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Monoclonal Antibodies

VRC-MALMAB0114-00-AB for Malaria (VRC 614 Trial)

Phase 1
Waitlist Available
Led By Richard L Wu, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 after l9ls product administration through the study participation, up to week 24
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if L9LS, a special medicine, can prevent malaria in healthy adults aged 18-50 who have never had the disease. L9LS works by using custom-made proteins to stop the malaria parasite after a mosquito bite. L9LS is a new type of antimalarial treatment that has shown high protective efficacy in earlier tests.

Eligible Conditions
  • Malaria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 after l9ls product administration through the study participation, up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 after l9ls product administration through the study participation, up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of L9LS Product Administration
Number of Participants With Abnormal Laboratory Measures of Safety Following L9LS Product Administration
+4 more
Secondary study objectives
Number of Participants Who Developed Plasmodium Falciparum (P. Falciparum) Parasitemia Following Controlled Human Malaria Infection (CHMI) Challenge
Pharmacokinetic (PK) Parameters of L9LS: Beta Half-life (T1/2b)
Pharmacokinetic (PK) Parameters of L9LS: Clearance (CL) Following IV Administration
+5 more

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05019729
60%
Administration site pain
20%
Administration site bruise
20%
Malaise
20%
Headache
20%
Blood Creatinine Increased
20%
Constipation
20%
Lymphadenopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: L9LS (1 mg/kg IV)
Group 2: L9LS (5 mg/kg IV)
Group 3: L9LS (5 mg/kg SC)
Group 4: L9LS (20 mg/kg IV)
Group 5: CHMI Controls
Group 6: L9LS (5 mg/kg IM)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group 6: L9LS (5 mg/kg IM)Experimental Treatment1 Intervention
L9LS (5 mg/kg) administered by intramuscular (IM) injection (Day 0)
Group II: Group 5: CHMI ControlsExperimental Treatment1 Intervention
Control participants who did not receive L9LS and were enrolled to complete the controlled human malaria infection (CHMI)
Group III: Group 4: L9LS (20 mg/kg IV)Experimental Treatment2 Interventions
L9LS (20 mg/kg) administered by IV infusion (Day 0)
Group IV: Group 3: L9LS (5 mg/kg SC)Experimental Treatment2 Interventions
L9LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
Group V: Group 2: L9LS (5 mg/kg IV)Experimental Treatment2 Interventions
L9LS (5 mg/kg) administered by IV infusion (Day 0)
Group VI: Group 1: L9LS (1 mg/kg IV)Experimental Treatment2 Interventions
L9LS (1 mg/kg) administered by intravenous (IV) infusion (Day 0)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VRC-MALMAB0114-00-AB
2021
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,320 Previous Clinical Trials
5,364,613 Total Patients Enrolled
153 Trials studying Malaria
439,038 Patients Enrolled for Malaria
Richard L Wu, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
118 Total Patients Enrolled
~8 spots leftby Nov 2025
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