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

Primary Purpose

MERS (Middle East Respiratory Syndrome)

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

MVA-MERS-S_DF1 - Low Dose

MVA-MERS-S_DF1 - High Dose

Placebo

About this trial

This is an interventional prevention trial for MERS (Middle East Respiratory Syndrome) focused on measuring MERS-CoV, CEPI, viral vector vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CTC North
Erasmus Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Low Dose

High Dose

Placebo

Arm Description

Vaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.

Vaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.

Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.

Outcomes

Primary Outcome Measures

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.

Frequency and severity of local injection site reactogenicity signs and symptoms

Secondary Outcome Measures

Immunogenicity

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

Full Information

NCT ID

NCT04119440

First Posted

October 6, 2019

Last Updated

November 6, 2022

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04119440

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 16, 2021 (Actual)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

MERS (Middle East Respiratory Syndrome)

Keywords

MERS-CoV, CEPI, viral vector vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blinded with an open-label run-in Phase (Part A) Part A: Open-label Part B: Double-blind

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Double-blinded

Allocation

Randomized

Enrollment

145 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Dose

Arm Type

Experimental

Arm Description

Vaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.

Arm Title

High Dose

Arm Type

Experimental

Arm Description

Vaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.

Intervention Type

Biological

Intervention Name(s)

MVA-MERS-S_DF1 - Low Dose

Intervention Description

Administrations of the low dose via the intramuscular route

Intervention Type

Biological

Intervention Name(s)

MVA-MERS-S_DF1 - High Dose

Intervention Description

Administrations of the high dose via the intramuscular route

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Administrations of placebo via the intramuscular route

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Frequency and severity of local injection site reactogenicity signs and symptoms

Time Frame

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

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

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

Time Frame

day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

CTC North

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Erasmus Medical Centre

City

Rotterdam

ZIP/Postal Code

3015

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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