Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine
|ClinicalTrials.gov Identifier: NCT00424944|
Recruitment Status : Unknown
Verified April 2008 by African Malaria Network Trust.
Recruitment status was: Recruiting
First Posted : January 22, 2007
Last Update Posted : April 3, 2008
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
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Biological: GMZ2 (malaria vaccine) Biological: GMZ2 malaria vaccine Biological: Verorab vaccine||Phase 1|
Background. GMZ2 is a recombinant hybrid of the Glutamate Rich Protein (GLURP) and the Merozoite Surface Protein 3 (MSP 3).This 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 study.There will be 15 scheduled hospital visits and 11 scheduled field worker home visits. The Rabies vaccine will be used as control vaccine.
- 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 Th1/Th2-type cytokines after 24 and 48 hours stimulation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||July 2008|
|Estimated Study Completion Date :||August 2008|
Experimental: I, GMZ2 vaccine arm
20 volunteers will receive GMZ2 vaccine on days 0, 28, and 56
Biological: GMZ2 (malaria vaccine)
100 micrograms of GMZ2 in each vaccinationBiological: GMZ2 malaria vaccine
100 micrograms of GMZ2Biological: Verorab vaccine
Active Comparator: II, Rabies vaccine arm
20 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56
Biological: GMZ2 (malaria vaccine)
100 micrograms of GMZ2 in each vaccinationBiological: Verorab vaccine
- Local and systemic reactogenicity [ Time Frame: 28 days following each immunization ]
- Unsolicited adverse events [ Time Frame: 1 year ]
- Occurrence of serious adverse events [ Time Frame: 1 year ]
- Biological safety [ Time Frame: 1 year ]
- Humoral immune response to GLURP and MSP 3 [ Time Frame: 1 year ]
- Cellural immune response [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424944
|Contact: Saadoul Issifou, MD, PhD||+241 email@example.com|
|Contact: Saadou Issifou, MD, PhD||+241 firstname.lastname@example.org|
|Medical Research Unit, Albert Schweitzer Hospital||Recruiting|
|Principal Investigator: Michel Missinou, PhD|
|Sub-Investigator: Saadou Issifou, MD, PhD|
|Study Director:||Peter Kremsner, MD, PhD||Medical research Unit, Albert Schweitzer Hospital|