A Phase 2 interventional study of L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection and L9LS (VRC-MALMAB0114-00-AB) intravenous injection in Plasmodium Falciparum Infection and Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in Mali. Open to participants aged 6 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of L9LS in healthy Malian children, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 7-month malaria season in healthy Malian children 6-10 years of age.
A two-part, phase 2 trial evaluating the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of L9LS in healthy Malian children, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 7-month malaria season in healthy Malian children 6-10 years of age.
The first part of the study is an age de-escalation and dose-escalation study for safety and tolerability. Adult subjects in the dose-escalation study will be assigned in open-label fashion to 1 of 3 L9LS dose arms. Dosing will begin in the lowest dose arm. Once all subjects in that arm reach day 7 post-administration, if no safety concerns have arisen, dosing will begin at the next dose level. Once all subjects in that arm reach day 7 post-administration, if no safety concerns have arisen, dosing will begin at the highest dose level. Once all adult subjects reach day 7 post-administration, if no safety concerns have arisen, 18 subjects aged 6-10 years will be randomized 1:1 to L9LS or placebo in double-blind fashion. Once all 18 subjects reach day 7 post-administration, if no safety concerns have arisen, an additional 18 subjects aged 6-10 years will be randomized 1:1 to L9LS versus placebo. Randomization of subjects aged 6-10 years in each L9LS dose arm will be weight-stratified and enrollment will be weight de-escalated. Adult subjects will be followed for safety to assess adverse events (AEs) at study visits 1, 3, 7, 14, 21, and 28 days after administration, and once every month thereafter through 28 weeks. Subjects aged 6-10 years will be followed at study visits 1, 3, 7, 14, 21, and 28 days after administration, and once every 2 weeks thereafter through 36 weeks. Primary study assessments include physical examination and blood collection for identification of Pf infection and other research laboratory evaluations. After the last subject in the pediatric L9LS dose arm reaches day 7 safety follow-up, an interim safety evaluation will be performed before enrollment begins for the efficacy part of the study. Data from the 36 subjects aged 6-10 years enrolled in the dose-escalation study will be included in a secondary analysis to determine the relationship between L9LS concentration and the risk of Pf infection.
The second part of the study is a weight-stratified, randomized, double-blind, placebo-controlled trial to assess safety and protective efficacy of L9LS versus placebo administered SC in children 6-10 years of age. In this part of the study, subjects will be randomized to L9LS or placebo. Randomization of subjects in each arm will be weight-stratified. Subjects in the efficacy study will receive the study agent prior to the malaria season 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.
Prior to the last study visit of the original protocol described above (January 2023 - February 2023), study participants who remain enrolled in the dose-escalation and efficacy studies will be invited to participate in a 12-month extension study. After the safety and efficacy results are unblinded (approximately March/April 2023), participants who agree to continue with the extension will be grouped into one of 3 arms based on their original study arm assignment:
Arm 1: Up to 84 subjects who received 150 mg of L9LS in year 1 (9 from the dose-escalation study, plus 75 from the efficacy study).
Arm 2: Up to 84 subjects who received 300 mg of L9LS in year 1 (9 from the dose-escalation study, plus 75 from the efficacy study).
Arm 3: Up to 93 subjects who received placebo in year 1 (18 from the dose-escalation study, plus 75 from the efficacy study).
The protocol extension employs a pre-specified, adaptive design based on the time-to-event efficacy of 150 mg and 300 mg of L9LS against P. falciparum infection as detected by blood smear observed after the first malaria season in the original protocol. Specifically, if 150 mg and 300 mg of L9LS both show ≥60% efficacy during the first malaria season (based on the upper bound of the two-sided 95% confidence interval [CI]), participants will be re-randomized 1:1 in a double-blind fashion within each arm to receive a single dose of either L9LS (150 or 300 mg depending on study arm) or placebo administered SC before the 2023 malaria season.
