Who is sponsoring NCT05304611?

NCT05304611 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT05304611?

Interventions in NCT05304611: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection, L9LS (VRC-MALMAB0114-00-AB) intravenous injection, Placebo.

What condition does NCT05304611 study?

NCT05304611 studies Plasmodium Falciparum Infection, Malaria.

Is NCT05304611 still recruiting?

NCT05304611 is currently completed. Last updated 10 July 2025.

Are results published for NCT05304611?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-10 · How we verify

NCT05304611: L9LS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Anti-malaria MAb in Malian Children

Completed Phase 2 Results posted Last updated 10 July 2025

What this trial tests

Phase 2 trial testing L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection in Plasmodium Falciparum Infection in 365 participants. Completed in 20 April 2024.

Timeline

18 March 2022

Primary endpoint
20 April 2024

20 April 2024

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	prevention
Enrollment	365
Start date	18 March 2022
Primary completion	20 April 2024
Estimated completion	20 April 2024
Sites	2 locations across Mali

Drugs / interventions tested

L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection — full drug profile →
L9LS (VRC-MALMAB0114-00-AB) intravenous injection — full drug profile →
Placebo

Conditions studied

Plasmodium Falciparum Infection — all drugs for Plasmodium Falciparum Infection →
Malaria — all drugs for Malaria →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 6 to 55, any sex, with Plasmodium Falciparum Infection or Malaria. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Local Adverse Events (AEs) - Year One Primary · Within 7 days after administration of L9LS

Number of participants with local adverse events occurring within 7 days after administration of L9LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion. Adverse events were captured by Investigator examination and history from participants.

Injection site swelling

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	3
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	1
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	1
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	3
Pediatric Efficacy Study: Arm 3: Placebo	0

Pain at Injection site

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	1
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	1

Tenderness at injection site

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Redness at injection site

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Bruising at injection site

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Pruritus at injection site

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	1

Severity of Local Adverse Events (AEs) - Year One Primary · Within 7 days after administration of L9LS

The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any

Grade 1

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	3
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	1
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	2
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	3
Pediatric Efficacy Study: Arm 3: Placebo	2

Grade 2

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Grade 3

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Grade 4

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Grade 5

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Participants With Systemic Adverse Events (AEs) - Year One Primary · Within 7 days after the administration of L9LS

Number of participants with local adverse events occurring within 7 days after administration of L9LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants.

Fever

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	3
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	1

Feeling unusually tired or unwell

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Muscle aches

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Headache

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	1
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	2
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	1
Pediatric Efficacy Study: Arm 3: Placebo	1

Chills

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	1
Pediatric Efficacy Study: Arm 3: Placebo	0

Nausea

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Joint pain

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Severity of Systemic Adverse Events (AEs) - Year One Primary · Within 7 days after the administration of L9LS

The severity of systemic AEs occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity;

Grade 1

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	1
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	1
Pediatric Efficacy Study: Arm 3: Placebo	2

Grade 2

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	1
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	4
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	1
Pediatric Efficacy Study: Arm 3: Placebo	0

Grade 3

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Grade 4

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Grade 5

Group	Value	95% CI
Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	0
Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	0
Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	0
Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	0
Pediatric Dose-escalation Study: Arm 3: Placebo	0
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	0
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	0
Pediatric Efficacy Study: Arm 3: Placebo	0

Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination - Efficacy Study Primary · Day 7 through week 28

Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 14 through week 28 (196 days) after administration of L9LS or placebo. Analysis was done as number of participants who had at least one positive blood smear.

Group	Value	95% CI
Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	36
Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	30
Pediatric Efficacy Study: Arm 3: Placebo	61

Participants With Detectable Anti-drug Antibody (ADA) in Sera - Extension Study Primary · Measured through week 36

Number of participants with detectable anti-drug antibody (ADA) in sera after exposure to L9LS. Serum was collected from participants at specific timepoints throughout the study, on days 0, 7, 28, 84, 168, and 196. The tier 3 assay was used to directly measure ADA's ability to impair L9LS binding to Plasmodium falciparum circumsporozoite protein (PfCSP). Analysis was done to determine number of participants with positive or detectable ADA in sera.

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Maximum Total Plasma Concentration (Cmax) for L9LS - Extension Study Primary · Measured through Week 36

Maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles post dose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	64.63	± 17.36
Pediatric Extension Study: Arm 2: 300 mg of L9LS	116.93	± 24.78

Time to Maximum Plasma Concentration (TMax) for L9LS - Extension Study Primary · Measured through Week 36

Time to maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration.

