NCT04119440: MVA-MERS-S

Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS

Completed Phase 1 Last updated 24 April 2025

What this trial tests

Phase 1 trial testing MVA-MERS-S_DF1 - Low Dose in MERS (Middle East Respiratory Syndrome) in 145 participants. Completed in 6 November 2024.

Timeline

16 April 2021

Primary endpoint
28 November 2022

6 November 2024

Quick facts

Lead sponsor	Universitätsklinikum Hamburg-Eppendorf
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	145
Start date	16 April 2021
Primary completion	28 November 2022
Estimated completion	6 November 2024
Sites	2 locations across Netherlands, Germany

Drugs / interventions tested

• MVA-MERS-S_DF1 - Low Dose — full drug profile →
• MVA-MERS-S_DF1 - High Dose — full drug profile →
• Placebo

Conditions studied

• MERS (Middle East Respiratory Syndrome) — all drugs for MERS (Middle East Respiratory Syndrome) →

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

Adults 18 to 55, any sex, with MERS (Middle East Respiratory Syndrome). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S\_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S\_DF-1 the data will be compared to a placebo control group.

Publications & conference data

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

1. Coronavirus vaccine development: from SARS and MERS to COVID-19.
   Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2
2. COVID-19 Coronavirus Vaccine Design Using Reverse Vaccinology and Machine Learning.
   Ong E, Wong MU, Huffman A, He Y. · · 2020 · cited 241× · PMID 32719684 · DOI 10.3389/fimmu.2020.01581
3. Viral vector-based gene therapies in the clinic.
   Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258
4. SARS-CoV-2, Covid-19, and the debunking of conspiracy theories.
   Hakim MS. · · 2021 · cited 32× · PMID 33586302 · DOI 10.1002/rmv.2222
5. Coronavirus in human diseases: Mechanisms and advances in clinical treatment.
   Lin P, Wang M, Wei Y, Kim T, et al · · 2020 · cited 21× · PMID 33173860 · DOI 10.1002/mco2.26
6. Increased neutralization and IgG epitope identification after MVA-MERS-S booster vaccination against Middle East respiratory syndrome.
   Fathi A, Dahlke C, Krähling V, Kupke A, et al · · 2022 · cited 16× · PMID 35853863 · DOI 10.1038/s41467-022-31557-0
7. Safety, immunogenicity, and optimal dosing of a modified vaccinia Ankara-based vaccine against MERS-CoV in healthy adults: a phase 1b, double-blind, randomised placebo-controlled clinical trial.
   Raadsen MP, Dahlke C, Fathi A, Hardtke S, et al · · 2025 · cited 11× · PMID 39389076 · DOI 10.1016/s1473-3099(24)00423-7
8. Safety and immunogenicity of the ChAdOx1, MVA-MERS-S, and GLS-5300 DNA MERS-CoV vaccines.
   Kandeel M, Morsy MA, Abd El-Lateef HM, Marzok M, et al · · 2023 · cited 6× · PMID 37004348 · DOI 10.1016/j.intimp.2023.109998