NCT05400655 is a Phase 2 clinical trial of L9LS in Plasmodium Falciparum Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT05400655?

NCT05400655 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT05400655?

Interventions in NCT05400655: L9LS, Placebo.

What condition does NCT05400655 study?

NCT05400655 studies Plasmodium Falciparum Infection, Malaria.

Is NCT05400655 still recruiting?

NCT05400655 is currently completed. Last updated 16 October 2025.

Are results published for NCT05400655?

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

Last reviewed 2025-10-16 · How we verify

NCT05400655

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

Anti-malaria MAb in Kenyan Children

Completed Phase 2 Results posted Last updated 16 October 2025

What this trial tests

Phase 2 trial testing L9LS in Plasmodium Falciparum Infection in 912 participants. Completed in 2 June 2024.

Timeline

14 September 2022

Primary endpoint
2 June 2024

2 June 2024

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	912
Start date	14 September 2022
Primary completion	2 June 2024
Estimated completion	2 June 2024
Sites	1 location across Kenya

Drugs / interventions tested

L9LS — 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 5 Months to 10, 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.

Number of Participants With Local Adverse Events (AEs) Primary · Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)

Number of participants with at least one solicited local adverse events occurring within seven days of administration of intervention. Local reactogenicity included injection site pain, tenderness, bruising, swelling, redness, induration, pruritus, and other (e.g. injection site reaction). Adverse events were captured by Investigator examination and history from participants.

Injection site pain

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	1
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Injection site swelling

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	2
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	2
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	1
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	2
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	3
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	1

Injection site reaction

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Injection site induration

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Injection site pruritus

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Injection site bruising

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Injection site redness

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Number of Participants With Local Adverse Events (AEs) (by Grade) Primary · Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)

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 us

Grade 1

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	2
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	2
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	2
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	4
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Grade 2

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	1
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Grade 3

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	1
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Grade 4

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Grade 5

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Number of Participants With Systemic Adverse Events (AEs) Primary · Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)

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

Chills

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Headache

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	3
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	1
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	1

Pyrexia

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	1
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	3

Malaise

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	1

Muscle aches

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Nausea

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	5

Joint pain

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Number of Participants With Systemic Adverse Events (AEs) (by Grade) Primary · Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)

The severity of systemic adverse events 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

Grade 1

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	3
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	2
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	10

Grade 2

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	3

Grade 3

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	1
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Grade 4

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Grade 5

Group	Value	95% CI
Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo	0
Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS	0
Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo	0
Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Age De-escalation and Dose-escalation study: monitor for all adverse events (related & unrelated) till end of subject participation in study, which may be up to three months from dosing Efficacy study: Related adverse events - till end of subject participation in study, which may be up to 12 months from dosing Unrelated grade 1 or grade 2 adverse events - up to 28 days following dosing. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS

Serious: 0/9 (0%)

Deaths: 0/9

Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo

Serious: 0/6 (0%)

Deaths: 1/6

Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo

Serious: 5/54 (9%)

Deaths: 0/54

Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS

Serious: 4/54 (7%)

Deaths: 0/54

Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo

Serious: 9/54 (17%)

Deaths: 0/54

Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo

Serious: 2/54 (4%)

Deaths: 0/54

Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS

Serious: 0/52 (0%)

Deaths: 0/52

Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo

Serious: 6/56 (11%)

Deaths: 0/56

Serious adverse events (15 terms)

Reaction	System	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Efficacy Study: Arm 1a: Ag…	Efficacy Study: Arm 1b: Ag…	Efficacy Study: Arm 1c: Ag…	Efficacy Study: Arm 2a: Ag…	Efficacy Study: Arm 2b: Ag…	Efficacy Study: Arm 2c: Ag…
Malaria	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hydrocele	Congenital, familial and genetic disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oesophageal Obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis Salmonella	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mumps	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Typhoid Fever	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Burns Second Degree	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
False Positive Investigation Result	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malnutrition	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Epilepsy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (123 terms — click to expand)

Reaction	System	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Age De-escalation and Dose…	Efficacy Study: Arm 1a: Ag…	Efficacy Study: Arm 1b: Ag…	Efficacy Study: Arm 1c: Ag…	Efficacy Study: Arm 2a: Ag…	Efficacy Study: Arm 2b: Ag…	Efficacy Study: Arm 2c: Ag…
Malaria	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash Papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling Hot	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pertussis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tinea Capitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Otitis Media	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Body Tinea	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash Pustular	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Septic Rash	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile Convulsion	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash Vesicular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection Site Swelling	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acarodermatitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Wound Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thermal Burn	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash Pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cerumen Impaction	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ear Pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bacterial Infection	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Furuncle	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatitis A	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mumps	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Wound Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Malaria, Hydrocele, Oesophageal Obstruction, Pyrexia, Bronchiolitis, Febrile Infection, Gastroenteritis, Gastroenteritis Salmonella.

Data from ClinicalTrials.gov NCT05400655 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission.

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
Anti-sporozoite monoclonal antibody for malaria prevention: secondary efficacy outcome of a phase 2 randomized trial.
Skinner J, Kayentao K, Ongoiba A, Healy SA, et al · · 2025 · cited 7× · PMID 40461818 · DOI 10.1038/s41591-025-03739-y
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Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05400655 (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: 16 October 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/NCT05400655.

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NCT05400655

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Results — posted to ClinicalTrials.gov

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

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