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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