MedTrace Logo

Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19

NCT04569383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-05

No results posted yet for this study

Summary

In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine.

The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

Conditions

  • Covid19

Interventions

BIOLOGICAL

MVA-SARS-2-S vaccinations (days 0 & 28)

Vaccination with MVA-SARS-2-S in two escalating dose regimens

BIOLOGICAL

Comirnaty

Vaccination with Comirnaty (21 day interval)

Sponsors & Collaborators

  • German Center for Infection Research

    collaborator OTHER

  • Philipps University Marburg

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Marylyn M Addo, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2021-08-24
Completion
2021-08-24

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT04569383 on ClinicalTrials.gov