The same randomization scheme will be followed if in the first malaria season the 300-mg dose of L9LS shows ≥60% efficacy (based on the upper bound of the two-sided 95% CI) and the 150-mg dose of L9LS shows \<60% efficacy (based on the upper bound of the two-sided 95% CI) but the difference between their respective point estimates of efficacy is ≤10%, with the exception that children who received placebo in year 1 will receive 300 mg of L9LS (or placebo) in year 2.
If 300 mg of L9LS shows ≥60% efficacy (based on the upper bound of the two-sided 95% CI) and 150 mg of L9LS shows \<60% efficacy (based on the upper bound of the two-sided 95% CI) but the difference between their respective point estimates of efficacy is >10% during the first malaria season, participants will be re-randomized 1:1 in a double-blind fashion within each arm to receive a single dose of either 300 mg of L9LS or placebo administered SC before the 2023 malaria season.
If 150 mg and 300 mg of L9LS both show \<60% efficacy (based on the upper bound of the two-sided 95% CI) after the first malaria season, the protocol extension will be abandoned.
Before study agent administration, all subjects will be given artemether-lumefantrine to clear any preexisting Pf blood-stage infection.
Subjects will be followed at study visits 1, 3, 7, 14, 21, and 28 days after administration, and once every 2 weeks thereafter through 28 weeks, with a final visit occurring on study day 252 (36 weeks) to collect a final PK sample. Primary study assessments include medical history, physical examination, and blood collection for pharmacokinetics (PK), anti-drug antibody (ADA) assessments, identification of Pf infection by microscopic examination of thick blood smears and RT-PCR, and other research laboratory evaluations.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 365 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Is within the appropriate age range for the respective cohort:
For the adult cohort, females of must be willing to use reliable from 21 days prior to study day 0 through the final study visit as described below.
Year 2 Extension Inclusion Criteria:
Exclusion Criteria:
Year 2 Extension Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants receive single dose of 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Adult participants receive single dose of 600 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Adult participants receive highest single dose of 20 mg/kg IV of L9LS intravenously. Once subjects reach day 7 post-administration without safety concerns dosing begins for pediatric subjects dose escalation arm 1.
Biological: L9LS (VRC-MALMAB0114-00-AB) intravenous injection
Pediatric subjects ages 6-10 years receive single dose of 150 mg L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Pediatric subjects ages 6-10 years receive single dose of 300 mg L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Pediatric subjects ages 6-10 receive single dose placebo of normal saline subcutaneously for comparison.
Other: Placebo
Pediatric subjects ages 6-10 receive single dose of 150 mg L9LS subcutaneously.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Pediatric subjects ages 6-10 receive single dose of 300 mg L9LS subcutaneously.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Pediatric subjects ages 6-10 receive single dose placebo of normal saline subcutaneously.
Other: Placebo
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 150 mg of L9LS subcutaneously.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive 300 mg of L9LS subcutaneously.
Biological: L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection
Pediatric subjects ages 6-10 who completed year one of the study and agreed to continue with the extension were randomized to receive placebo of normal saline subcutaneously.
Other: Placebo
Administered one time via subcutaneous route.
Administered one time via intravenous route.
Normal saline administered one time via subcutaneous route.
Participants With Local Adverse Events (AEs) - Year One
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.
Time frame: Within 7 days after administration of L9LS
Severity of Local Adverse Events (AEs) - Year One
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
Time frame: Within 7 days after administration of L9LS
Participants With Systemic Adverse Events (AEs) - Year One
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.
Time frame: Within 7 days after the administration of L9LS
Severity of Systemic Adverse Events (AEs) - Year One
The severity of systemic AEs occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; 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
Time frame: Within 7 days after the administration of L9LS
Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination - Efficacy Study
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 14 through week 28 (196 days) after administration of L9LS or placebo. Analysis was done as number of participants who had at least one positive blood smear.
Time frame: Day 7 through week 28
Participants With Detectable Anti-drug Antibody (ADA) in Sera - Extension Study
Number of participants with detectable anti-drug antibody (ADA) in sera after exposure to L9LS. Serum was collected from participants at specific timepoints throughout the study, on days 0, 7, 28, 84, 168, and 196. The tier 3 assay was used to directly measure ADA's ability to impair L9LS binding to Plasmodium falciparum circumsporozoite protein (PfCSP). Analysis was done to determine number of participants with positive or detectable ADA in sera.
