Last Updated: 04/05/2024
Safety, tolerability and immunogenicity of transmission-blocking vaccine Pfs230D1-EPA/Matrix-M against malaria in adults in Mali
Objectives
The aim of this study is to assess in African adults the safety of and immune response to the administration of Pfs230D1-EPA/Matrix-M vaccine as compared to the rabies vaccine control.
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
Article: A human monoclonal antibody blocks malaria transmission and defines a highly conserved neutralizing epitope on gametesArticle: Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial
Related Resources
