Status:
UNKNOWN
Phase Ib Trial of MSP3 LSP in Children in Tanzania
Lead Sponsor:
African Malaria Network Trust
Collaborating Sponsors:
London School of Hygiene and Tropical Medicine
Conditions:
Malaria
Eligibility:
All Genders
12-24 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission. Written informed consent will be soug...
Detailed Description
The study is a double blind (observer blind, participant blind), randomized, controlled, dose escalation, Age deescalation, phase Ib study. It will include two parallel groups as follows: * Group 1: ...
Eligibility Criteria
Inclusion
- Children aged 1-2 years old
- Healthy by medical history and physical examination
- Signed /thumb printed informed Consent by guardian/parent
- Resident in the study area village during the whole trial period
Exclusion
- Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the subjects.
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment (for corticosteroids, this means prednisolone or equivalent 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- Cannot be followed for any social, psychological or geographical reasons.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
- Laboratory abnormalities on screened blood samples out of range, more specifically refer to table 4.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception is the receipt of an EPI or licensed vaccine (measles, oral polio, meningococcal and combined diphtheria/pertussis/tetanus vaccines) which may be given 14 days or more before or after vaccination.
- Evidence of chronic or active Hepatitis B infection.
- Presence of chronic illness that, in the judgment of the investigator, would interfere with the study outcomes or pose a threat to the participant's health.
- Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- History of surgical splenectomy.
- Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00469651
Start Date
October 1 2007
End Date
August 1 2008
Last Update
December 14 2007
Active Locations (1)
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1
Kwashemshi village
Korogwe, Tanga, Tanzania