Time frame: Measured through week 36
Maximum Total Plasma Concentration (Cmax) for L9LS - Extension Study
Maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles post dose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.
Time frame: Measured through Week 36
Time to Maximum Plasma Concentration (TMax) for L9LS - Extension Study
Time to maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration.
Time frame: Measured through Week 36
Participants With Local Adverse Events (AEs) - Extension Study
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.
Time frame: Within 7 days after administration of L9LS
Severity of Local Adverse Events (AEs) - Extension Study
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
Time frame: Within 7 days after administration of L9LS
Participants With Systemic Adverse Events (AEs) - Extension Study
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.
Time frame: Within 7 days after the administration of L9LS
Severity of Systemic Adverse Events (AEs) - Extension Study
The severity of systemic AEs occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; 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
Time frame: Within 7 days after the administration of L9LS
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 0 through week 28 (196 days) after administration of L9LS or placebo. Analysis was done as number of participants who had at least one positive blood sample.
Time frame: Measured through week 24 (dose escalation study) and week 28 (efficacy study)
Participants With Clinical Malaria - Pediatric Dose Escalation Study
Number of pediatric participants with clinical malaria during a single malaria season, defined by an illness accompanied by measured axillary fever ≥37.5°C, or history of fever (subjective or objective) in the previous 24 hours, and Plasmodium falciparum (Pf) asexual parasitemia \>5,000 parasites/μL as detected from microscopic examination of thick blood smear. Assessment was done from day 0 through week 28 (196 days) after administration of L9LS or placebo. Subjective data, objective data and blood sample were collected from administration of intervention through week 28. Analysis was done as number of participants who had at least one symptom and positive blood sample.
Time frame: Measured through Week 28
Participants With Clinical Malaria - Pediatric Efficacy Study
Number of pediatric participants with clinical malaria during a single malaria season, defined by an illness accompanied by measured axillary fever ≥37.5°C, or history of fever (subjective or objective) in the previous 24 hours, and Plasmodium falciparum (Pf) asexual parasitemia \>5,000 parasites/μL as detected from microscopic examination of thick blood smear. Assessment was done from day 0 through week 28 (196 days) after administration of L9LS or placebo. Subjective data, objective data and blood sample were collected from administration of intervention through week 28. Analysis was done as number of participants who had at least one symptom and positive blood sample.
Time frame: Measured through Week 28
Participants With Clinical Malaria Detected by Microscopic Examination of Thick Blood Smear - Pediatric Dose Escalation Study
Number of participants with clinical malaria during a single malaria season, defined by an illness accompanied by any level of Plasmodium Falciparum (Pf) asexual parasitemia as detected from microscopic examination of thick blood smear that results in the administration of anti-malarial treatment.
Time frame: Measured through Week 28
Participants With Clinical Malaria Detected by Microscopic Examination of Thick Blood Smear - Pediatric Efficacy Study
Number of participants with clinical malaria during a single malaria season, defined by an illness accompanied by any level of Plasmodium Falciparum (Pf) asexual parasitemia as detected from microscopic examination of thick blood smear that results in the administration of anti-malarial treatment.
Time frame: Measured through Week 24
Maximum Total Plasma Concentration (Cmax) for L9LS - Study Year One
Maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 56, 84, 112, 140, 168, 196, 224, \& 252 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles post dose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.
Time frame: Measured through Week 36
Time to Maximum Plasma Concentration (TMax) for L9LS - Study Year One
Time to maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum was collected on days 0, 7, 28, 56, 84, 112, 140, 168, 196, 224, \& 252 after 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.
