The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium falciparum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
56
Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Biomedical Primate Research Centre
Rijswijk, Netherlands
Local and systemic reactogenicity
Time frame: Day 0-14 after each vaccination
Biological Safety
Time frame: 28 days after each vaccination
Humoral and Cellular immunogenicity
Time frame: until 365 days after the first immunisation
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