Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Trial to Determine Safety and Protective Efficacy of Sanaria PfSPZ Challenge With Concurrent Pyrimethamine Treatment That Inhibits Development of Asexual B...

Completed · Phase 1

Conditions studied: Malaria

In brief

Background: \- Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Although malaria does not occur in the United States, many people in Africa, Asia, and South America do get malaria. In some cases, malaria can cause death. In 2013 alone, 584,000 people died due to malaria. Researchers want to find ways to prevent and treat malaria. Objective: \- To find out if combining live, infectious malaria parasites (known as Sanaria PfSPZ Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine \[PYR\] and chloroquine \[CQ\]) is safe and can provide people protection against malaria. The Sanaria PfSPZ Challenge has been used in other studies without significant side effects. Eligibility: * Healthy people ages 18-50 who weigh less than 170 pounds and are not pregnant or breastfeeding * No history of hepatitis B, hepatitis C, or HIV infection * Not currently enrolled in a clinical trial that involves a research drug or vaccine * Have not traveled to an area with high malaria transmission within the last 5 years * Never diagnosed with malaria in the past Design: * Participants will be in 1 of 4 groups. * Participants will receive a combination of injections and drugs. What combination they will receive will depend on what group they are in. This combination of injections and drugs may include: * Injections of Sanaria PfSPZ Challenge (live, infectious malaria parasites) into a vein * FDA approved antimalarial drug called chloroquine (CQ) * FDA approved antimalarial drug called pyrimethamine (PYR) * FDA approved antimalarial drug called Malarone * The study will last approximately 3-7 months (depending on which group participants are in). * There will be up to 68 study visits for three groups. One group will have up to 27 study visits. During the study visits, participants may have: * Medical history review * Physical exams * Electrocardiogram (ECG): soft electrodes will be placed on the skin. A machine will record the heart s electrical signals to evaluate heart function. * Blood and urine tests * Medication given in the clinic under direct observation * Injection of Sanaria PfSPZ Challenge into a vein * Participants will receive a diary, thermometer, and ruler to record their body temperature and any symptoms.

Key facts

Study ID

NCT02511054

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

57

Starts

2015-07-21

Expected to finish

2017-06-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
• Currently is breast-feeding (if female).
• Pregnancy as determined by a positive urine or serum human choriogonadotropin (beta-hCG) test at any point during the study (if female).
• Recent travel to a malaria endemic area within 5 years of enrollment
• Planned travel to a malaria endemic area during the study period
• History of confirmed malaria diagnosis on peripheral blood smear or by clinical history in the past 10 years.
• Hemoglobin, WBC, platelets, ALT, and creatinine outside of local lab normal range (subjects may be included at the investigator s discretion for not clinically significant values outside of normal range)
• Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin. Subject can be included if investigator determine the abnormality is not clinically significant .
• Anticipated use during the study period, or use within the following periods prior to enrollment:
• Investigational malaria vaccine within the last five years
• Malaria chemoprophylaxis within 6 months
• Chronic systemic immunosuppressive medications (>14 days) within 6 months (e.g.cytotoxic medications, oral/parental corticosteroids >0.5 mg/kg/day prednisone or equivalent). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are allowed.
• Blood products or immunoglobulins within 6 months
• Systemic antibiotics with antimalarial effects within 30 days (such as clindamycin, doxycycline)
• Investigational or non-registered product or vaccine within 30 days
• Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to Sanaria PfSPZ Challenge
• Medications known to interact with pyrimethamine, chloroquine, atovaquone, proguanil (during the study period only)
• History of:
• Sickle cell disease, sickle cell trait, or other hemoglobinopathies
• Splenectomy or functional asplenia
• Systemic anaphylaxis
• Any allergic reactions to study drugs
• Documented history of chronic or active neurologic disease (including seizures, uncontrolled migraine headaches)
• Psoriasis or porphyria
• Ocular diseases including retinopathy or visual field defects

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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