Time frame: Measured through Week 36
| Milestone | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 9 | 0 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 9 | 0 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 9 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 9 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 75 | 75 | 75 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 73 | 74 | 72 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 3 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrew consent | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 |
| Milestone | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 79 | 38 | 118 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 79 | 37 | 116 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
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.
| Participants | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Injection site swelling | 3 | 1 | 0 | 0 | 0 | 0 | 1 | 3 | 0 |
| Pain at Injection site | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Tenderness at injection site | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Redness at injection site | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Bruising at injection site | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pruritus at injection site | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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
| Participants | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | 3 | 1 | 0 | 0 | 0 | 0 | 2 | 3 | 2 |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Fever | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 |
| Feeling unusually tired or unwell | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Muscle aches | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 |
| Chills | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Joint pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The severity of systemic AEs occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; 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 | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 |
| Grade 2 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 0 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 14 through week 28 (196 days) after administration of L9LS or placebo. Analysis was done as number of participants who had at least one positive blood smear.
| Participants | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination - Efficacy Study | 36 | 30 | 61 |
Number of participants with detectable anti-drug antibody (ADA) in sera after exposure to L9LS. Serum was collected from participants at specific timepoints throughout the study, on days 0, 7, 28, 84, 168, and 196. The tier 3 assay was used to directly measure ADA's ability to impair L9LS binding to Plasmodium falciparum circumsporozoite protein (PfCSP). Analysis was done to determine number of participants with positive or detectable ADA in sera.
| Participants | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Detectable Anti-drug Antibody (ADA) in Sera - Extension Study | 0 | 0 | 0 |
Maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles post dose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.
| ug/mL | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS |
|---|---|---|
| Maximum Total Plasma Concentration (Cmax) for L9LS - Extension Study | 64.63 ± 17.36 | 116.93 ± 24.78 |
Time to maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 84, 140, 196, \& 252 after the administration of L9LS. Tmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles. Analysis was done to determine the time (in days) at which the maximum observed concentration was achieved for each participant and cumulative output was calculated as the central tendency and dispersion metric based on the observed time of maximum concentration.
| Days | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS |
|---|---|---|
| Time to Maximum Plasma Concentration (TMax) for L9LS - Extension Study | 7.00 ± 0.16 | 7.58 ± 3.41 |
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.
| Participants | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|
| Injection site swelling | 1 | 2 | 0 |
| Pain at Injection site | 0 | 0 | 1 |
| Tenderness at injection site | 0 | 0 | 0 |
| Redness at injection site | 0 | 0 | 0 |
| Bruising at injection site | 0 | 0 | 0 |
| Pruritus at injection site | 0 | 0 | 0 |
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
| Participants | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|
| Grade 1 | 1 | 2 | 1 |
| Grade 2 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 |
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.
| Participants | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|
| Fever | 0 | 0 | 0 |
| Feeling unusually tired or unwell | 0 | 0 | 0 |
| Muscle aches | 0 | 0 | 0 |
| Headache | 1 | 1 | 4 |
| Chills | 0 | 0 | 0 |
| Nausea | 0 | 0 | 0 |
| Joint pain | 0 | 0 | 0 |
The severity of systemic AEs occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; 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 | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|
| Grade 1 | 0 | 0 | 1 |
| Grade 2 | 1 | 1 | 3 |
| Grade 3 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 |
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 0 through week 28 (196 days) after administration of L9LS or placebo. Analysis was done as number of participants who had at least one positive blood sample.
| Participants | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|
| Participants With Plasmodium Falciparum (Pf) Infection Detected by Real-Time Polymerase Chain Reaction (RT-PCR) | 7 | 8 | 13 | 33 | 32 | 62 |
Number of pediatric participants with clinical malaria during a single malaria season, defined by an illness accompanied by measured axillary fever ≥37.5°C, or history of fever (subjective or objective) in the previous 24 hours, and Plasmodium falciparum (Pf) asexual parasitemia \>5,000 parasites/μL as detected from microscopic examination of thick blood smear. Assessment was done from day 0 through week 28 (196 days) after administration of L9LS or placebo. Subjective data, objective data and blood sample were collected from administration of intervention through week 28. Analysis was done as number of participants who had at least one symptom and positive blood sample.
