Status:
COMPLETED
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
Lead Sponsor:
Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
Collaborating Sponsors:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Second Military Medical University
Conditions:
Prophylaxis Against Plasmodium Falciparum Malaria
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and immunogenicity of 3...
Detailed Description
This is a double blind, randomized, controlled Phase I study of PfCp2.9, an experimental malaria vaccine candidate, adjuvanted with Montanide ISA 720. The primary objective of this study is to assess...
Eligibility Criteria
Inclusion
- Healthy male or female ≥ 18 and ≤ 45 years of age
- Agrees not to donate blood during the course of the trial.
- Signed written informed consent provided.
- Available to participate for the study duration.
Exclusion
- History of allergic reactions following any vaccination.
- Involvement in drug or other vaccine trial within four weeks prior to the trial.
- Acute illness within four weeks prior to the trial.
- Presence of fever at the time of vaccination, i.e. body temperature (by axillary) \> 37.5 C.
- Presence of any chronic illness/disease including diabetes mellitus, tuberculosis, leprosy, epilepsy and hypertension determined by medical history or examination.
- Persons on systemic corticosteroids, immunomodulators or anticoagulants within four weeks prior to vaccination.
- Persons with a history of allergic manifestations requiring treatment with injectable antihistamines, adrenaline or steroids.
- Pregnancy. Women should not be pregnant, lactating, or planning pregnancy throughout the study period. A urinary pregnancy test (immuno-chromatography) will be performed for all women of child-bearing potential at entry and prior to each vaccination. Adequate contraception throughout the study should be used if applicable.
- Sexually active woman not using contraceptives.
- Current smoker ( ≥ 20 cigarettes/day).
- History of malaria: persons with a known history of malaria or with positive markers for antibodies to malaria parasite by IFA and/or ELISA.
- History of residing in a malaria endemic region or malaria exposure (travel) within last two years.
- Abnormal hematology and clinical chemistry considered to be clinically significant.
- Abnormal urine routine test considered to be clinically significant
- Persons with positive markers for HBV (HBsAg) and/or HCV (Anti-HCV) infection.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00284973
Start Date
January 1 2006
Last Update
April 14 2015
Active Locations (1)
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1
Shanghai Changhai Hospital
Shanghai, China