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NCT02511054 · ClinicalTrials.gov registry record · Phase 1
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...
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT02511054: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02511054 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02511054, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study 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 ele
Interventions
- DRUG Chloroquine (CQ)
- DRUG Pyrimethamine (PYR)
- BIOLOGICAL Sanaria PfSPZ Challenge (NF54)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2017-06-01 |
| Phase | Phase 1 |
What the finished NCT02511054 record still lists
NCT02511054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Chloroquine (CQ) is the first listed.
NCT02511054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02511054 about?
NCT02511054 is a clinical study titled "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...". 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. ...
What is the current status of trial NCT02511054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2015-07-21. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT02511054?
The interventions under investigation include: Chloroquine (CQ) (DRUG), Pyrimethamine (PYR) (DRUG), Sanaria PfSPZ Challenge (NF54) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02511054?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02511054's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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