| Participants | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Clinical Malaria - Pediatric Dose Escalation Study | 6 | 4 | 11 |
Number of pediatric participants with clinical malaria during a single malaria season, defined by an illness accompanied by measured axillary fever ≥37.5°C, or history of fever (subjective or objective) in the previous 24 hours, and Plasmodium falciparum (Pf) asexual parasitemia \>5,000 parasites/μL as detected from microscopic examination of thick blood smear. Assessment was done from day 0 through week 28 (196 days) after administration of L9LS or placebo. Subjective data, objective data and blood sample were collected from administration of intervention through week 28. Analysis was done as number of participants who had at least one symptom and positive blood sample.
| Participants | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Clinical Malaria - Pediatric Efficacy Study | 21 | 14 | 44 |
Number of participants with clinical malaria during a single malaria season, defined by an illness accompanied by any level of Plasmodium Falciparum (Pf) asexual parasitemia as detected from microscopic examination of thick blood smear that results in the administration of anti-malarial treatment.
| Participants | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Clinical Malaria Detected by Microscopic Examination of Thick Blood Smear - Pediatric Dose Escalation Study | 7 | 7 | 13 |
Number of participants with clinical malaria during a single malaria season, defined by an illness accompanied by any level of Plasmodium Falciparum (Pf) asexual parasitemia as detected from microscopic examination of thick blood smear that results in the administration of anti-malarial treatment.
| Participants | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Clinical Malaria Detected by Microscopic Examination of Thick Blood Smear - Pediatric Efficacy Study | 33 | 25 | 57 |
Maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum collected on days 0, 7, 28, 56, 84, 112, 140, 168, 196, 224, \& 252 after the administration of L9LS. Cmax for L9LS was obtained directly by visual inspection of the plasma concentration versus time profiles post dose. Analysis was done to determine each participant's observed maximum concentration based on all available timepoints and cumulative output was calculated as the central tendency and dispersion metric based on the observed maximum concentrations.
| ug/mL | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS |
|---|---|---|---|---|
| Maximum Total Plasma Concentration (Cmax) for L9LS - Study Year One | 76.97 ± 18.88 | 142.79 ± 30.36 | 76.19 ± 22.04 | 142.70 ± 29.56 |
Time to maximum total plasma concentration (Cmax) following a dose of 150 mg or 300 mg L9LS. Serum was collected on days 0, 7, 28, 56, 84, 112, 140, 168, 196, 224, \& 252 after 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.
| Days | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS |
|---|---|---|---|---|
| Time to Maximum Plasma Concentration (TMax) for L9LS - Study Year One | 7.00 ± 0.00 | 7.00 ± 0.00 | 7.17 ± 2.46 | 7.36 ± 2.45 |
Collected over Up to 196 days for adult dose escalation groups and up to 252 days for the pediatric dose escalation groups, post administration of intervention (year one) Up to 168 days for the efficacy groups, post administration of intervention (year one) Up to 252 days for the extension groups, post administration of intervention (year two). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| Pediatric Dose-escalation Study: Arm 3: Placebo | 0/18 (0%) | 0/18 (0%) | 18/18 (100%) |
| Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | 0/75 (0%) | 0/75 (0%) | 67/75 (89.3%) |
| Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | 0/75 (0%) | 0/75 (0%) | 71/75 (94.7%) |
