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

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04119440
• Collaborator: Coalition for Epidemic Preparedness Innovations (Other), IDT Biologika Dessau.Rossau (Other), German Center for Infection Research (Other), CR2O (Other), Clinical Trial Center North (CTC North GmbH & Co. KG) (Other), Erasmus Medical Center (Other)
• Enrollment: 160
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 12.5
• Patients Per Site: 80
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
MERS (Middle East Respiratory Syndrome)	Biological: MVA-MERS-S_DF1 - Low Dose; Biological: MVA-MERS-S_DF1 - High Dose; Other: Placebo	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, double-blinded with an open-label run-in Phase (Part A) Part A: Open-label Part B: Double-blindRandomized, double-blinded with an open-label run-in Phase (Part A) Part A: Open-label Part B: Double-blind
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double-blinded
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Apr 16, 2021
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose Vaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.	Biological: MVA-MERS-S_DF1 - Low Dose; Administrations of the low dose via the intramuscular route
Experimental: High Dose Vaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.	Biological: MVA-MERS-S_DF1 - High Dose; Administrations of the high dose via the intramuscular route
Placebo Comparator: Placebo Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.	Other: Placebo; Administrations of placebo via the intramuscular route

Outcome Measures

Primary Outcome Measures

1. Frequency of adverse events associated with MVA-MERS-S_DF-1. [day 1, 14, 29, 42, 56, 84, 168, 336, 364]

   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.

2. Frequency and severity of local injection site reactogenicity signs and symptoms [day 1, 14, 29, 42, 84, 336]

Secondary Outcome Measures

1. Immunogenicity [day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)]

   Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CTC North	Hamburg		Germany	20251
2	Erasmus Medical Centre	Rotterdam		Netherlands	3015

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf
• Coalition for Epidemic Preparedness Innovations
• IDT Biologika Dessau.Rossau
• German Center for Infection Research
• CR2O
• Clinical Trial Center North (CTC North GmbH & Co. KG)
• Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT04119440
• Other Study ID Numbers: CEPI-MVA-MERS-S-Phase1b
• First Posted: Oct 8, 2019
• Last Update Posted: Aug 3, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitätsklinikum Hamburg-Eppendorf: MERS-CoV; CEPI; viral vector vaccine
• Additional relevant MeSH terms: Coronavirus Infections

Study Results

No Results Posted as of Aug 3, 2021