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Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine

2014-08-27 03:40:34 | BioPortfolio

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

Description

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.

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 Th1/Th2-type cytokines after 24 and 48 hours stimulation.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Malaria

Intervention

GMZ2 (malaria vaccine), GMZ2 malaria vaccine, Verorab vaccine

Location

Medical Research Unit, Albert Schweitzer Hospital
Lambarene
Gabon

Status

Recruiting

Source

African Malaria Network Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:34-0400

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