| Pediatric Efficacy Study: Arm 3: Placebo | 0/75 (0%) | 0/75 (0%) | 72/75 (96%) |
| Pediatric Extension Study: Arm 1: 150 mg of L9LS | 0/79 (0%) | 0/79 (0%) | 74/79 (93.7%) |
| Pediatric Extension Study: Arm 2: 300 mg of L9LS | 0/38 (0%) | 0/38 (0%) | 33/38 (86.8%) |
| Pediatric Extension Study: Arm 3: Placebo | 0/118 (0%) | 0/118 (0%) | 111/118 (94.1%) |
| Event | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Pediatric Extension Study: Arm 1: 150 mg of L9LS | Pediatric Extension Study: Arm 2: 300 mg of L9LS | Pediatric Extension Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MalariaInfections and infestations | 1/6 | 2/6 | 1/6 | 7/9 | 7/9 | 13/18 | 36/75 | 33/75 | 59/75 | 32/79 | 15/38 | 83/118 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 4/6 | 1/6 | 4/6 | 4/9 | 4/9 | 6/18 | 35/75 | 36/75 | 33/75 | 13/79 | 10/38 | 24/118 |
| HeadacheNervous system disorders | 3/6 | 2/6 | 1/6 | 5/9 | 3/9 | 8/18 | 27/75 | 27/75 | 21/75 | 34/79 | 10/38 | 52/118 |
| Injection site swellingGeneral disorders | 3/6 | 1/6 | 0/6 | 0/9 | 0/9 | 0/18 | 2/75 | 4/75 | 0/75 | 1/79 | 2/38 | 0/118 |
| RhinitisRespiratory, thoracic and mediastinal disorders | 1/6 | 2/6 | 1/6 | 4/9 | 3/9 | 3/18 | 19/75 | 26/75 | 27/75 | 17/79 | 9/38 | 24/118 |
| Abdominal painGastrointestinal disorders | 0/6 | 1/6 | 1/6 | 1/9 | 1/9 | 7/18 | 19/75 | 13/75 | 16/75 | 26/79 | 9/38 | 33/118 |
| TachycardiaCardiac disorders | 1/6 | 2/6 | 1/6 | 2/9 | 0/9 | 0/18 | 1/75 | 4/75 | 6/75 | 1/79 | 1/38 | 3/118 |
| GastritisGastrointestinal disorders | 1/6 | 1/6 | 2/6 | 0/9 | 0/9 | 0/18 | 0/75 | 0/75 | 0/75 | 0/79 | 0/38 | 0/118 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/6 | 1/6 | 1/6 | 2/9 | 2/9 | 3/18 | 13/75 | 18/75 | 22/75 | 17/79 | 11/38 | 22/118 |
| NeutropeniaBlood and lymphatic system disorders | 1/6 | 1/6 | 1/6 | 2/9 | 0/9 | 4/18 | 1/75 | 3/75 | 3/75 | 2/79 | 0/38 | 5/118 |
| Age, Customized(Participants) | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| 6 | 0 | 0 | 0 | 0 | 1 | 5 | 20 | 23 | 31 | 80 |
| 7 | 0 | 0 | 0 | 3 | 2 | 4 | 11 | 11 | 8 | 39 |
| 8 | 0 | 0 | 0 | 3 | 2 | 4 | 23 | 13 | 19 | 64 |
| 9 | 0 | 0 | 0 | 1 | 3 | 2 | 15 | 15 | 9 | 45 |
| 10 | 0 | 0 | 0 | 2 | 1 | 3 | 6 | 13 | 8 | 33 |
| 18-20 | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| 21-30 | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| 31-40 | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| 41-50 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| 51-55 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 3 | 4 | 4 | 7 | 3 | 8 | 31 | 33 | 36 | 129 |
| Male | 3 | 2 | 2 | 2 | 6 | 10 | 44 | 42 | 39 | 150 |
| Race/Ethnicity, Customized(Participants) | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| African | 6 | 6 | 6 | 9 | 9 | 18 | 75 | 75 | 75 | 279 |
| Region of Enrollment(participants) | Adult Dose-escalation Study: Arm 1: 300 mg of L9LS | Adult Dose-escalation Study: Arm 2: 600 mg of L9LS | Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS | Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS | Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS | Pediatric Dose-escalation Study: Arm 3: Placebo | Pediatric Efficacy Study: Arm 1: 150 mg of L9LS | Pediatric Efficacy Study: Arm 2: 300 mg of L9LS | Pediatric Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mali | 6 | 6 | 6 | 9 | 9 | 18 | 75 | 75 | 75 | 279 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: 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 at NIH
Ran from Mar 2022 to primary completion in Apr 2024, 25 months.
Results were first posted in Jul 2024, 2 months after primary completion.
Of 39 phase 2 interventional studies under Malaria, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 27. This study's 25 months is above that.
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