Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety and Immunogenicity of MVA-MERS-S_DF-1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04119440|
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
|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|
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:
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.
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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|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-blind|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
Administrations of placebo via the intramuscular route
- Frequency of adverse events associated with MVA-MERS-S_DF-1. [ Time Frame: 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.
- Frequency and severity of local injection site reactogenicity signs and symptoms [ Time Frame: day 1, 14, 29, 42, 84, 336 ]
- Immunogenicity [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119440
|Contact: Marylyn M Addo, Prof||+49 40 7410 email@example.com|
|Contact: Eric van Gorp, Prof||+31 10 firstname.lastname@example.org|
|Hamburg, Germany, 20251|
|Contact: Marylyn M Addo, Prof email@example.com|
|Contact: Alen Jambrecina, MD firstname.lastname@example.org|
|Erasmus Medical Centre|
|Rotterdam, Netherlands, 3015|
|Contact: Eric van Gorp, Prof email@example.com|
|Contact: Matthijs Raadsen, MD firstname.lastname@example.org|