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NCT04206332 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate CIS43LS in Healthy Adults
A Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 2
- Study locations
NCT04206332 is a Phase 1 study of Malaria that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 71 participants, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04206332, a Phase 1 study of Malaria, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection. Researchers want to test if an experimental drug can help. Objective: To test the safety and effectiveness of a drug called CIS43LS that could prevent malaria infection. Eligibility: Healthy people ages 18-50 who have never been infected with malaria Design: Participants were enrolled on the basis of eligibility criteria, evaluated by clinical laboratory tests, self-reported medical history, and physical examination. Participants received CIS43LS either infused into a vein in their arm or injected into the fat under the skin. They were monitored for side effects for up to 4 hours after they received the drug. Participants received a thermometer and recorded their temperature and symptoms every day on/with/via a diary card for 7 days after administration. The administration site was checked for redness, swelling, itching or bruising. Participants had up to 12 follow-up visits. At follow-up visits, participants had blood drawn and were checked for health changes or problems. Most participants who received CIS43LS took part in a Controlled Human Malaria Infection Challenge (CHMI) along with control participants who did not receive CIS43LS. During the CHMI, mosquitoes carrying the malaria parasite bit participants in a controlled setting. The participants had clinic visits every day for up to 12 days starting 7 days after the CHMI. Participants were treated right away with antimalarial medication if they tested positive for malaria. Approximately 21 days after the CHMI, participants were treated with antimalarial medication for 3 days. The study lasted 2-6 months depending on the participant's study group.
Conditions Studied
Interventions
- DRUG VRC-MALMAB0100-00-AB
- OTHER Plasmodium falciparum (P. falciparum) sporozoite challenge
Study Locations (2)
Maryland
- University of Maryland Baltimore, Center for Vaccine Development - Baltimore
- VRC Clinic, NIH Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2020-01-07 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04206332
The ClinicalTrials.gov registry entry for NCT04206332 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (72% lower). 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 1 condition, with Malaria appearing as the primary indexed condition, and to 2 interventions - of which VRC-MALMAB0100-00-AB is the first listed.
NCT04206332 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04206332 about?
NCT04206332 is a clinical study titled "Trial to Evaluate CIS43LS in Healthy Adults". Background: People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection. Researchers want to test if an experimental drug can help. Objective: To test...
What is the current status of trial NCT04206332?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2020-01-07. Estimated completion is 2022-02-28.
What conditions does trial NCT04206332 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT04206332?
The interventions under investigation include: VRC-MALMAB0100-00-AB (DRUG), Plasmodium falciparum (P. falciparum) sporozoite challenge (OTHER).
Who is sponsoring clinical trial NCT04206332?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04206332 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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