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Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety and Immunogenicity of MVA-MERS-S_DF-1

2019-10-15 11:11:26 | BioPortfolio

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.

Study Design

Conditions

MERS (Middle East Respiratory Syndrome)

Intervention

MVA-MERS-S_DF1 - Low Dose, MVA-MERS-S_DF1 - High Dose, Placebo

Location

CTC North
Hamburg
Germany
20251

Status

Not yet recruiting

Source

Universitätsklinikum Hamburg-Eppendorf

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-15T11:11:26-0400

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