Plasmodium Falciparum InfectionPhase 2NCT05816330
L9LS MAb in Malian Adults
A Phase 2 study testing L9LS (VRC-MALMAB0114-00-AB) in people with Plasmodium Falciparum Infection and Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in Mali.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Infection, Malaria
- What is being tested?
- L9LS (VRC-MALMAB0114-00-AB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 3 sitesMali
- Study dates
- 25 May 2023to 11 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 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 ≤55 years and weighing ≥ 50.0 and ≤ 100.0 kg.
- 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.
- Nonchildbearing women will be required to report date of last menstrual period, history of surgical sterility (i.e., tubal ligation, hysterectomy) or premature ovarian insufficiency, and will have urine or serum pregnancy tests performed per protocol.
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 subject to understand and comply with the study protocol.
- Study comprehension examination score of <80% correct or per investigator discretion.
- Hemoglobin, white blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Subjects 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. (Subjects may be included at the investigator's discretion for "not clinically significant" values.)
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- Infected with human immunodeficiency virus (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) 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 monoclonal antibody 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 subject participating in the trial, interfere with the evaluation of the study objectives, or render the subject unable to comply with the protocol.
Trial locations and contacts
3 sites in 1 country.
Mali3 sites
Faladje MRTC Clinic
Faladiè, 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 Adults in Mali
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.
Read the detailed description
A phase 2 trial evaluating the safety and tolerability of a one time subcutaneous (SC) administration of L9LS, as well its protective efficacy against naturally occurring Pf infection over a 6-month malaria season. The primary study hypotheses is that L9LS will be safe and protective against malaria infection. As a secondary objective, the efficacy of L9LS within three body weight strata among female participants will each be compared to placebo. Before study agent administration, all subjects will be given artemether lumefantrine to clear any preexisting Pf blood stage infection.
The study is a randomized, double-blind, placebo-controlled, sex-stratified (2:1 female to male ratio) and weight-stratified trial (N=288 total) with 2 treatment arms: L9LS 900 mg SC (n=216) and placebo (n=72) to assess safety and protective efficacy of L9LS compared to placebo.
Subjects will receive the study agent and be followed at study visits 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examination and blood collection for identification of Pf infection and other research laboratory evaluations.
- Conditions
- Plasmodium Falciparum Infection, Malaria
- Being tested
- L9LS (VRC-MALMAB0114-00-AB), Placebo
- Keywords
- Malaria, Plasmodium falciparum, L9LS, Monoclonal antibodies
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L9LS (VRC-MALMAB0114-00-AB)Biological
Administered one time via subcutaneous route.
PlaceboOther
Normal saline administered one time via subcutaneous route.
| Study group | Role | What they receive |
|---|---|---|
| L9LS 900 mg | Experimental | Adult participants receive a single dose of L9LS 900 mg subcutaneously. Receives: Biological: L9LS (VRC-MALMAB0114-00-AB) |
| Placebo | Placebo comparator | Adult participants receive a single dose of Placebo subcutaneously. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local Adverse Events (AEs)
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.
Measured: Within 7 days after administration of intervention
Number of Participants With Systemic Adverse Events (AEs)
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.
Measured: Within 7 days after administration of intervention
Number of Participants With Local Adverse Events (AEs) (by Grade)
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 use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = > 10 cm; Induration/Swelling = > 10 cm or prevents daily activity.
Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death
Measured: Within 7 days after administration of intervention
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
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 activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration
Grade 4: Fever = > 39.5^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock
Grade 5: Death
Measured: Within 7 days after administration of intervention
Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination for Thick Blood Smear
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 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood smear.
Measured: Day 7 through week 24
Secondary outcomes (4)
Participants With Plasmodium Falciparum (Pf) Infection Detected by Real-Time Polymerase Chain Reaction (RT-PCR)
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood sample positive for Pf was assessed by real-time polymerase chain reaction (RT-PCR) of blood sample collected from participants from day 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood sample.
Measured: Day 7 through week 24
Maximum Total Plasma Concentration (Cmax) for L9LS
Maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, \& 168 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles postdose. 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.
Measured: Measure through week 24
Time to Maximum Plasma Concentration (TMax) for L9LS - Hours
Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS on day 7 post administration of drug. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in hours) 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.
Measured: Day 7 post administration of drug
Time to Maximum Plasma Concentration (TMax) for L9LS - Days
Time to maximum total plasma concentration (Cmax) following a 900 mg dose of L9LS. Serum collected on days 0, 1, 7, 14, 28, 56, 84, 112, 140, \& 168 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.
