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Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine

NCT04497298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-02-18

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083/V-591).

Conditions

Interventions

BIOLOGICAL

Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose

Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2)

BIOLOGICAL

Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose

Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2)

BIOLOGICAL

One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose

Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2) and placebo

OTHER

Placebo

Physiological saline solution (0.9% NaCl)

Sponsors & Collaborators

  • Themis Bioscience GmbH

    collaborator INDUSTRY

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Christiane GERKE, PhD · Institut Pasteur

  • Odile LAUNAY, MD, PhD · CIC 1417 Cochin-Pasteur

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2021-05-12
Completion
2021-05-12

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT04497298 on ClinicalTrials.gov