Clinical Trial: Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: VRC 314: A Phase 1, Open-Label, Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Durability of Protection Following Intravenous and Intramuscular Admi

Brief Summary:

Background:

- People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease if later exposed to normal malaria parasites. Scientists have discovered how to make the weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if people who receive the vaccine get malaria after being bitten in a controlled setting (a controlled human malaria infection, CHMI).

Objective:

- To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting.

Eligibility:

- Healthy adults 18 45 years old.

Design:

  • Participants will be screened with medical history, physical exam, blood and lab tests, and EKG.
  • Participants will be split into 8 groups, to be in the study for 3 12 months.
  • Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or muscle.
  • Participants will keep a health diary and be contacted by phone.
  • For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5 minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be exposed to malaria more than once.
  • After CHMI, participants will visit the clinic very frequently (including daily visits for 12 days) for 28 days.
  • Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical history may also be repeated