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NCT05019729 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate L9LS in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05019729: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05019729 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05019729, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly. Researchers want to test a drug to prevent malaria. Objective: To test if the drug L9LS is safe and if it prevents malaria infection in people. Eligibility: Healthy adults ages 18-50 who have never had malaria. Design: Participants were screened with a medical history, physical exam, and blood tests. Participants were divided into 6 groups: * Three groups received L9LS by infusion into a vein, and gave blood samples before and after infusion. * One group received L9LS injected into the fat under the skin. * One group did not get L9LS. * One group received L9LS injected into the muscle. All participants who received L9LS were monitored for side effects. They had 2-3 follow-up visits during the week after the drug was given, and gave blood samples. They received a thermometer to check their temperature daily for 7 days. They received a tool to measure any redness, swelling, or bruising at the injection site. Most participants took part in the controlled human malaria infection (CHMI) or malaria challenge to find out if L9LS prevents malaria after being bitten by infected mosquitos. Participants in the group who received L9LS injected in the muscle were enrolled after CHMI and did not take part in the CHMI. Participants who received CHMI were bitten by mosquitoes carrying the malaria parasites. A cup containing mosquitoes was placed on their arm for 5 minutes. On days 7-17 after exposure, they received daily study visits to give blood samples. Those who got malaria were treated immediately. On day 21, all CHMI participants received treatment for malaria. Participation lasted 2-6 months, depending on study group.
Primary Outcome
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogen
Interventions
- OTHER Plasmodium falciparum (P. falciparum) sporozoite challenge
- DRUG VRC-MALMAB0114-00-AB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-09-13 |
| Est. Completion | 2022-09-19 |
| Phase | Phase 1 |
What the finished NCT05019729 record still lists
NCT05019729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Plasmodium falciparum (P. falciparum) sporozoite challenge is the first listed.
NCT05019729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05019729 about?
NCT05019729 is a clinical study titled "Trial to Evaluate L9LS in Healthy Adults". Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly. Researchers want to test a drug to prevent malaria. Objective: To test if the drug L9LS is safe and if ...
What is the current status of trial NCT05019729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2021-09-13. Estimated completion is 2022-09-19.
What interventions are being tested in trial NCT05019729?
The interventions under investigation include: Plasmodium falciparum (P. falciparum) sporozoite challenge (OTHER), VRC-MALMAB0114-00-AB (DRUG).
Who is sponsoring clinical trial NCT05019729?
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 NCT05019729's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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