Anti-malaria MAb in Malian Children | NCT05304611

NCT05304611

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
National Institutes of Health (NIH)	NIH
Malaria Research and Training Center, Bamako, Mali	OTHER
University of the Sciences, Techniques and Technologies of Bamako	OTHER

Oversight Module

Description Module

Detailed Description

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult Dose-escalation study: Arm 1: 300 mg of L9LS	Experimental	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 Dose-escalation study: Arm 2: 600 mg of L9LS	Experimental	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 Dose-escalation study: Arm 3: 20 mg/kg of L9LS	Experimental	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 Dose-escalation study: Arm 1: 150 mg of L9LS	Experimental	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 Dose-escalation study: Arm 2: 300 mg of L9LS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection	Biological	Administered one time via subcutaneous route.	Adult Dose-escalation study: Arm 1: 300 mg of L9LS Adult Dose-escalation study: Arm 2: 600 mg of L9LS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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	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.	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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is within the appropriate age range for the respective cohort:
1. Children: Aged ≥6 years and <11 years.
2. Adults: Aged ≥18 years.
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.
Adult participants or parent and/or guardian of minor participants able to provide informed consent.
Willing to have blood samples and data stored for future research.
Resides in or near Kalifabougou or Torodo, Mali, and available for the duration of the study.
For the adult cohort, 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 test performed per protocol.

Year 2 Extension Inclusion Criteria:

Participated in the first year of the protocol.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
In good general health and without clinically significant medical history.
Parent and/or guardian able to provide informed consent.
Willing to have blood samples and data stored for future research.
Resides in or near Kalifabougou or Torodo, Mali, and available for the duration of the study.

Exclusion Criteria:

Body weight <15 kg or >30 kg for children, or >60 kg for adults.
Currently receiving or planning to receive seasonal malaria chemoprevention (SMC).
Any history of menses (for 6-10 year old cohort) or positive pregnancy test at screening (for adult cohort).
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.
Subject (for adult subjects) or parental (for minor subjects) 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.)
Infected with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)
Clinically significant abnormal electrocardiogram (ECG; Corrected QT Interval (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 before the last required protocol visit. (Note: Past, current, or planned participation in observational studies 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).
Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors).
Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
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 or COVID-19 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.
Clinical signs of malnutrition.
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.

Year 2 Extension Exclusion Criteria:

Currently receiving or planning to receive SMC.
Any history of menses.
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.
Parental 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.)
Infected with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)
Clinically significant abnormal electrocardiogram (ECG; QTc >460 or other significant abnormal findings, including unexplained tachycardia or bradycardia).
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
Receipt of any investigational product within the past 30 days.
Participation or planned participation in another interventional trial with an investigational product other than L9LS until the last required protocol visit. (Note: Past, current, or planned participation in observational studies 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).
Currently active salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors).
Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
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 or COVID-19 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 any other monoclonal antibody other than L9LS in the last 5 years.
Known allergies or contraindication against artemether-lumefantrine.
Clinical signs of malnutrition.
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.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Kassoum Kayentao, MD, MPH, PhD	Faculté de Médecine Pharmacie d'Odontostomatologie (FMPOS)	Principal Investigator
Peter Crompton, MD, MPH	National Institutes of Health (NIH)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kalifabougou MRTC Clinic		Kalifabougou	Koulikoro		Mali
Torodo MRTC Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38669354	Result	Kayentao K, Ongoiba A, Preston AC, Healy SA, Hu Z, Skinner J, Doumbo S, Wang J, Cisse H, Doumtabe D, Traore A, Traore H, Djiguiba A, Li S, Peterson ME, Telscher S, Idris AH, Adams WC, McDermott AB, Narpala S, Lin BC, Serebryannyy L, Hickman SP, McDougal AJ, Vazquez S, Reiber M, Stein JA, Gall JG, Carlton K, Schwabl P, Traore S, Keita M, Zeguime A, Ouattara A, Doucoure M, Dolo A, Murphy SC, Neafsey DE, Portugal S, Djimde A, Traore B, Seder RA, Crompton PD; Mali Malaria mAb Trial Team. Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria. N Engl J Med. 2024 May 2;390(17):1549-1559. doi: 10.1056/NEJMoa2312775. Epub 2024 Apr 26.

