MalariaPhase 2NCT07060508
L9LS in Women of Childbearing Potential in Mali
A Phase 2 study testing Single dose of 1800 mg L9LS SC in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in Mali.
Trial summary
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Single dose of 1800 mg L9LS SC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 3 sitesMali
- Study dates
- 22 Jul 2025to 25 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg.
- Males aged ≥18 and ≤49 years (no weight restrictions).
- 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.
- Able to provide informed consent.
- Willing to have blood samples and data stored for future research.
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- Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study.
- Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study Day 0 through the final study visit as described below.
- Reliable methods of birth control include 1 of the following: confirmed pharmacologic contraceptives via parenteral delivery or intrauterine or implantable device.
Who cannot join
- Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female).
- Currently breastfeeding.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol.
- 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.)
- Alanine transaminase (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.)
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- Infected with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)
- Clinically significant abnormal electrocardiogram (ECG; QTc >460 or other significant abnormal findings, including unexplained tachycardia or bradycardia).
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- Receipt of any investigational product within the past 30 days.
- Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit. [Note: Past, current, or planned participation in observational studies is NOT exclusionary; participation in the placebo arm of the Mali adult CIS43LS MAb trial (ClinicalTrials.gov Identifier: NCT04329104) or the placebo arm of the Mali adult L9LS Mab trial (ClinicalTrials.gov Identifier: NCT05816330) is NOT exclusionary.]
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years).
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
- Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors).
- Known immunodeficiency syndrome.
- Known asplenia or functional asplenia.
- Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of day 0.
- Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration.
- Receipt of immunoglobulins and/or blood products within the past 6 months.
- Previous receipt of an investigational malaria vaccine or MAb in the last 5 years.
- Known allergies or contraindication against artemether lumefantrine.
- Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
Trial locations and contacts
3 sites in 1 country.
Mali3 sites
Faladje MRTC Clinic
Faladié, Koulikoro
Kalifabougou MRTC Clinic
Kalifabougou, Koulikoro
Torodo MRTC Clinic
Torodo, Koulikoro
About this study
Official title: Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
Read the detailed description
This is a phase 2 trial evaluating the safety and tolerability of a 1-time subcutaneous (SC) administration of L9LS, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. The primary study hypothesis is that L9LS will be safe and protective against malaria infection. As a secondary objective, the efficacy of L9LS among female participants of childbearing potential within three body weight strata will be compared to placebo. Before study agent administration, all participants will be given artemether-lumefantrine (AL) to clear any preexisting Pf blood stage infection.
This is a randomized, double-blind, placebo-controlled study mainly in WOCBP, weight-stratified (N=270 total), with 2 treatment arms: L9LS 1800 mg SC (n=180) and placebo (n=90) to assess safety and protective efficacy of L9LS. A separate open label male only arm (n=20) will assess sex-differences in the pharmacokinetics (PK) of L9LS at a dose of 1800 mg SC. Male participants will be enrolled during the same time period as the WOCBP arm.
Participants will receive the study agent and be followed at visits on study Days 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examination, blood collection for identification of Pf infection and other research laboratory evaluations.
- Conditions
- Malaria
- Being tested
- Single dose of 1800 mg L9LS SC, Placebo
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of 1800 mg L9LS SCBiological
A human monoclonal antibody to protect against Plasmodium falciparum.
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| L9LS in healthy Malian WOCBP | Experimental | Not described Receives: Biological: Single dose of 1800 mg L9LS SC |
| Placebo in healthy Malian WOCBP | Placebo comparator | Not described Receives: Other: Placebo |
| L9LS in healthy Malian adult males | Experimental | Not described Receives: Biological: Single dose of 1800 mg L9LS SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systemic adverse events (AEs)
Occurring within 7 days after the administration of study agent
Measured: Days 0, 1, 3, and 7.
Severity of local and systemic adverse events (AEs)
Occurring within 7 days after the administration of study agent
Measured: Days 0, 1, 3, and 7.
Incidence of laboratory abnormalities
Occurring within 14 days after the administration of study agent
Measured: Days 7 and 14.
Number of participants with treatment-related laboratory adverse events
Occurring within 14 days after the administration of study agent
Measured: Days 7 and 14.
Pf blood-stage infection as detected by microscopic examination of thick blood smear
Measured: Once every 2 weeks post injection through 24 weeks.
Secondary outcomes (2)
Pf blood-stage infection as detected by thick blood smear and RT-PCR
For 24 weeks after administration of study agent.
