A Phase 2 interventional study of VRC-MALMAB0100-00-AB (CIS43LS) and Normal saline 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 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.
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, tolerability, and efficacy of VRC MALMAB0100-00-AB (CIS43LS), a human monoclonal antibody, against naturally occurring Plasmodium falciparum (Pf) infection.
This study will evaluate the safety, tolerability, and efficacy of VRC MALMAB0100-00-AB (CIS43LS), a human monoclonal antibody, against naturally occurring Plasmodium falciparum (Pf) infection.
The first part of the study is an open-label dose-escalation study for safety and tolerability. Participants will be assigned to one of three dose arms. Dosing will begin in the lowest dose arm. Once all participants in that arm reach Day 7 post-infusion, if no safety concerns have arisen, dosing will begin at the subsequent dose level. This process will be repeated until participants complete the third dose arm. Participants will be followed for safety to assess adverse events (AEs) at study visits 1, 3, 7, 14, 21, and 28 days after administration, then monthly through 24 weeks after administration.
After the last subject in the highest dose arm reaches Day 7 safety follow-up, an interim safety evaluation will be performed before enrollment begins for the second part of the study.
The second part of the study is a randomized, double-blind, placebo-controlled trial to assess safety and protective efficacy of CIS43LS and placebo. Participants in the efficacy study will receive the study agent and be followed at study visits 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examinations and blood collection for identification of Pf infection 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 348 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.
Females of must be willing to use reliable from 21 days prior to study day 0 through the final study visit as described below.
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.
Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
Biological: VRC-MALMAB0100-00-AB (CIS43LS)
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
Biological: VRC-MALMAB0100-00-AB (CIS43LS)
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
Biological: VRC-MALMAB0100-00-AB (CIS43LS)
Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
Biological: VRC-MALMAB0100-00-AB (CIS43LS)
Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.
Biological: VRC-MALMAB0100-00-AB (CIS43LS)
Participants receive placebo as one time intravenous infusion on Day 0.
Other: Normal saline
Administered via one-time intravenous infusion
Administered via one-time intravenous infusion
Participants With Local Adverse Events (AEs)
Participants with incidence of local adverse events occurring within 7 days after administration of CIS43LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion.
Time frame: Within 7 days after administration of CIS43LS
Severity of Local Adverse Events (AEs)
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 the administration of CIS43LS
Participants With Systemic Adverse Events (AEs)
Participants with incidence of systemic adverse events occurring within 7 days after product administration of CIS43LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain.
Time frame: Within 7 days after the administration of CIS43LS
Severity of Systemic Adverse Events (AEs)
The severity of systemic AEs occurring after the administration of CIS43LS 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 CIS43LS
Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until week 24.
Time frame: Day 7 through week 24 (168 days) after administration of intervention
Participants With Plasmodium Falciparum (Pf) Infection Detected by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by reverse transcription polymerase chain reaction (RT-PCR) using dried blood spot specimen collected from participants from day 21 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until 24 weeks. Plasmodium 18S rRNA RT-PCR assay was applied to dried blood spots during analysis.
Time frame: Day 21 through week 24 (168 days) after administration of intervention
Maximum Serum Concentration (Cmax) for CIS43LS
Maximum serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration to assess durability of CIS43LS and allow for correlation with Plasmodium falciparum (Pf) infection risk. Cmax is the peak serum concentration that CIS43LS achieves after it has been administered. It is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group and measured by a Meso Scale Discovery LLC-based automation platform.
Time frame: Measured through Week 24
Time to Maximum Serum Concentration (Tmax) for CIS43LS
Time to maximum total serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration. Tmax is the time it takes to reach Cmax of CIS43LS after it has been administered; it is determined based on the summary PK curve for each dose group. This was calculated by subtracting the time the CIS43LS intravenous infusion was stopped from the time the blood was collected for the Cmax, at the post-one hour blood draw.
Time frame: One to 24 hours post-infusion
| Milestone | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|
| Started | 6 | 0 | 0 | 0 | 0 | 0 |
| Completed | 6 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|
| Started | 0 | 6 | 0 | 0 | 0 | 0 |
| Completed | 0 | 6 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 6 | 0 | 0 | 0 |
| Completed | 0 | 0 | 6 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 110 | 110 | 110 |
| Completed | 0 | 0 | 0 | 105 | 104 | 102 |
| Not completed | 0 | 0 | 0 | 5 | 6 | 8 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 5 | 6 | 8 |
Participants with incidence of local adverse events occurring within 7 days after administration of CIS43LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion.
| Participants | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS |
|---|---|---|---|
| Injection site swelling | 1 | 0 | 0 |
| Pain at injection site | 2 | 2 | 0 |
| Tenderness at injection site | 0 | 0 | 0 |
| Redness at injection site | 0 | 0 | 0 |
| Bruising at injection site | 1 | 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 | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS |
|---|---|---|---|
| Grade 1 | 4 | 2 | 0 |
| Grade 2 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 |
Participants with incidence of systemic adverse events occurring within 7 days after product administration of CIS43LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain.
| Participants | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS |
|---|---|---|---|
| Fever | 0 | 0 | 0 |
| Feeling unusually tired or unwell | 0 | 0 | 0 |
| Muscle aches | 0 | 0 | 0 |
| Headache | 1 | 1 | 0 |
| Chills | 0 | 0 | 0 |
| Nausea | 0 | 0 | 0 |
| Joint pain | 0 | 0 | 0 |
The severity of systemic AEs occurring after the administration of CIS43LS 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 | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS |
|---|---|---|---|
| Grade 1 | 1 | 1 | 0 |
| Grade 2 | 0 | 0 | 0 |
| 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 smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until week 24.
