Trial to Evaluate CIS43LS in Healthy Adults

NCT ID: NCT04206332

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2022-02-28

Brief Summary

Background:

People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection. Researchers want to test if an experimental drug can help.

Objective:

To test the safety and effectiveness of a drug called CIS43LS that could prevent malaria infection.

Eligibility:

Healthy people ages 18-50 who have never been infected with malaria

Design:

Participants were enrolled on the basis of eligibility criteria, evaluated by clinical laboratory tests, self-reported medical history, and physical examination.

Participants received CIS43LS either infused into a vein in their arm or injected into the fat under the skin. They were monitored for side effects for up to 4 hours after they received the drug. Participants received a thermometer and recorded their temperature and symptoms every day on/with/via a diary card for 7 days after administration. The administration site was checked for redness, swelling, itching or bruising.

Participants had up to 12 follow-up visits. At follow-up visits, participants had blood drawn and were checked for health changes or problems.

Most participants who received CIS43LS took part in a Controlled Human Malaria Infection Challenge (CHMI) along with control participants who did not receive CIS43LS. During the CHMI, mosquitoes carrying the malaria parasite bit participants in a controlled setting. The participants had clinic visits every day for up to 12 days starting 7 days after the CHMI. Participants were treated right away with antimalarial medication if they tested positive for malaria. Approximately 21 days after the CHMI, participants were treated with antimalarial medication for 3 days.

The study lasted 2-6 months depending on the participant's study group.

Detailed Description

This was a multicenter, three-part, first-in-human, Phase 1, open-label, dose escalation study to evaluate the dose, safety, tolerability and protective efficacy of an anti-malaria human monoclonal antibody, VRC-MALMAB0100-00-AB (CIS43LS). The primary objective was to evaluate the safety and tolerability of CIS43LS when administered by either intravenous (IV) or subcutaneous (SC) routes. The secondary objectives were to evaluate the pharmacokinetics of CIS43LS at each dose level, determine if IV or SC administration will confer protection following a controlled human malaria infection (CHMI), and estimate the lowest protective dose of CIS43LS.

Part A: Part A evaluated the doses and routes in an open-label, dose escalation design.

Part B: Part B evaluated CIS43LS doses and routes prior to CHMI in participants previously enrolled in Part A and new Part B enrollees. A subgroup of participants from Part A continued to Part B, and some received a second CIS43LS dose intravenously. Additional participants were enrolled in Part B and received CIS43LS intravenously.

Part C: Part C evaluated CIS43LS doses and routes needed to reach a threshold of protection by assessing serum concentration prior to CHMI in a dose down design.

Study Product:

CIS43LS is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that was developed and manufactured by the National Institutes of Health (NIH) Vaccine Research Center (VRC). A recombinant Chinese hamster ovary DG44 clonal cell line14 developed by the Vaccine Production Program was transferred to the VRC pilot plant for clinical material manufacture. The study product was manufactured according to Good Manufacturing Practice at the VRC pilot plant operated by the Vaccine Clinical Materials Program, Leidos Biomedical Research (Frederick, MD, USA).

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Participants:

A total of 71 participants enrolled in the study as follows:

Part A: 29 participants enrolled in Groups 1-5

Part B: 21* participants enrolled in Groups 6-10

*Out of the 21 Part B participants, 11 were newly enrolled and 10 were Part A participants who re-enrolled.

Of the 10 Part A participants who re-enrolled in Part B, 3 were back up participants who did not receive additional CIS43LS or CHMI and were terminated early because they were not needed.

Therefore, only 18 participants were actively enrolled in Part B: 11 newly enrolled and 7 Part A participants who re-enrolled.

Part C: 31 participants enrolled in Groups 11-16

Of the 71 participants enrolled, 47 participants received at least one dose of CIS43LS and 43 participants completed the CHMI.

Of the 47 participants who received CIS43LS, 4 participants who received a dose in Part A were also enrolled in Part B and received a second dose as follows:

• one participant received a 5 mg/kg IV dose in Part A and 20 mg/kg IV dose in Part B,
• one participant received a 5 mg/kg SC dose in Part A and 20 mg/kg IV dose in Part B, and
• two participants received a 20 mg/kg IV dose in Part A and Part B.

Therefore, a total of 51 doses of CIS43LS were administered to 47 participants as follows:

• 7 doses of 1 mg/kg IV
• 8 doses of 5 mg/kg SC
• 8 doses of 5 mg/kg IV
• 3 doses of 10 mg/kg IV
• 4 doses of 10 mg/kg SC
• 9 doses of 20 mg/kg IV and
• 12 doses of 40 mg/kg IV

Study Duration:

Participants who received CIS43LS were followed for up to 24 weeks after product administration. Control participants were followed through 7 weeks after CHMI.

