Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years
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|ClinicalTrials.gov Identifier: NCT00703066|
Recruitment Status : Unknown
Verified November 2008 by African Malaria Network Trust.
Recruitment status was: Active, not recruiting
First Posted : June 23, 2008
Last Update Posted : November 25, 2008
The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years 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. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.
This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Biological: GMZ 2 vaccine (GLURP + MSP 3) Biological: Rabies 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 State Serum Institute/EMVI in Denmark and Batch released by Henogen of Belgium. The phase Ia trial in malaria naive volunteers was done in Germany, at Tuebingen University. This phase Ia trial established safety of the vaccine and also assisted in selecting the best dosage (10, 30 or 100 µg). The dosage with the best safety and immunogenicity profile will be tested for the phase Ib trials in Gabon, including this phase Ib trial in children.
To evaluate the safety and reactogenicity of three doses of 30 and 100µg GMZ2, adsorbed on aluminium hydroxide, in comparison with three doses of the control vaccine (rabies), in healthy Gabonese children aged 1-5 years.
To assess the humoral immune response to the vaccine antigens GMZ2, GLURP and MSP3 by measuring the total IgG concentration and IgG isotypes against GMZ2 by ELISA.
To assess B-cell memory by memory B-cell ELISPOT.
To assess the functionality of the immune response by measuring the Growth Inhibition of P. falciparum in the presence or absence of Monocytes, and by measuring the recognition of native antigen of P. falciparum by IFA.
Phase Ib double-blind, randomised, and controlled trial with three groups at one study site; rabies vaccine,30µg and 100 µg GMZ 2 vaccine.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I, Randomized, Controlled, Double-Blind, Single Centre Trial to Evaluate the Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||August 2009|
three doses of 30µg GMZ2,
Biological: GMZ 2 vaccine (GLURP + MSP 3)
three doses of 30µg of GMZ 2 vaccine,
3 doses of 100 µg of GMZ2
Biological: GMZ 2 vaccine (GLURP + MSP 3)
100 µg of GMZ 2 vaccine
Active Comparator: 3
Biological: Rabies vaccine
3 doses of Rabies vaccine
- Immediate reactogenicity. [ Time Frame: within 30 minutes after each injection ]
- Local and systemic reactogenicity [ Time Frame: 14 days following each immunization ]
- unsolicited Adverse events [ Time Frame: up to 1 month after the 3rd vaccination ]
- 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 ]
- Cellular immune response [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703066
|Medical Research Unit, Albert Schweitzer Hospital|
|Study Director:||Peter Kremsner, MD, PhD||Medical research Unit, Albert Schweitzer Hospital|