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...
Public ClinicalTrials.gov record NCT02511054. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 Blood Stages of Plasmodium Falciparumc
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02511054
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Interventions
- Chloroquine (CQ) Drug
- Pyrimethamine (PYR) Drug
- Sanaria PfSPZ Challenge (NF54) Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 20, 2015
- Primary completion
- Oct 20, 2016
- Completion
- May 31, 2017
- Last update posted
- Jul 1, 2017
2015 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02511054, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02511054 live on ClinicalTrials.gov.