Clinical Trial for the Development of a Safe Malaria Challenge Model That Can be Reproduced in Humans

Completed · Phase 1

Conditions studied: Plasmodium Vivax Malaria

In brief

The purpose of this study is to demonstrate that volunteers can be safely and reproducibly infected with Plasmodium vivax (P. vivax) by the bites of experimentally infected Anopheles dirus (An. dirus) mosquitoes carrying P. vivax sporozoites in their salivary glands.

Key facts

Study ID

NCT00935623

Run by

U.S. Army Medical Research and Development Command

People needed

12

Starts

2009-04-21

Expected to finish

2011-09-01

Last updated by the study team

2018-08-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults (male or non-pregnant, non-lactating female) 18 to 55 years of age;
• Able to provide free and willing written informed consent to participate;
• A score at least 80% correct on a 10 question Assessment of Understanding;
• No plans to travel to a malaria endemic area during the course of the study;
• Duffy positive phenotype;
• Normal (non-deficient) G6PD phenotype (range : 4.6 to 13.5 u/gm hemoglobin);
• Free of significant health problems as established by medical history and clinical examination completed prior to the study;
• Available to participate and reachable by phone for duration of study (approximately 9 months starting from screening).
• Only subjects with no or low cardiac risk factors according to the Gaziano study and a normal EKG will be included in the study

You may not qualify if…

• Pregnant or nursing at screening or plans to become pregnant or nurse from the time of enrollment until 6 months after sporozoite challenge;
• Duffy negative phenotype;
• G6PD deficiency or have any hemoglobinopathy by history;
• Past infection with any species of malaria (as demonstrated by a positive thick smear) in the last 5 years;
• History of receipt of treatment or prophylaxis for malaria during the previous 6 months;
• History of receipt of malaria vaccine within the previous 5 years;
• History of receipt of malaria challenge (being bitten by experimentally infected mosquitoes) within the previous 5 years;
• Plans to travel to malarious areas during the study period;
• Allergy to antimalarials or significant (e.g. systemic) hypersensitivity reactions to mosquito bites (local hypersensitivity reactions at the site of a mosquito bite are not an exclusion criterion);
• History of psoriasis (given its interaction with chloroquine);
• Use of any investigational or non-registered drug or vaccine within 30 days preceding the challenge or planned use during the study period;
• Use or planned use of any drugs with significant anti-malarial activity, such as doxycycline, clindamycin, azithromycin, during the study period (volunteers can withhold the use of these medications during the study period, at the minimum starting from 4 weeks before the challenge until 4 weeks after becoming parasitemic);
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection and history of splenectomy;
• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of challenge;
• For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day;
• Inhaled and topical steroids are allowed;
• A family history of congenital or hereditary immunodeficiency;
• Chronic or active neurologic disease including seizure disorder;
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or abnormal baseline laboratory screening tests:
• ALT above normal range (table 9);
• Creatinine above normal range (table 9);
• Hemoglobin below normal range (table 10);
• Platelet count below normal range (table 10);
• Total white cell count below normal range (table 10);
• Acute disease at the time of enrollment

Where it is running

• WRAIR Clinical Trials Center — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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