CompletedPhase 1

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

Germany, Netherlands145 participantsStarted 2021-04-16

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Written informed consent form.
✓. Healthy male and female subjects aged 18-55 years.
✓. No clinically significant acute health problems as determined from medical history and physical examination at screening visit.
✓. Body mass index 18.5 - 30.0 kg/m2 and weight \> 50 kg at screening.
✓. Non-pregnant, non-lactating female with negative pregnancy test.
✓. Males and females who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion criteria

✕. Receipt of any vaccine from 2 weeks prior to each trial vac-cination (4 weeks for live vaccines) to 3 weeks after each trial vaccination.
✕. Receipt of vaccination against MERS or MVA immunizations.in the medical history.
✕. Known allergy to the components of the MVA-MERS-S\_DF-1 vaccine product.
✕. Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product.
✕. Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
✕. Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

What they're measuring

Frequency of adverse events associated with MVA-MERS-S_DF-1.

Timeframe: day 1, 14, 29, 42, 56, 84, 168, 336, 364

Frequency and severity of local injection site reactogenicity signs and symptoms

Timeframe: day 1, 14, 29, 42, 84, 336

Trial details

NCT IDNCT04119440

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-28

View on ClinicalTrials.gov More MERS (Middle East Respiratory Syndrome) trials