Measured: Measure through week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start25 May 2023
- Primary completion11 Feb 2024
- Study completion11 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plasmodium Falciparum InfectionStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 490 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, University of Washington, Harvard School of Public Health (HSPH), Indiana University
- Responsible party
- Sponsor
- Investigators
- Kassoum Kayentao, MD, MPH, PhD, Principal investigator, Faculté de Médecine Pharmacie d'Odontostomatologie (FMPOS)Peter Crompton, MD, MPH, Principal investigator, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816330
- Sponsor's protocol ID
- 2023/109/CE/USTTB
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2023
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Apr 2025. 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 Adults in Mali
- ClinicalTrials.gov ID
- NCT05816330
- Acronym / sponsor ID
- 2023/109/CE/USTTB
- Conditions
- Plasmodium Falciparum Infection, Malaria
- Keywords
- Malaria, Plasmodium falciparum, L9LS, Monoclonal antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 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, University of Washington, Harvard School of Public Health (HSPH), Indiana University
- Study start
- 25 May 2023 (actual)
- Primary completion
- 11 Feb 2024 (actual)
- Study completion
- 11 Feb 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.
Detailed description
A phase 2 trial evaluating the safety and tolerability of a one time subcutaneous (SC) administration of L9LS, as well its protective efficacy against naturally occurring Pf infection over a 6-month malaria season. The primary study hypotheses is that L9LS will be safe and protective against malaria infection. As a secondary objective, the efficacy of L9LS within three body weight strata among female participants will each be compared to placebo. Before study agent administration, all subjects will be given artemether lumefantrine to clear any preexisting Pf blood stage infection.
The study is a randomized, double-blind, placebo-controlled, sex-stratified (2:1 female to male ratio) and weight-stratified trial (N=288 total) with 2 treatment arms: L9LS 900 mg SC (n=216) and placebo (n=72) to assess safety and protective efficacy of L9LS compared to placebo.
Subjects will receive the study agent and be followed at study visits 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examination and blood collection for identification of Pf infection and other research laboratory evaluations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L9LS 900 mg | Experimental | Biological: L9LS (VRC-MALMAB0114-00-AB)Adult participants receive a single dose of L9LS 900 mg subcutaneously. |
| Placebo | Placebo comparator | Other: PlaceboAdult participants receive a single dose of Placebo subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg.
- Males aged ≥18 and ≤55 years and weighing ≥ 50.0 and ≤ 100.0 kg.
- 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 subject to understand and comply with the study protocol.
- Study comprehension examination score of <80% correct or per investigator discretion.
- Hemoglobin, white blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Subjects 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 |
|---|---|---|
| L9LS (VRC-MALMAB0114-00-AB)Administered one time via subcutaneous route. | Biological | L9LS 900 mg |
| PlaceboNormal saline administered one time via subcutaneous route. | Other | Placebo |
Primary outcome
Number of Participants With Local Adverse Events (AEs)
Time frame: Within 7 days after administration of intervention
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.
Number of Participants With Systemic Adverse Events (AEs)
Time frame: Within 7 days after administration of intervention
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.
Number of Participants With Local Adverse Events (AEs) (by Grade)
Time frame: Within 7 days after administration of 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 use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = > 10 cm; Induration/Swelling = > 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
Time frame: Within 7 days after administration of 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 activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = > 39.5^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death
Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination for Thick Blood Smear
Time frame: Day 7 through week 24
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 7 through week 24 (168 days) after administration of L9LS or placebo. Sample was collected every two weeks from day seven until week 24. Analysis was done as number of participants who had at least one positive blood smear.
4 secondary outcomes
Participants With Plasmodium Falciparum (Pf) Infection Detected by Real-Time Polymerase Chain Reaction (RT-PCR)
Time frame: Day 7 through week 24
Maximum Total Plasma Concentration (Cmax) for L9LS
Time frame: Measure through week 24
Time to Maximum Plasma Concentration (TMax) for L9LS - Hours
Time frame: Day 7 post administration of drug
Time to Maximum Plasma Concentration (TMax) for L9LS - Days
Time frame: Measure through week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kassoum Kayentao, MD, MPH, PhD principal investigator
Faculté de Médecine Pharmacie d'Odontostomatologie (FMPOS)
Peter Crompton, MD, MPH principal investigator
National Institutes of Health (NIH)
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 L9LS (VRC-MALMAB0114-00-AB) in people with Plasmodium Falciparum Infection and 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 10 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 2 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Local Adverse Events (AEs) (time frame: Within 7 days after administration of intervention). 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 2 Apr 2025.