 pfu/mL (n~200) Placebo (n~50) |
Yes | N/A | Day 1, 3, 7, 14, 28, 42 | Day 1, 3, 7, 14, 28, 42 | Day 0–365 | Day 3, 7, 14, 28, 42 |
Only as clinically needed |
| V920-016 PREVAC Guinea, Liberia, Mali, Sierra Leone NCT02876328 |
Randomized double-blind, placebo- controlled trial of three vaccine strategies (Ad26.ZEBOV/MVA-BN-Filo vaccine-Janssen, rVSVΔG-ZEBOV-GP vaccine-MSD with or without boost at 56 days) in adults and children ≥1 year |
[Office of Clinical Research Operations and Regulatory Compliance Division of Clinical Research NIAID, NIH; Institut National de la Santé et de la Recherche Médicale; LSHTM] BARDA, MSD, Janssen, University of Minnesota |
~1822 | 2 × 107 pfu/mL, (N~1822) Also includes Janssen vaccine and placebo | No | N/A | Adults: Day 0, 7, 14, 28, 56, 63, Month 3 Children: Day 0, daily contacts, Day 1–6, Day 7, 14, 28, 56, 63, Month 3 |
Grade 3 and 4 unsolicited AEs only. Adults: Day 0, 7, 14, 28, 56, 63, Month 3 Children: Day 0, daily contacts Day 1–6, Day 7, 14, 28, 56, 63, Month 3 | Day 0-Month 12 | Subset of children: Day 0, 7, 14, 28, 56, 63, Month 3 | Adults: Day 0 Children: Day 0, 7, 63 |
| V920-018 Front-Line Workers (FLW) Guinea PACTR201503001057193 |
Open-label, cluster-randomized ring vaccination trial [53] | [WHO] University of Maryland, University of Bern, LSHTM, University of Florida |
2016 | 2 × 107(N = 2016) | No | N/A | Not collected | Day 3, 14 | Day 0–84 | Not collected | Not collected |
* All Phase I assay work was done by the United States Army Medical Research Institute of Infectious Diseases with funding from the Joint Vaccine Acquisition Program. † Participants in the V920-002 trial received two doses of rVSVΔG-ZEBOV-GP on days 0 and 28 post-vaccination. Data for participants who received the second dose are presented separately from participants who received a single dose. ‡ Additional 40 pediatric subjects also included (6–12 and 13–17 years of age, each n = 20). ₶ The V920-009 trial did not collect a specific adverse event (AE) onset date or stop date; all other trials collected AE onset and stop dates for solicited AEs. § Adverse events were not encoded using MedDRA for the V920-010 trial. ¥ Injection-site AEs were solicited from day 1 to 5 post-vaccination in the V920-012 trial; joint and skin events were solicited from day 1 to 42. No other solicited systemic AEs were collected in this trial. AE = adverse event; BARDA: Biomedical Advanced Research and Development Authority; BPS: BioProtection systems; CIRN: Canadian Immunization Research Network; CDC: Centers for Disease Control; CIHR: Canadian Institutes of Health Research; CSR: clinical study report; DTRA: Defense Threat Reduction Agency; LSHTM: London School of Hygiene and Tropical Medicine; MSF: Médecins Sans Frontières; N/A: not applicable; NIH: National Institutes of Health; NIAID: National Institute of Allergy and Infectious Diseases; NLG: NewLink Genetics Corporation; pfu: plaque-forming units; PHAC: Public Health Agency of Canada; PREVAIL: Partnership for Research on Ebola Virus in Liberia, SAE: serious adverse event; STRIVE: Sierra Leone Trial to Introduce a Vaccine Against Ebola; US: United States; WHO: World Health Organization.