Trials / Completed
CompletedNCT04569383
Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19
An Open, Single-center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-SARS-2-S and Heterologous Booster Vaccinations With a Licensed Vaccine Against COVID-19
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.
Detailed description
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S). A total of 30 participants will receive the following vaccine regime: 15 participants will receive 10\^7 infectious units (IU) of MVA-SARS-2-S on days 0 and 28. 15 participants will receive 10\^8 IU of MVA-SARS-2-S on days 0 and 28. Safety and immunogenicity data will be collected throughout the study, which concludes at day 168. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. Vaccinees will receive two doses of the Comirnaty vaccine (21 days interval).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MVA-SARS-2-S vaccinations (days 0 & 28) | Vaccination with MVA-SARS-2-S in two escalating dose regimens |
| BIOLOGICAL | Comirnaty | Vaccination with Comirnaty (21 day interval) |
Timeline
- Start date
- 2020-10-05
- Primary completion
- 2021-08-24
- Completion
- 2021-08-24
- First posted
- 2020-09-29
- Last updated
- 2021-11-05
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04569383. Inclusion in this directory is not an endorsement.