Clinical trial • Phase III • Infectious Disease

PfSPZ-LARC2 Vaccine for Malaria

Phase III trial of PfSPZ-LARC2 Vaccine for Malaria. 42 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Malaria
Trial Stage
Phase III
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
04-12-2025
First CTIS Authorization Date
26-01-2026

Trial design

Phase III trial across 1 site in Germany.

Target Sample Size
42

Eligibility

Recruits 42 Vulnerable population not selected; trial population described as healthy adult volunteers. No vulnerable population consent/assent handling is described in the available record..

Vulnerable Population
Vulnerable population not selected; trial population described as healthy adult volunteers. No vulnerable population consent/assent handling is described in the available record.

Recruitment

Planned Sample Size
42
Recruitment Window Months
3
Consent Approach
Informed consent to be provided by adult participants. Trial enrols healthy adults; no vulnerable population or assent procedures described. Languages or age-specific consent documents not specified in the available record.

Geography

Total Number Of Sites
1
Total Number Of Participants
42

Germany

Earliest CTIS Part Ii Submission Date
01-12-2025
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
114
Number Of Sites
1
Number Of Participants
42

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Internal Medicine VII
Principal Investigator Name
Peter Kremsner
Principal Investigator Email
peter.kremsner@uni-tuebingen.de
Contact Person Name
Peter Kremsner
Number Of Participants
42

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
PfSPZ-LARC2 Vaccine
Modality
Vaccine

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