L9LS MAb in Malian Infants

NCT06461026 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2024/158/CE/USTTB
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.

Conditions

Malaria

Outcome Measures

Primary Outcomes (3)

• Incidence of local and systemic AEs occurring within 7 days after the administration of study agent.

  Measured through Day 7

• Severity of local and systemic AEs occurring within 7 days after the administration of study agent.

  Measured through Day 7

• Measurement of study agent in sera of recipients.

  Measured day 7, 28, 84, 140, 196 and 280

Secondary Outcomes (2)

• Total IgG anti-NANP antibody titers measured by ELISA.

  Measured 28 days and 84 days after the third R21/Matrix-MTM vaccination.

• Measurement of Anti-Drug Antibodies (ADA) to L9LS in sera of recipients.

  Measured at day 28, 224 and 280

Study Arms (2)

150 mg of L9LS

EXPERIMENTAL

Participants will receive a dose of 150 mg of L9LS.

Biological: L9LS

Placebo (normal saline)

PLACEBO COMPARATOR

Participants will receive placebo of Normal Saline for comparison.

Other: Normal Saline

Interventions

L9LS BIOLOGICAL

Administered intramuscularly one time.

150 mg of L9LS

Normal Saline OTHER

Administered intramuscularly one time.

Placebo (normal saline)

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥1 to ≤12 months at enrollment.
• Born at ≥37 weeks gestation.
• Parent and/or guardian able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• In good general health and without clinically significant medical history.
• Parent and/or guardian able to provide informed consent.
• Willing to have blood samples and data stored for future research.
• Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study.

You may not qualify if:

• Body weight \<3.5 kg.
• Behavioral, cognitive, or psychiatric disease in the parent and/or guardian that in the opinion of the investigator affects the ability of the parent and/or guardian to understand and comply with the study protocol.
• Any fever (≥ 37.5°C, regardless of route) or acute illness within 7 days prior to randomization.
• Clinically significant congenital anomaly or documented or suspected serious medical illness (e.g., history of epilepsy), serious congenital anomaly, or immediate life-threatening condition in the infant that may interfere with the ability to complete study requirements, as judged by the examining clinician.
• Prior history of a suspected or actual acute life-threatening event.
• Receipt of any blood products, monoclonal or polyclonal antibody/immunoglobulin (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study.
• Any acute or chronic illnesses known in the mother during her pregnancy.
• Parental study comprehension examination score of \<80% correct or per investigator discretion.
• Hemoglobin, WBC, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.)
• ALT or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.)
• Mother and/or infant infected with HIV.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies.
• Receipt of any investigational product within the past 30 days.
• History of a severe allergic reaction or anaphylaxis.
• Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institutes of Health (NIH): collaborator
• University of Washington: collaborator
• Harvard School of Public Health (HSPH): collaborator
• Indiana University School of Medicine, Indiana University: collaborator

Study Sites (3)

Faladje MRTC Clinic

Faladié, Koulikoro, Mali

Location

Kalifabougou MRTC Clinic

Kalifabougou, Koulikoro, Mali

Location

Torodo MRTC Clinic

Torodo, Koulikoro, Mali

Location

MeSH Terms

Conditions

Malaria

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Peter Crompton, MD, MPH

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

• Kassoum Kayentao, MD, MPH, PhD

  Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: August 19, 2024
• Primary Completion: June 27, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared at the time of publication or shortly thereafter.
• Access Criteria: Data from this study may be requested from other researchers indefinitely after the completion of the primary endpoint by contacting Laboratory of Immunogenetics.

Locations

MA (3)