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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: MERS (Middle East Respiratory Syndrome)
• Intervention / Treatment: Biological: MVA-MERS-S_DF1 - Low Dose; Biological: MVA-MERS-S_DF1 - High Dose; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Frequency and severity of local injection site reactogenicity signs and symptoms		day 1, 14, 29, 42, 84, 336

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Erasmus Medical Center; German Center for Infection Research; Coalition for Epidemic Preparedness Innovations; CR2O; IDT Biologika Dessau.Rossau; Monipol Deutschland GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): November 28, 2022
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: October 6, 2019
• First Submitted That Met QC Criteria: October 6, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MERS-CoV; CEPI; viral vector vaccine
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: CEPI-MVA-MERS-S-Phase1b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No