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

MERS (Middle East Respiratory Syndrome) Clinical Trial

— MVA-MERS-S  

Official title:

A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04119440
• Other study ID #: CEPI-MVA-MERS-S-Phase1b
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 16, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 years

The study is separated in two parts:

Part A:

The study starts with a single center open-label run-in phase of two dose levels (cohort 1 "low dose": 2x10^7 PFU, cohort 2 "high dose": 2x10^8 PFU) in 10 healthy subjects. 5 subjects will be allocated to each dose cohort and will receive immunization on day 0 and day 28.

Part B:

Two-center, randomized, double-blind, placebo-controlled, dose-finding study. This part is a double-blinded trial in approximately 150 healthy subjects. Subjects will be allocated to two different dose cohorts and a placebo cohort; each receiving three vaccine injections.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: May 30, 2024
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Written informed consent form.

2. Healthy male and female subjects aged 18-55 years.

3. No clinically significant acute health problems as determined from medical history and physical examination at screening visit.

4. Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening.

5. Non-pregnant, non-lactating female with negative pregnancy test.

6. Males and females who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion Criteria:

1. 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.

2. Receipt of vaccination against MERS or MVA immunizations.in the medical history.

3. Known allergy to the components of the MVA-MERS-S_DF-1 vaccine product.

4. 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.

5. Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.

6. Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Related Conditions & MeSH terms

• Coronavirus Infections
• MERS (Middle East Respiratory Syndrome)

Intervention

Biological:
• MVA-MERS-S_DF1 - Low Dose
Administrations of the low dose via the intramuscular route
• MVA-MERS-S_DF1 - High Dose
Administrations of the high dose via the intramuscular route

Other:
• Placebo
Administrations of placebo via the intramuscular route

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Netherlands	Erasmus Medical Centre	Rotterdam

Sponsors (7)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Coalition for Epidemic Preparedness Innovations, CR2O, Erasmus Medical Center, German Center for Infection Research, IDT Biologika Dessau.Rossau, Monipol Deutschland GmbH

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events associated with MVA-MERS-S_DF-1.	Safety and reactogenicity will be assesssed by observation, questionaire and diary. Changes from baseline for safety laboratory measures will be monitored. Occurence of SAE will be collected throughout the entire study duration.	day 1, 14, 29, 42, 56, 84, 168, 336, 364
Primary	Frequency and severity of local injection site reactogenicity signs and symptoms		day 1, 14, 29, 42, 84, 336
Secondary	Immunogenicity	Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory	day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)