Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424944
Status:
UNKNOWN
Last Update Posted:
2008-04-03
First Post:
2007-01-19
Brief Title:
Safety of Recombinant Hybrid GMZ 2 GLURP MSP 3 Blood Stage Malaria Vaccine
Sponsor:
African Malaria Network Trust
Organization:
African Malaria Network Trust
Study Overview
Official Title:
A Single Centre Randomised Controlled Trial to Evaluate the Safety and Immunogenicity of Recombinant Lactococcus Lactis Hybrid GMZ 2 GLURP MSP 3 Blood Stage Malaria Vaccine Versus Rabies Vaccine in Healthy Gabonese Adult Volunteers
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
RECRUITING
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:
The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies 40 adult male Gabonese volunteers will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received They will receive 3 doses each at one month intervals and will be followed up for one year to evaluate safety parameters
This is the first time this product will be tested in Africa
This is the first time this product will be tested in Africa
Detailed Description:
Background GMZ2 is a recombinant hybrid of the Glutamate Rich Protein GLURP and the Merozoite Surface Protein 3 MSP 3This product has been developed at Sate Serum Institute in Denmark and Bacth released by Henogen of Belgium The phase Ia trial in malaria naive volunteers is currently ongoing in Germany at Tuebingen University This phase Ia trial will establish safety of the vaccine and also select the best dosage 10 30 or 100 µg The dosage with the best safety and immunogenicity profile will be recommended for the phase Ib trial in Gabon
2 Study Design This will be a single center randomized blinded and controlled study involving 40 adult male volunteers The entire study duration will be 16 months with each participant remaining 13 months in the studyThere will be 15 scheduled hospital visits and 11 scheduled field worker home visits The Rabies vaccine will be used as control vaccine
3 Objectives
- The primary objective of this trial to evaluate the safety of 3 doses of GMZ2 when administered on Days 0 28 56 adjuvanted with aluminum hydroxide in healthy Gabonese adults
- Secondary objectives include the following i To assess the humoral response to the vaccine antigens GLURP and MSP3 by measuring the antibody response by ELISA and IFA
ii To assess the cellular immune response by profiling the Th1Th2-type cytokines after 24 and 48 hours stimulation
2 Study Design This will be a single center randomized blinded and controlled study involving 40 adult male volunteers The entire study duration will be 16 months with each participant remaining 13 months in the studyThere will be 15 scheduled hospital visits and 11 scheduled field worker home visits The Rabies vaccine will be used as control vaccine
3 Objectives
- The primary objective of this trial to evaluate the safety of 3 doses of GMZ2 when administered on Days 0 28 56 adjuvanted with aluminum hydroxide in healthy Gabonese adults
- Secondary objectives include the following i To assess the humoral response to the vaccine antigens GLURP and MSP3 by measuring the antibody response by ELISA and IFA
ii To assess the cellular immune response by profiling the Th1Th2-type cytokines after 24 and 48 hours stimulation
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