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...

• Status: Completed
• Trial end date: 2017-06-01

Summary

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.

• Phase: Phase 1

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Chloroquine; Chloroquine diphosphate; Pyrimethamine