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	7.00	± 0.16
Pediatric Extension Study: Arm 2: 300 mg of L9LS	7.58	± 3.41

Participants With Local Adverse Events (AEs) - Extension Study Primary · Within 7 days after administration of L9LS

Injection site swelling

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	1
Pediatric Extension Study: Arm 2: 300 mg of L9LS	2
Pediatric Extension Study: Arm 3: Placebo	0

Pain at Injection site

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	1

Tenderness at injection site

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Redness at injection site

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Bruising at injection site

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Pruritus at injection site

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Severity of Local Adverse Events (AEs) - Extension Study Primary · Within 7 days after administration of L9LS

Grade 1

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	1
Pediatric Extension Study: Arm 2: 300 mg of L9LS	2
Pediatric Extension Study: Arm 3: Placebo	1

Grade 2

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Grade 3

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Grade 4

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Grade 5

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Participants With Systemic Adverse Events (AEs) - Extension Study Primary · Within 7 days after the administration of L9LS

Fever

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Feeling unusually tired or unwell

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Muscle aches

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Headache

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	1
Pediatric Extension Study: Arm 2: 300 mg of L9LS	1
Pediatric Extension Study: Arm 3: Placebo	4

Chills

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Nausea

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Joint pain

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Severity of Systemic Adverse Events (AEs) - Extension Study Primary · Within 7 days after the administration of L9LS

Grade 1

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	1

Grade 2

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	1
Pediatric Extension Study: Arm 2: 300 mg of L9LS	1
Pediatric Extension Study: Arm 3: Placebo	3

Grade 3

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Grade 4

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Grade 5

Group	Value	95% CI
Pediatric Extension Study: Arm 1: 150 mg of L9LS	0
Pediatric Extension Study: Arm 2: 300 mg of L9LS	0
Pediatric Extension Study: Arm 3: Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adult Dose-escalation Study: Arm 1: 300 mg of L9LS

Serious: 0/6 (0%)

Deaths: 0/6

Adult Dose-escalation Study: Arm 2: 600 mg of L9LS

Serious: 0/6 (0%)

Deaths: 0/6

Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS

Serious: 0/6 (0%)

Deaths: 0/6

Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Pediatric Dose-escalation Study: Arm 3: Placebo

Serious: 0/18 (0%)

Deaths: 0/18

Pediatric Efficacy Study: Arm 1: 150 mg of L9LS

Serious: 0/75 (0%)

Deaths: 0/75

Pediatric Efficacy Study: Arm 2: 300 mg of L9LS

Serious: 0/75 (0%)

Deaths: 0/75

Pediatric Efficacy Study: Arm 3: Placebo

Serious: 0/75 (0%)

Deaths: 0/75

Pediatric Extension Study: Arm 1: 150 mg of L9LS

Serious: 0/79 (0%)

Deaths: 0/79

Pediatric Extension Study: Arm 2: 300 mg of L9LS

Serious: 0/38 (0%)

Deaths: 0/38

Pediatric Extension Study: Arm 3: Placebo

Serious: 0/118 (0%)

Deaths: 0/118

Other adverse events (56 terms — click to expand)

Reaction	System	Adult Dose-escalation Stud…	Adult Dose-escalation Stud…	Adult Dose-escalation Stud…	Pediatric Dose-escalation …	Pediatric Dose-escalation …	Pediatric Dose-escalation …	Pediatric Efficacy Study: …	Pediatric Efficacy Study: …	Pediatric Efficacy Study: …	Pediatric Extension Study:…	Pediatric Extension Study:…	Pediatric Extension Study:…
Malaria	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rhinitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Tonsillitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Wound	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Blood Pressure Diastolic Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Blood pressure systolic decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Salmonellosis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dermatosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Food poisoning	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Furuncle	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dysentery	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Inflammation	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT05304611 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of L9LS in healthy Malian children, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 7-month malaria season in healthy Malian children 6-10 years of age.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria.
Wu RL, Idris AH, Berkowitz NM, Happe M, et al · · 2022 · cited 91× · PMID 35921449 · DOI 10.1056/nejmoa2203067
Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali.
Kayentao K, Ongoiba A, Preston AC, Healy SA, et al · · 2022 · cited 88× · PMID 36317783 · DOI 10.1056/nejmoa2206966
Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.
Kayentao K, Ongoiba A, Preston AC, Healy SA, et al · · 2024 · cited 66× · PMID 38669354 · DOI 10.1056/nejmoa2312775
Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial.
Lyke KE, Berry AA, Mason K, Idris AH, et al · · 2023 · cited 26× · PMID 36708738 · DOI 10.1016/s1473-3099(22)00793-9
Chemoprevention of malaria with long-acting oral and injectable drugs: an updated target product profile.
El Gaaloul M, Tchouatieu AM, Kayentao K, Campo B, et al · · 2024 · cited 11× · PMID 39425110 · DOI 10.1186/s12936-024-05128-1
Monoclonal antibody applications in travel medicine.
de Jong HK, Grobusch MP. · · 2024 · cited 8× · PMID 38221606 · DOI 10.1186/s40794-023-00212-x
Technological advancements in antibody-based therapeutics for treatment of diseases.
Lu RM, Chiang HL, Yuan JP, Wang HH, et al · · 2025 · cited 6× · PMID 41219972 · DOI 10.1186/s12929-025-01190-2
The Promises and Prospects of Long-Acting Therapeutics for Treatment and Prevention of Infectious Diseases.
Olagunju A, Perazzolo S, Stephen ZR, Ryan M, et al · · 2026 · cited 2× · PMID 40956864 · DOI 10.1146/annurev-pharmtox-071724-100739

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05304611 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 10 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05304611.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05304611: L9LS

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Verify against primary sources