IPD Sharing Statement Module

365 participants were consented (341 pediatrics, 36 adults):

62 participants were ineligible (57 pediatrics, five adults)
23 participants served as backup (22 pediatrics, one adult)
One pediatric participant withdrew consent
279 participants received intervention (261 pediatrics, 18 adults) in year one
235 pediatric participants from year one participated in the extension study in year two

Arm/Group Information

ID	Title	Description
FG000	Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	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. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
FG001	Adult Dose-escalation Study: Arm 2: 600 mg of L9LS	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. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
FG002	Adult Dose-escalation Study: Arm 3: 20 mg/kg of L9LS	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. L9LS (VRC-MALMAB0114-00-AB): Administered one time via intravenous route.
FG003	Pediatric Dose-escalation Study: Arm 1: 150 mg of L9LS	Pediatric subjects ages 6-10 years receive 150 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for arm 2. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
FG004	Pediatric Dose-escalation Study: Arm 2: 300 mg of L9LS	Pediatric subjects ages 6-10 years receive 300 mg of L9LS subcutaneously. Once subjects reach day 7 post-administration without safety concerns, dosing begins for the pediatric efficacy study arms. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
FG005	Pediatric Dose-escalation Study: Arm 3: Placebo	Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously. Normal saline: Administered one time via subcutaneous administration.
FG006	Pediatric Efficacy Study: Arm 1: 150 mg of L9LS	Pediatric subjects ages 6-10 receive 150 mg of L9LS subcutaneously. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
FG007	Pediatric Efficacy Study: Arm 2: 300 mg of L9LS	Pediatric subjects ages 6-10 receive 300 mg of L9LS subcutaneously. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
FG008	Pediatric Efficacy Study: Arm 3: Placebo	Pediatric subjects ages 6-10 receive placebo of normal saline subcutaneously. Normal saline: Administered one time via subcutaneous administration.
FG009	Pediatric Extension Study: Arm 1: 150 mg of L9LS	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.
FG010	Pediatric Extension Study: Arm 2: 300 mg of L9LS	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.
FG011	Pediatric Extension Study: Arm 3: Placebo	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.

Periods

Title

Milestones

Reasons Not Completed

Adult Dose-escalation: 300 mg L9LS

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
COMPLETED		FG0006 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Adult Dose-escalation: 600 mg L9LS

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0016 subjects FG0020 subjects FG003

Adult Dose-escalation: 20 mg/kg L9LS

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0026 subjects FG003

Ped Dose-escalation: 150mg L9LS/ Placebo

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Ped Dose-escalation: 300mg L9LS/ Placebo

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Pediatric Efficacy Study

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Pediatric Extension Study

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	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. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.
BG001

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Modified intention-to-treat (MITT) - Analysis include all randomized subjects that received the study intervention.

Posted

Count of Participants

Participants

Within 7 days after administration of L9LS

ID	Title	Description
OG000	Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	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. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Adult Dose-escalation Study: Arm 1: 300 mg of L9LS	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. L9LS (VRC-MALMAB0114-00-AB): Administered one time via subcutaneous route.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Leukocytosis	Blood and lymphatic system disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Peter Crompton	National Institute of Allergy and Infectious Diseases (NIAID)	301-761-5042		pcrompton@niaid.nih.gov

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 14, 2024	May 30, 2024	Prot_SAP_000.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D008288	Malaria

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Intervention Browse Module

ID	Term
D007279	Injections, Subcutaneous
D007275	Injections, Intravenous

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Masking Info

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

Pediatric Extension study: Arm 1: 150 mg of L9LS

Pediatric Extension study: Arm 2: 300 mg of L9LS

EG0000 affected6 at risk

EG0010 affected6 at risk

EG0020 affected6 at risk

EG0031 affected9 at risk

EG0040 affected9 at risk

EG0050 affected18 at risk

EG0060 affected75 at risk

EG0071 affected75 at risk

EG0081 affected75 at risk

EG0090 affected79 at risk

EG0100 affected38 at risk

EG0112 affected118 at risk

Title	Measurements
	OG0000 OG0010 OG0020

Title	Measurements
	OG0000 OG0010 OG0020

Title	Measurements
	OG0001 OG0011 OG0023