Measured: Blood smear once every 2 weeks post injection through 24 weeks.
Concentration of L9LS in sera of recipients.
Measured: Through 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start22 Jul 2025
- Primary completion25 Apr 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), Malaria Research and Training Center, Bamako, Mali, University of the Sciences, Techniques and Technologies of Bamako, Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS), University of Washington, Harvard School of Public Health (HSPH), Indiana University
- Responsible party
- Sponsor
- Investigators
- Peter Crompton, MD, MPH, Principal investigator, National Institutes of Health (NIH)Kassoum Kayentao, MD, MPH, PhD, Principal investigator, Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060508
- Sponsor's protocol ID
- 2025/121/CE/USTTB
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Human data generated in this study for future research will be shared as follows: * De-identified or identified data with approved outside collaborators under appropriate agreements. * De-identified results or data in publication and/or public presentations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
- ClinicalTrials.gov ID
- NCT07060508
- Acronym / sponsor ID
- 2025/121/CE/USTTB
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), Malaria Research and Training Center, Bamako, Mali, University of the Sciences, Techniques and Technologies of Bamako, Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS), University of Washington, Harvard School of Public Health (HSPH), Indiana University
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
Detailed description
This is a phase 2 trial evaluating the safety and tolerability of a 1-time subcutaneous (SC) administration of L9LS, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. The primary study hypothesis is that L9LS will be safe and protective against malaria infection. As a secondary objective, the efficacy of L9LS among female participants of childbearing potential within three body weight strata will be compared to placebo. Before study agent administration, all participants will be given artemether-lumefantrine (AL) to clear any preexisting Pf blood stage infection.
This is a randomized, double-blind, placebo-controlled study mainly in WOCBP, weight-stratified (N=270 total), with 2 treatment arms: L9LS 1800 mg SC (n=180) and placebo (n=90) to assess safety and protective efficacy of L9LS. A separate open label male only arm (n=20) will assess sex-differences in the pharmacokinetics (PK) of L9LS at a dose of 1800 mg SC. Male participants will be enrolled during the same time period as the WOCBP arm.
Participants will receive the study agent and be followed at visits on study Days 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examination, blood collection for identification of Pf infection and other research laboratory evaluations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| L9LS in healthy Malian WOCBP | Experimental | Biological: Single dose of 1800 mg L9LS SC |
| Placebo in healthy Malian WOCBP | Placebo comparator | Other: Placebo |
| L9LS in healthy Malian adult males | Experimental | Biological: Single dose of 1800 mg L9LS SC |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg.
- Males aged ≥18 and ≤49 years (no weight restrictions).
- 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.
- Able to provide informed consent.
Key exclusion criteria (25 listed)
- Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female).
- Currently breastfeeding.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol.
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single dose of 1800 mg L9LS SCA human monoclonal antibody to protect against Plasmodium falciparum. | Biological | L9LS in healthy Malian WOCBP, L9LS in healthy Malian adult males |
| PlaceboNormal saline | Other | Placebo in healthy Malian WOCBP |
Primary outcome
Incidence of local and systemic adverse events (AEs)
Time frame: Days 0, 1, 3, and 7.
Occurring within 7 days after the administration of study agent
Severity of local and systemic adverse events (AEs)
Time frame: Days 0, 1, 3, and 7.
Occurring within 7 days after the administration of study agent
Incidence of laboratory abnormalities
Time frame: Days 7 and 14.
Occurring within 14 days after the administration of study agent
Number of participants with treatment-related laboratory adverse events
Time frame: Days 7 and 14.
Occurring within 14 days after the administration of study agent
Pf blood-stage infection as detected by microscopic examination of thick blood smear
Time frame: Once every 2 weeks post injection through 24 weeks.
2 secondary outcomes
Pf blood-stage infection as detected by thick blood smear and RT-PCR
Time frame: Blood smear once every 2 weeks post injection through 24 weeks.
Concentration of L9LS in sera of recipients.
Time frame: Through 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Human data generated in this study for future research will be shared as follows: * De-identified or identified data with approved outside collaborators under appropriate agreements. * De-identified results or data in publication and/or public presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Crompton, MD, MPH principal investigator
National Institutes of Health (NIH)
Kassoum Kayentao, MD, MPH, PhD principal investigator
Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single dose of 1800 mg L9LS SC in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of local and systemic adverse events (AEs) (time frame: Days 0, 1, 3, and 7.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.