NCT05226390

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

Terminated Phase 1 Last updated 23 January 2024

What this trial tests

Phase 1 trial testing MVA-SARS-2-ST in COVID-19 Vaccines in 23 participants. Terminated before completion.

Timeline

24 February 2022

Primary endpoint
21 November 2023

21 November 2023

Quick facts

Lead sponsor	Hannover Medical School
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	23
Start date	24 February 2022
Primary completion	21 November 2023
Estimated completion	21 November 2023
Sites	1 location across Germany

Drugs / interventions tested

• MVA-SARS-2-ST — full drug profile →

Conditions studied

• COVID-19 Vaccines — all drugs for COVID-19 Vaccines →

Sponsor

Hannover Medical School

Who can join

Adults 18 to 60, any sex, with COVID-19 Vaccines. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Mucoadhesion and Mucopenetration in the Immune Response Induced by Polymer-Based Mucosal Adjuvants.
   Vasquez-Martínez N, Guillen D, Moreno-Mendieta SA, Sanchez S, et al · · 2023 · cited 26× · PMID 37050229 · DOI 10.3390/polym15071615
2. Highly Attenuated Poxvirus-Based Vaccines Against Emerging Viral Diseases.
   Perdiguero B, Pérez P, Marcos-Villar L, Albericio G, et al · · 2023 · cited 22× · PMID 37301278 · DOI 10.1016/j.jmb.2023.168173
3. SARS-CoV-2: Immunity, Challenges with Current Vaccines, and a Novel Perspective on Mucosal Vaccines.
   Sunagar R, Singh A, Kumar S. · · 2023 · cited 21× · PMID 37112761 · DOI 10.3390/vaccines11040849
4. Recent advances in respiratory immunization: A focus on COVID-19 vaccines.
   He X, Chen X, Wang H, Du G, et al · · 2023 · cited 20× · PMID 36787821 · DOI 10.1016/j.jconrel.2023.02.011
5. MVA-based vaccine candidates encoding the native or prefusion-stabilized SARS-CoV-2 spike reveal differential immunogenicity in humans.
   Mayer L, Weskamm LM, Fathi A, Kono M, et al · · 2024 · cited 9× · PMID 38278816 · DOI 10.1038/s41541-023-00801-z
6. Rapid Development of Modified Vaccinia Virus Ankara (MVA)-Based Vaccine Candidates Against Marburg Virus Suitable for Clinical Use in Humans.
   Tscherne A, Kalodimou G, Kupke A, Rohde C, et al · · 2024 · cited 4× · PMID 39771978 · DOI 10.3390/vaccines12121316
7. Phase 1 Study of Safety, Reactogenicity, and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate Administered as Inhalation Boost in SARS-CoV-2 Immunized Adults
   Hohlfeld JM, Hammerschmidt S, Kayser T, Kutschenko A, et al · · 2025 · cited 1× · DOI 10.1101/2025.10.07.25337492
8. Systems Vaccinology Reveals Distinct Immune Signatures of Inhaled and Intramuscular SARS-CoV-2 Vaccination in Humans
   Riemann L, Hammerschmidt S, Gutierrez Jauregui R, Odak I, et al · · 2025 · DOI 10.1101/2025.10.14.25337996