NCT03333538 is a Phase 1, PHASE2 clinical trial of GamEvac-Lyo (component A) in Healthy Volunteers, sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.

What drugs are being tested in NCT03333538?

Interventions in NCT03333538: GamEvac-Lyo (component A), Placebo, GamEvac-Lyo (component B), GamEvac-Lyo.

What condition does NCT03333538 study?

NCT03333538 studies Healthy Volunteers.

Is NCT03333538 still recruiting?

NCT03333538 is currently completed. Last updated 14 November 2019.

Last reviewed 2019-11-14 · How we verify

NCT03333538

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo

Completed Phase 1, PHASE2 Last updated 14 November 2019

What this trial tests

Phase 1, PHASE2 trial testing GamEvac-Lyo (component A) in Healthy Volunteers in 220 participants. Completed in 31 December 2018.

Timeline

3 November 2017

Primary endpoint
30 November 2018

31 December 2018

Quick facts

Lead sponsor	Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	220
Start date	3 November 2017
Primary completion	30 November 2018
Estimated completion	31 December 2018
Sites	1 location across Russia

Drugs / interventions tested

GamEvac-Lyo (component A) — full drug profile →
Placebo
GamEvac-Lyo (component B) — full drug profile →
GamEvac-Lyo — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Ebola: Lessons on Vaccine Development.
Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
Membrane Microvesicles as Potential Vaccine Candidates.
Shkair L, Garanina EE, Stott RJ, Foster TL, et al · · 2021 · cited 10× · PMID 33498909 · DOI 10.3390/ijms22031142

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation trials

Trials by the same sponsor.

NCT06815549 — An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of · Phase 3 · not yet recruiting
NCT06135350 — Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial B · Phase 2 · recruiting
NCT06162975 — The Surveillance Clinical Study of Rickettsiosis · recruiting
NCT05248373 — Safety, Tolerability and Immunogenicity of Gam-COVID-Vac Vaccine in a Nasal Spray · Phase 1, PHASE2 · unknown
NCT04954092 — Study of Gam-COVID-Vac in Adolescents · Phase 2, PHASE3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03333538 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Last refreshed: 14 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03333538.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing