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Study of Safety and Immunogenicity of BVRS-GamVac-Combi

NCT04128059 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2021-01-14

No results posted yet for this study

Summary

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of \~34.5%.

The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.

Conditions

  • MERS (Middle East Respiratory Syndrome)
  • MERS

Interventions

DRUG

BVRS-GamVac-Combi

"BVRS-GamVac-Combi", a combined vector vaccine for the prevention of Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration

OTHER

placebo

placebo

Sponsors & Collaborators

  • Acellena Contract Drug Research and Development

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Tatiana Zubkova, MD, PhD · ECO-Safety

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2021-07-01
Completion
2021-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04128059 on ClinicalTrials.gov