Clinical Trial: Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Trial to Determine Safety and Development of Protective Efficacy After Exposure to Only Pre-erythrocytic Stages of Plasmodium Falciparum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Dose Escalation Trial to Determine Safety and Development of Protective Efficacy After Exposure to Only Pre-e

Brief Summary:

Background:

People get malaria from bites from infected mosquitos. Researchers are studying a vaccine strategy. They will give people malaria parasites by injecting them with live infectious malaria parasites with antimalarial medications and then see if this strategy prevents malaria infection while off antimalarial medications.

Objective:

To see if combining a high dose of live, infectious malaria parasites (known as Sanaria PfSPZ Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] OR chloroquine [CQ]) is safe and can provide people protection against malaria.

Eligibility:

Healthy adults ages 18-50 who:

  • are not pregnant or breastfeeding or planning on becoming pregnant while in the study
  • are not infected with HIV, Hepatitis B or Hepatitis C
  • have reliable early morning access to the NIH Clinical Center
  • are able to come to the outpatient clinic frequently, sometimes daily

Design:

  • Participants will be screened with medical history and physical exam. They will have heart, blood, and urine tests.
  • Participants will have blood drawn for tests at most visits.
  • Participants will keep track of their temperature and symptoms during some sections of the study.
  • Participants will join one part of the study.