Status:
COMPLETED
Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers
Lead Sponsor:
Malaria Vaccine and Drug Development Center
Collaborating Sponsors:
Fundacion Clinica Valle del Lili
Conditions:
MALARIA
FEVER
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The study is a randomized open label clinical trial to verify the reproducibility of a sporozoite challenge model for Plasmodium vivax in humans. The verification of the reproducibility of such a mode...
Detailed Description
Study design A randomized, open-label clinical trial was designed to standardize a P. vivax sporozoite challenge model in malaria-naïve volunteers, specifically, the relationship between the number o...
Eligibility Criteria
Inclusion
- Healthy, adult male or non-pregnant females (18-45 years of age).
- Capacity to sign a free informed consent form of participation along with two witnesses.
- Use of adequate contraceptive method from the initiation of the study until three months after sporozoite challenge.
- No plans to travel to malaria endemic areas during the course of the study (a year).
- No plans to travel outside the study area from the 7th day until 31st day after the challenge.
- Reachable by phone during the whole study period.
- Able to participate during the whole study period.
Exclusion
- Are less than 18 and over 45 years of age.
- Are female who is pregnant at serum positive B-HCG screening, planning to become pregnant or who is nursing.
- Have a Duffy negative phenotype.
- Have a G-6-PD deficiency or any other hemoglobinopathy.
- Current or past infection with any species of malaria as demonstrated by a positive TBS on screening or history of a documented positive blood smear. P. vivax IFAT of 1
- Have a known history of allergy to antimalarial drugs or immediate type hypersensitivity reactions to mosquito bites.
- Clinical or laboratory evidence of significant systemic disease, including hepatic, renal, cardiac, immunologic or hematological disease, HIV positive or have any other known immunodeficiency (including receiving immunosuppressive therapy or a history of splenectomy); infected with hepatitis B or C virus; have a history of autoimmune disease (including inflammatory bowel disease, hemolytic anemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.) or connective tissue disease or have any other serious underlying medical condition.
- Clinically significant laboratory abnormalities as determined by the Investigator(s).
- Plan to have surgery between enrollment and the end of the challenge follow-up.
- Previous history of alcoholism or drugs use which interfere with social activities of the volunteer
- Have any other conditions that are determined by at least two concurring investigators that may interfere with the capacity to provide free and willing informed consent.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00367380
Start Date
December 1 2006
End Date
March 1 2007
Last Update
March 22 2021
Active Locations (1)
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1
Malaria Vaccine and Drug Development Center
Cali, Valle del Cauca Department, Colombia, 25574