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Trial to Evaluate L9LS in Healthy Adults

NCT05019729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-08-14

Study results available
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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.

Conditions

Interventions

DRUG

VRC-MALMAB0114-00-AB

VRC-MALMAB0114-00-AB (L9LS) is a monoclonal antibody that binds an epitope of the Plasmodium falciparum circumsporozoite protein.

OTHER

Plasmodium falciparum (P. falciparum) sporozoite challenge

Participants were exposed to bites on the forearm from mosquitoes infected with Plasmodium falciparum

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Richard L Wu, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2022-09-19
Completion
2022-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05019729 on ClinicalTrials.gov