Plasmodium Falciparum Malaria Clinical Trial
Official title:
A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria
The purpose of this study is to evaluate an experimental malaria vaccine for its ability to
prevent malaria infection or disease in a blood-stage challenge model (when volunteers are
infected with malaria parasites using malaria-infected red blood cells). The vaccine being
testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve
the body's response to a vaccination) called AS01B.
The aim is to use this protein and adjuvant to help the body make an immune response against
parts of the malaria parasite. This study will enable assessment of:
1. The ability of the vaccine to prevent malaria infection.
2. The safety of the vaccine in healthy participants.
3. The response of the human immune system to the vaccine.
This will be done by giving participants three vaccinations and then exposing them to
malaria infection by transfusing a small number of red blood cells infected with malaria
under carefully regulated conditions. Participants will be followed closely to observe if
and when they develop malaria. If the vaccine provides some protection against malaria,
participants will take longer to develop malaria than usual or will not develop malaria at
all.
The study will enrol 15 participants to be vaccinated and then challenged with malaria in
addition to recruit 15 individuals to be control subjects.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
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