NCT04895449

Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19

A Multi-center Phase Ib Trial to Assess the Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST in Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).

Detailed description

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized SARS-CoV-2 spike protein (S). This will be a phase Ib multi-center study in approximately 60 adults aged 18-64 years. Part A (N=24 seronegative subjects). Each participant will receive two single injections, 28 days apart. * low dose ≥ 1 x 10e7 IU (N=8) * middle dose ≥ 5 x 10e7 IU (N=8) * high dose ≥ 1 x 10e8 IU (N=8) Part B (N=36 previously mRNA vaccinated subjects). Each participant will receive a single injection. * low dose ≥ 1 x 10e7 IU (N=12) * middle dose ≥ 5 x 10e7 IU (N=12) * high dose ≥ 1 x 10e8 IU (N=12) All participants will be followed up for safety until D168.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	MVA-SARS-2-ST	i.m. vaccine administration

Timeline

• Start date: 2021-07-16
• Primary completion: 2022-11-02
• Completion: 2022-11-08
• First posted: 2021-05-20
• Last updated: 2023-01-18

Locations

2 sites across 1 country: Germany