Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and immunogenicity of 3 doses and 2 vaccination schedules. This blood stage candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.
This is a double blind, randomized, controlled Phase I study of PfCp2.9, an experimental malaria vaccine candidate, adjuvanted with Montanide ISA 720. The primary objective of this study is to assess the safety and reactogenicity of the vaccine in healthy Chinese adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
70
Shanghai Changhai Hospital
Shanghai, China
To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers.
To assess the immunogenicity of the PfCP-2.9/Montanide ISA 720 vaccine in healthy adult volunteers by evaluating and comparing antigen-specific antibody responses (anti-PfCP-2.9 ELISA) after each vaccination.
For exploratory analysis:
To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA
To assess the relationship between antibody levels as measured by ELISA with the corresponding degree of in vitro parasite growth inhibition as measured by GIA
To assess antigen-specific antibody responses by IFA after each vaccination
To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite.
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