| Participants | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination | 39 | 20 | 86 |
Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by reverse transcription polymerase chain reaction (RT-PCR) using dried blood spot specimen collected from participants from day 21 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until 24 weeks. Plasmodium 18S rRNA RT-PCR assay was applied to dried blood spots during analysis.
| Participants | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|
| Participants With Plasmodium Falciparum (Pf) Infection Detected by Reverse Transcription Polymerase Chain Reaction (RT-PCR) | 48 | 29 | 96 |
Maximum serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration to assess durability of CIS43LS and allow for correlation with Plasmodium falciparum (Pf) infection risk. Cmax is the peak serum concentration that CIS43LS achieves after it has been administered. It is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group and measured by a Meso Scale Discovery LLC-based automation platform.
| µg/mL | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS |
|---|---|---|---|---|---|
| Maximum Serum Concentration (Cmax) for CIS43LS | 120.98 ± 22.41 | 280.52 ± 40.56 | 897.21 ± 105.41 | 239.62 ± 62.77 | 1033.63 ± 286.52 |
Time to maximum total serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration. Tmax is the time it takes to reach Cmax of CIS43LS after it has been administered; it is determined based on the summary PK curve for each dose group. This was calculated by subtracting the time the CIS43LS intravenous infusion was stopped from the time the blood was collected for the Cmax, at the post-one hour blood draw.
| Hours | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS |
|---|---|---|---|---|---|
| Time to Maximum Serum Concentration (Tmax) for CIS43LS | 0.561 ± 0.040 | 0.556 ± 0.054 | 0.583 ± 0.033 | 1.954 ± 5.390 | 0.597 ± 0.115 |
Collected over Up to 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | 1/110 (0.9%) | 1/110 (0.9%) | 49/110 (44.5%) |
| Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | 0/110 (0%) | 1/110 (0.9%) | 40/110 (36.4%) |
| Efficacy Study: Arm 3: Placebo | 0/110 (0%) | 2/110 (1.8%) | 61/110 (55.5%) |
| Event | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|
| AppendectomySurgical and medical procedures | 0/6 | 0/6 | 0/6 | 0/110 | 0/110 | 1/110 |
| Inguinal Hernia RepairSurgical and medical procedures | 0/6 | 0/6 | 0/6 | 0/110 | 1/110 | 0/110 |
| Umbilical Hernia RepairSurgical and medical procedures | 0/6 | 0/6 | 0/6 | 0/110 | 0/110 | 1/110 |
| HypersplenismBlood and lymphatic system disorders | 0/6 | 0/6 | 0/6 | 1/110 | 0/110 | 0/110 |
| Event | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo |
|---|---|---|---|---|---|---|
| RhinitisInfections and infestations | 4/6 | 5/6 | 4/6 | 18/110 | 18/110 | 18/110 |
| HeadacheNervous system disorders | 3/6 | 5/6 | 4/6 | 45/110 | 40/110 | 51/110 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/6 | 4/6 | 0/6 | 4/110 | 10/110 | 8/110 |
| Respiratory DisorderRespiratory, thoracic and mediastinal disorders | 4/6 | 3/6 | 3/6 | 49/110 | 25/110 | 32/110 |
| MalariaInfections and infestations | 3/6 | 2/6 | 2/6 | 26/110 | 16/110 | 61/110 |
| NeutropeniaBlood and lymphatic system disorders | 0/6 | 2/6 | 0/6 | 7/110 | 2/110 | 2/110 |
| Abdominal Pain UpperGastrointestinal disorders | 2/6 | 1/6 | 0/6 | 4/110 | 5/110 | 4/110 |
| Dental CariesGastrointestinal disorders | 2/6 | 0/6 | 1/6 | 11/110 | 8/110 | 4/110 |
| DiarrhoeaGastrointestinal disorders | 2/6 | 1/6 | 0/6 | 2/110 | 4/110 | 2/110 |
| GastritisGastrointestinal disorders | 2/6 | 1/6 | 0/6 | 14/110 | 10/110 | 20/110 |
| Age, Customized(Participants) | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|
| 18-20 years | 0 | 1 | 1 | 9 | 13 | 10 | 34 |
| 21-30 years | 1 | 1 | 1 | 34 | 25 | 31 | 93 |
| 31-40 years | 2 | 0 | 1 | 39 | 36 | 41 | 119 |
| 41-50 years | 3 | 4 | 3 | 23 | 34 | 26 | 93 |
| 51-55 years | 0 | 0 | 0 | 5 | 2 | 2 | 9 |
| Sex: Female, Male(Participants) | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Female | 3 | 2 | 2 | 51 | 47 | 44 | 149 |
| Male | 3 | 4 | 4 | 59 | 63 | 66 | 199 |
| Race/Ethnicity, Customized(Participants) | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Black or African | 6 | 6 | 6 | 110 | 110 | 110 | 348 |
| Region of Enrollment(Participants) | Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS | Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS | Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS | Efficacy Study: Arm 1: 10 mg/kg of CIS43LS | Efficacy Study: Arm 2: 40 mg/kg of CIS43LS | Efficacy Study: Arm 3: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mali | 6 | 6 | 6 | 110 | 110 | 110 | 348 |
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