Safety, tolerability and immunogenicity of transmission-blocking vaccine Pfs230D1-EPA/Matrix-M against malaria in adults in Mali

Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person.
Eligibility:
Healthy adults (18 to 50 years of age) who reside in Sotuba and surrounding villages in Mali
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Malaria comprehension exam
Participants will be randomly assigned to get either the experimental vaccine or the approved rabies vaccine. They will not know what they are getting.
Participants will get 3 doses of the study or comparator vaccine via injection in the upper arm. This occurs at the first visit, 1 month, and 2 months later.
Participants will have up to 23 scheduled visits over 14 to 16 months. Each visit includes a physical exam, and blood will be collected at most visits.
Participants will be followed up to 1 year after the final vaccination.
If participants develop an injection site rash or reaction, photographs may be taken of the site.

Study type: Interventional
Enrollment: 80 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking : Double (Participant, Investigator)
NCT number: NCT05135273
Phase: Phase I

Clinical trial registration

Vaccines (Immune Correlates)

Oct 2021 — Jun 2023

Mali