Status:
UNKNOWN
GMZ2-Aluminum Hydroxide Phase I, Tübingen
Lead Sponsor:
European Vaccine Initiative
Conditions:
Malaria
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a randomized, open, dose-selection Phase 1 study. The study aims to evaluate the safety and immunogenicity of 3 doses (10,30 \& 100 micrograms) of the GMZ2 hybrid (GLURP and MSP3) blood stage ...
Detailed Description
The trial is a randomised, open, dose-selection, single centre trial. One adjuvant will be assessed, aluminum hydroxide (alum). Three different dosages - 10µg, 30µg, and 100µg - of GMZ2 will be evalua...
Eligibility Criteria
Inclusion
- Age \> 18 and \< 45 years healthy volunteers (males or females)
- General good health based on history and clinical examination
- All volunteers have to sign the informed consent form
- Negative pregnancy test
- Use of adequate contraception for females up to three months after the third injection (D140)
- Intention to not travel abroad and reachable by phone during the whole study period (15 months).
Exclusion
- History of malaria or residence in malaria endemic areas for the past six months.
- Positive serology for malaria antigen GLURP and/or MSP3.
- Previously participated in a malaria vaccine studies.
- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers
- Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at Tübingen. Positive HIV, HBV or HCV tests
- Volunteers should not be enrolled in any other clinical trial during the whole trial period
- Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immuno-modulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period
- Pregnant or lactating women
- Volunteers unable to give written informed consent
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrollment in the study
- Volunteers should not perform exercise four hours before blood draw and should not donate blood for non study-related purposes during the entire duration of the study
- Known hypersensitivity to any of the vaccine components (adjuvant or peptide)
- Volunteers are not allowed to receive any vaccination or gammaglobulin during a period three months prior to the first immunization and up to six months after the 3rd immunization. If a vaccination is necessary during this period, the volunteer will be withdrawn from the study.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00397449
Start Date
October 1 2006
End Date
December 1 2007
Last Update
August 10 2007
Active Locations (1)
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1
Institut for Tropical Medicine, University of Tubingen
Tübingen, Germany, D-72074 TÜBINGEN