Clinical trial • Phase I • Infectious Disease
Clinical trial in COVID-19 prophylaxis
Phase I trial for COVID-19 prophylaxis. Authorized mRNA SARS-CoV-2 vaccines as booster; dose and schedule not specified.-controlled. 32 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- COVID-19 prophylaxis
- Trial Stage
- Phase I
- Drug Modality
- Vaccine|mRNA
Key dates
- Initial CTIS Submission Date
- 04-08-2025
- First CTIS Authorization Date
- 21-01-2026
Trial design
Authorized mRNA SARS-CoV-2 vaccines as booster; dose and schedule not specified.-controlled Phase I trial across 2 sites in France.
- Comparator
- Authorized mRNA SARS-CoV-2 vaccines as booster; dose and schedule not specified.
- Target Sample Size
- 32
Eligibility
Recruits 32 Vulnerable population not selected; participants are healthy volunteers and no special consent or assent handling is described..
- Vulnerable Population
- Vulnerable population not selected; participants are healthy volunteers and no special consent or assent handling is described.
Recruitment
- Planned Sample Size
- 32
- Recruitment Window Months
- 32
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 32
France
- Earliest CTIS Part Ii Submission Date
- 23-10-2025
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 119
- Number Of Sites
- 2
- Number Of Participants
- 32
Sites
- Site Name
- CHU Henri Mondor
- Department Name
- Service d'immunologie clinique et de maladies infectieuses
- Contact Person Name
- Jean Daniel LELIEVRE
- Contact Person Email
- jean-daniel.lelievre@aphp.fr
- Site Name
- Groupe Hospitalier Cochin Saint Vincent de Paul
- Department Name
- CIC 1417 Cochin Pasteur
- Contact Person Name
- Odile Launay
- Contact Person Email
- odile.launay@aphp.fr
Sponsor
Primary sponsor
- Full Name
- ANRS Maladies Infectieuses Emergentes
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- France
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