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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

Able and willing to complete the informed consent process

Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 after l9ls product administration through the study participation, up to week 24

Awards & highlights

VRC 614 Trial Summary

This trial is testing a drug to prevent malaria infection. Healthy adults ages 18-50 who have never had malaria can participate. The trial will last 2-6 months.

VRC 614 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

VRC 614 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 after l9ls product administration through the study participation, up to week 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

Blood Creatinine Increased

20%

Malaise

20%

Lymphadenopathy

20%

Administration site bruise

20%

Constipation

20%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Group 1: L9LS (1 mg/kg IV)

Group 5: CHMI Controls

Group 2: L9LS (5 mg/kg IV)

Group 3: L9LS (5 mg/kg SC)

Group 4: L9LS (20 mg/kg IV)

Group 6: L9LS (5 mg/kg IM)

VRC 614 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

0 / 10Eligibility criteria met

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

3,268 Previous Clinical Trials

5,481,100 Total Patients Enrolled

149 Trials studying Malaria

612,624 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for participation in this experiment limited to those under 30?

"According to the study's inclusion criteria, invited patients must be between 18 and 50 years of age. For younger individuals (under 18), there are 68 clinical trials that may meet their needs; 34 such studies exist for those over 65."

Answered by AI

Is participation in this experiment open to the public?

"For entry into this trial, potential participants must have malaria and be between the ages of 18 to 50. Up to 32 members may partake in the study."

Answered by AI

Is the medication VRC-MALMAB0114-00-AB safe to administer to patients?

"Due to the experimental nature of VRC-MALMAB0114-00-AB, our team assesses its safety at a 1. This is because it has only been through one phase of testing and there is limited evidence supporting efficacy or safety."

Answered by AI

Is this medical trial currently accepting new participants?

"Clinicaltrials.gov indicates that this medical trial, initially uploaded on September 13th 2021 and revised October 13th 2022, is no longer seeking participants at the present moment. However, there are 99 other trials actively recruiting patients."

Answered by AI

Recent research and studies

The LancetJournal

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Therapeutic Monoclonal Antibody Mab114 Targeting Ebola Virus Glycoprotein (VRC 608): An Open-label Phase 1 Study

Gaudinski, Martin R, Emily E Coates, Laura Novik, Alicia Widge, Katherine V Houser, Eugeania Burch, LaSonji A Holman, et al.. 2019. “Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Therapeutic Monoclonal Antibody Mab114 Targeting Ebola Virus Glycoprotein (VRC 608): An Open-label Phase 1 Study”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(19)30036-4.

ScienceJournal

Protection Against Malaria by Intravenous Immunization with a Nonreplicating Sporozoite Vaccine

Seder, Robert A., Lee-Jah Chang, Mary E. Enama, Kathryn L. Zephir, Uzma N. Sarwar, Ingelise J. Gordon, LaSonji A. Holman, et al.. 2013. “Protection Against Malaria by Intravenous Immunization with a Nonreplicating Sporozoite Vaccine”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1241800.

Nature MedicineJournal

Protection Against Malaria at 1 Year and Immune Correlates Following Pfspz Vaccination

Ishizuka, Andrew S, Kirsten E Lyke, Adam DeZure, Andrea A Berry, Thomas L Richie, Floreliz H Mendoza, Mary E Enama, et al.. 2016. “Protection Against Malaria at 1 Year and Immune Correlates Following Pfspz Vaccination”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm.4110.

New England Journal of MedicineJournal