This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The study duration shall be 34 months and subject participation duration shall be 15-26 months.
This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this study is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The secondary objective is to evaluate vaccine-induced anti-CSP antibody immune responses. The study duration shall be 34 months and subject participation duration shall be 15-26 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
112
Four tablets of 50mg each, totaling 200mg will be given in a single calendar day
PfSPZ is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
Placebo
Centre National de Recherche et de Formation sur le Paludisme - Research and Training
Ouagadougou, Kadiogo, Burkina Faso
Occurrence of Grade 3 unsolicited adverse events (AEs) considered related to vaccination
Time frame: Day 1 through Day 28
Occurrence of Grade 3 unsolicited adverse events (AEs) considered related to vaccination
Time frame: Day 57 through Day 83
Occurrence of serious adverse events (SAEs) at any point during the study period
Time frame: Day 1 through Day 645
Occurrence of serious adverse events (SAEs) considered related to vaccination
Time frame: Day 1 through Day 28
Occurrence of serious adverse events (SAEs) considered related to vaccination
Time frame: Day 57 through Day 83
Occurrence of solicited reactions
Time frame: Day 1 through Day 8
Occurrence of solicited reactions
Time frame: Day 57 through Day 64
Antibody titers against P. falciparum circumsporozoite protein (CSP) at serology time points
Time frame: Day 1 through Day 127
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