Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284973
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2006-01-30
Brief Title:
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
Sponsor:
Shanghai Wanxing Bio-Pharmaceutical Co Ltd
Organization:
PATH
Study Overview
Official Title:
Ph-1 Double-Blind Randomized Control Study-Evaluate Safety Immunogenicity of Wanxing Bio-Pharmaceuticals AMA-1MSP-1 Recombinant Malaria Vaccine PfCP-29 Adj w Montanide ISA 720 Compared to Montanide ISA 720 Alone in Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate PfCP29 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 blood stage candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas
Detailed Description:
This is a double blind randomized controlled Phase I study of PfCp29 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
The primary objective of this study is to assess the safety and reactogenicity of the vaccine in healthy Chinese adult volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None