Clinical trial • Phase I/II • Infectious Disease
Orf virus-based COVID-19 vaccine for COVID-19|SARS-CoV-2 infection
Phase I/II trial of Orf virus-based COVID-19 vaccine for COVID-19|SARS-CoV-2 infection. 96 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- COVID-19|SARS-CoV-2 infection
- Trial Stage
- Phase I/II
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 11-03-2024
- First CTIS Authorization Date
- 26-03-2024
Trial design
Phase I/II trial across 2 sites in Germany.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 96
Eligibility
Recruits 96 isVulnerablePopulationSelected = true is indicated in the registry, but no detailed vulnerable population, consent or assent handling information is provided in the available record..
- Vulnerable Population
- isVulnerablePopulationSelected = true is indicated in the registry, but no detailed vulnerable population, consent or assent handling information is provided in the available record.
Recruitment
- Planned Sample Size
- 96
- Recruitment Window Months
- 54
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 96
Germany
- Earliest CTIS Part Ii Submission Date
- 26-01-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 808
- Number Of Sites
- 2
- Number Of Participants
- 96
Sites
- Site Name
- Bernhard-Nocht-Institut Fuer Tropenmedizin
- Department Name
- Clinical Research Department
- Contact Person Name
- Johanna Fischer-Herr
- Contact Person Email
- studien@bnitm.de
- Site Name
- Eberhard Karls Universitaet Tuebingen
- Department Name
- Institute of Tropical Medicine
- Contact Person Name
- Meral Esen
- Contact Person Email
- ITMPM@med.uni-tuebingen.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Tuebingen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Prime-2-CoV_Beta
- Active Substance
- Orf virus-based COVID-19 vaccine
- Modality
- Vaccine
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