Clinical pharmacology study to assess safety and immunogenicity of BK-SE36/CpG malaria vaccine in healthy Japanese adult males

This clinical trial is a BK-SE36 falciparum malaria vaccine prepared by adding aluminum hydroxide gel to the recombinant protein SE36 derived from the erythroid stage P. falciparum, and a CpG-ODN (K3) nucleic acid adjuvant prepared at the time of use. -SE36/CpG is an investigator-initiated clinical trial in which a first-in-human administration trial will be conducted in healthy Japanese adult males to explore the safety and efficacy of this drug.

Study type: Interventional
Enrollment: 26 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking : Single
Trial number: jRCT2090220109
Phase: Phase I

JRCT registration

Vaccines

Jan 2013 — Feb 2015

Japan