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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Completed; Phase 1

Conditions: MERS (Middle East Respiratory Syndrome)

Treatments: Biological: MVA-MERS-S_DF1 - High Dose; Biological: MVA-MERS-S_DF1 - Low Dose; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04119440

CEPI-MVA-MERS-S-Phase1b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 3 patient groups, including a placebo group

Low Dose

Experimental group

Description:

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

Treatment:

Biological: MVA-MERS-S_DF1 - Low Dose

High Dose

Experimental group

Description:

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

Treatment:

Biological: MVA-MERS-S_DF1 - High Dose

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo