NCT04497298

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

A Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed description

This is a prospective, interventional, randomized, Phase I trial comparing two different dose levels and immunization regimen of a novel COVID-19 vaccine candidate (TMV-083/V-591) against SARS-CoV-2 infection, consisting of two phases, an unblinded dose escalation and a double-blind treatment phase, to assess the safety, tolerability and immunogenicity. 90 subjects will be enrolled, 30 per cohort in three cohorts, each cohort comprising 24 vaccinees and 6 placebo recipients. Subjects will either receive two immunizations with a low dosage vaccine (Cohort A), two immunization with a high dosage vaccine (Cohort B), a single immunization with the high dosage vaccine (Cohort C) or placebo (randomized to all three cohorts). As safety precaution, the study will begin with the enrolment of a small group of 6 sentinel subjects (2 Sentinel Groups, three subjects each of cohorts A and B) each of whom will receive the vaccine on days 0 and 28 in an unblinded and non-randomized manner. Thereafter, 84 remaining participants will be enrolled in a double-blinded, randomized manner into one of the three cohorts (A, B or C). Placebo will be applied to blind the different regimen. After the screening visit, participants will be expected to return to the investigational clinical site for 8 visits (9 for the sentinel groups) up to day 91 for immunogenicity sample collection and up to day 210 for safety assessments. Samples for measles shedding will be collected from subjects of the Sentinel Groups (unblinded regiment in cohort A and B). Body fluids including saliva, nasal swab, urine and whole blood will be collected from day 0 up to day 42. The investigator and site personnel assessing Adverse Events (AEs), all participants, as well as the sponsor's representatives involved in the monitoring and conduct of the study will be unblinded to which vaccine was administered within the unblinded treatment phase. Only the site personnel performing randomization, preparation and administration of Investigational Medicinal Product (IMP) will be unblinded within the randomized double-blinded treatment phase.

Conditions

• COVID-19

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-08-10
• Primary completion: 2021-05-12
• Completion: 2021-05-12
• First posted: 2020-08-04
• Last updated: 2022-02-18

Locations

2 sites across 2 countries: Belgium, France