A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
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.
Prophylaxis Against Plasmodium Falciparum Malaria
Biological: Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Ph-1 Double-Blind Randomized Control Study-Evaluate Safety & Immunogenicity of Wanxing Bio-Pharmaceuticals AMA-1/MSP-1 Recombinant Malaria Vaccine (PfCP-2.9) Adj. w/ Montanide ISA 720 Compared to Montanide ISA 720 Alone in Adult Volunteers|
- 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.
|Study Start Date:||January 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284973
|Shanghai Changhai Hospital|
|Principal Investigator:||Jinhong Hu, Dr.||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|