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Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate

NCT05226390 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-01-23

No results posted yet for this study

Summary

This will be a phase I, single-center trial, including a total of 30 participants in two cohorts.

Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen.

Cohort 2 (n=24): Healthy male or female adults aged 18 - ≤ 60 primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen and subsequently booster immunized with any EU marketed mRNA vaccine

Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST

Conditions

  • COVID-19 Vaccines

Interventions

BIOLOGICAL

MVA-SARS-2-ST

In this trial MVA-SARS-2-ST will be used. Each vial contains 1 x 107 IU/dose MVA-SARS-2-ST in 0.5 mL as active ingredient. The solution will be used for nebulization and direct administration to the respiratory tract.

Sponsors & Collaborators

  • German Center for Infection Research

    collaborator OTHER

  • IDT Biologika

    collaborator UNKNOWN

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Jens Hohlfeld, Prof. · Hannover Medical School, Department of Respiratory Medicine and Fraunhofer ITEM, Division of Clinical Airway Research

  • Reinhold Förster, Prof. · Hannover Medical School Institute of Immunology

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2023-11-21
Completion
2023-11-21

Countries

  • Germany

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 NCT05226390 on ClinicalTrials.gov