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NCT03083847 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation PfSPZ-CVac
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT03083847 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 55 participants.
The verdict
NCT03083847, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study 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 * have not been diagnosed with malaria within the past 10 years 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. Part 1 is one month: * Participants will get the parasites by an injection into a vein on day 1 and receive antimalarial medications. * They will have daily visits on days 7-14 * They will take another antimalarial at visits on days 15-17. * The final visit will be on day 29. Part 2 is seven months: * For the first 3 months, participants will get the parasite injection into a vein for 3 injections in total. Each injection will occur once per month while taking an antimalarial drug. * They will have daily visits on days 7-14 after the first injection, and on days 7-11 after the second and third injection. * They will have a final (fourth) injection
Interventions
- DRUG Pyrimethamine
- DRUG Chloroquine Phosphate
- BIOLOGICAL Sanaria PfSPZ Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2019-06-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03083847
The ClinicalTrials.gov registry entry for NCT03083847 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pyrimethamine is the first listed.
NCT03083847 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03083847 about?
NCT03083847 is a clinical study titled "Dose Escalation PfSPZ-CVac". 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 whi...
What is the current status of trial NCT03083847?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2017-06-05. Estimated completion is 2019-06-26.
What interventions are being tested in trial NCT03083847?
The interventions under investigation include: Pyrimethamine (DRUG), Chloroquine Phosphate (DRUG), Sanaria PfSPZ Challenge (BIOLOGICAL).
Who is sponsoring clinical trial NCT03083847?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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