Clinical trial • Phase I • Infectious Disease
Coadministration of GA2 Sporozoites With Adjuvants (CoGA) for Falciparum malaria
Phase I trial of Coadministration of GA2 Sporozoites With Adjuvants (CoGA) for Falciparum malaria. 66 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Falciparum malaria
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 11-10-2024
- First CTIS Authorization Date
- 12-11-2024
Trial design
Phase I trial across 1 site in Netherlands.
- Target Sample Size
- 66
- Trial Duration For Participant
- 1581
Eligibility
Recruits 66 No vulnerable population selected; trial population described as "Healthy volunteers" and isVulnerablePopulationSelected=false in the record; no specific consent/assent handling for vulnerable groups is described..
- Vulnerable Population
- No vulnerable population selected; trial population described as "Healthy volunteers" and isVulnerablePopulationSelected=false in the record; no specific consent/assent handling for vulnerable groups is described.
Recruitment
- Planned Sample Size
- 66
- Recruitment Window Months
- 51
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 66
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-11-2024
- Latest Decision Or Authorization Date
- 04-09-2025
- Processing Time Days
- 297
- Number Of Sites
- 1
- Number Of Participants
- 66
Sites
- Site Name
- LUMC
- Department Name
- LUCID
- Principal Investigator Name
- Meta Roestenberg
- Principal Investigator Email
- m.roestenberg@lumc.nl
- Contact Person Name
- Meta Roestenberg
- Contact Person Email
- m.roestenberg@lumc.nl
- Number Of Participants
- 66
Sponsor
Primary sponsor
- Full Name
- Leids Universitair Medisch Centrum (LUMC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Coadministration of GA2 Sporozoites With Adjuvants (CoGA)
- Modality
- Vaccine
- Combination Treatment
- Yes
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