NCT05226390

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

Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate Administered as Inhalation Boost in SARS-CoV-2 Immunized Adults - Phase I Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-02-24
• Primary completion: 2023-11-21
• Completion: 2023-11-21
• First posted: 2022-02-07
• Last updated: 2024-01-23

Locations

1 site across 1 country: Germany