Status:
UNKNOWN
Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years
Lead Sponsor:
African Malaria Network Trust
Conditions:
Malaria
Eligibility:
All Genders
1-5 years
Phase:
PHASE1
Brief Summary
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 allocat...
Detailed 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 State Serum Institute/EMVI in Denmark and ...
Eligibility Criteria
Inclusion
- Children age 1-5 years inclusive at the time of screening;
- Residing in Lambaréné for the duration of the study;
- Written informed consent obtained before screening and study start, respectively;
- Available to participate in follow-up for the duration of study (13 months);
- General good health based on history and clinical examination.
Exclusion
- Previous vaccination with any other malaria candidate vaccine.
- Concomitant vaccination with a investigational vaccine or a rabies vaccine;
- Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study vaccination, or planned use up to 30 days after the third vaccination;
- Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccination. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids;
- Confirmed or suspected immunosuppressive or immuno-deficient condition, including human immunodeficiency virus (HIV) infection;
- Confirmed or suspected autoimmune disease;
- History of allergic reactions or anaphylaxis to immunizations or to any of the vaccine components, or of serious allergic reactions to any substance, requiring hospitalization or emergent medical care;
- History of splenectomy;
- Laboratory evidence of liver disease (Alanine aminotransferase \[ALT\] greater than 1.25 times the upper limit of normal (\<45 U/L) of the testing laboratory);
- Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing);
- Laboratory evidence of haematological disease (absolute leukocyte count 3.5-11/µL, absolute lymphocyte count 560-5280/µL, platelet count 120,000-400,000/µL, or haemoglobin 10.0-16.5g/dL);
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or planned administration during the study period;
- Simultaneous participation in any other interventional clinical trial;
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, malnutrition, or any other clinical findings that in the opinion of the clinical investigator, may increase the risk of participating in the study;
- Other condition that in the opinion of the clinical investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00703066
Start Date
June 1 2008
End Date
August 1 2009
Last Update
November 25 2008
Active Locations (1)
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1
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné, Gabon