Conditions

Malaria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Part A, Group 1: CIS43LS (5 mg/kg IV)

CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Part A, Group 2: CIS43LS (5 mg/kg SC)

CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Part A, Group 3: CIS43LS (20 mg/kg IV)

CIS43LS (20 mg/kg) administered by IV infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Part A, Group 4A: CIS43LS (40 mg/kg IV)

CIS43LS (40 mg/kg) administered by IV infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Part A, Group 4B: CIS43LS (40 mg/kg IV)

CIS43LS (40 mg/kg) administered by IV infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Part A, Group 5: CHMI Controls

Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI); however, Group 5 did not undergo CHMI because of restrictions related to coronavirus disease 2019 (COVID-19)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Part B, Group 6: CIS43LS (5 mg/kg SC)

CIS43LS (5 mg/kg) administered by SC injection (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part B, Group 7: CIS43LS (20 mg/kg IV)

CIS43LS (20 mg/kg) administered by IV infusion (Day 0)

Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part B, Group 8: CHMI [CIS43LS (40 mg/kg IV) in Part A]

Part B, Group 8 participants included participants previously enrolled in Part A who received CIS43LS (40 mg/kg IV) in the first part of the study but did not receive CIS43LS in Part B of the study. Group 8 participants were enrolled to complete the controlled human malaria infection (CHMI).

Group Type: OTHER

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part B, Group 9: CIS43LS (40 mg/kg IV)

CIS43LS (40 mg/kg) administered by IV infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part B, Group 10: CHMI Controls

Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI)

Group Type: OTHER

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part C, Group 11: CIS43LS (1 mg/kg IV)

CIS43LS (1 mg/kg) administered by IV infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part C, Group 12: CIS43LS (5 mg/kg IV)

CIS43LS (5 mg/kg) administered by IV infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part C, Group 13: CIS43LS (5 mg/kg SC)

CIS43LS (5 mg/kg) administered by SC injection (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part C, Group 14: CIS43LS (10 mg/kg IV)

CIS43LS (10 mg/kg) administered by IV infusion (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part C, Group 15: CIS43LS (10 mg/kg SC)

CIS43LS (10 mg/kg) administered by SC injection (Day 0)

Group Type: EXPERIMENTAL

VRC-MALMAB0100-00-AB

Intervention Type: DRUG

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Part C, Group 16: CHMI Controls

Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI)

Group Type: OTHER

Plasmodium falciparum (P. falciparum) sporozoite challenge

Intervention Type: OTHER

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Interventions

VRC-MALMAB0100-00-AB

VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.

Intervention Type: DRUG

Plasmodium falciparum (P. falciparum) sporozoite challenge

Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).

Intervention Type: OTHER

Other Intervention Names

CIS43LS

Eligibility Criteria

Inclusion Criteria

1. Able and willing to complete the informed consent process

2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process

3. Available for clinical follow-up through the last study visit

4. 18 to 50 years of age

5. In good general health without clinically significant medical history

6. Physical examination without clinically significant findings within the 56 days prior to enrollment

7. Weight <= 115 kg (for all groups except Groups 5, 10, and 16) and < 100 kg for Group 15

8. Adequate venous access if assigned to an IV group or adequate subcutaneous tissue if assigned to an SC group

9. Willing to have blood samples collected, stored indefinitely, and used for research purposes

10. Agrees to participate in a controlled human malaria infection (CHMI) and to comply with post-CHMI follow-up requirements (except Group 4B)

11. Agrees to refrain from blood donation to blood banks for 3 years following participation in CHMI (except Group 4B)

12. Agrees not to travel to a malaria endemic region during the entire course of study participation

Laboratory Criteria within 56 days prior to enrollment:

13. White Blood Cell (WBC) 2,500-12,000/mm^3

14. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval

15. Platelets = 125,000 - 500,000/mm^3

16. Hemoglobin within institutional normal range or accompanied by the PI or designee approval

17. Creatinine <= 1.1 x upper limit of normal (ULN)

18. Alanine aminotransferase (ALT) <= 1.25 x ULN

19. Negative for HIV infection by an FDA approved method of detection

Laboratory Criteria documented any time prior to enrollment:

20. Negative sickle cell screening test

21. Negative troponin test (except Group 4B)

22. Electrocardiogram (ECG) without clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by a cardiologist to be clinically insignificant as related to study participation do not preclude study enrollment (except Group 4B)

23. No evidence of increased cardiovascular disease risk; defined as >10% five-year risk by the non-laboratory method (except Group 4B)

Criteria Specific to Women:

24. Postmenopausal for at least 1 year, post-hysterectomy or bilateral oophorectomy, or if of childbearing potential:

1. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration and CHMI, and

2. Agrees to use an effective means of birth control through the duration of study participation

Exclusion Criteria

1. Woman who is breast-feeding or planning to become pregnant during study participation

2. Previous receipt of a malaria vaccine

3. History of malaria infection

4. History of severe infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) defined per FDA guidance

5. Active SARS-CoV-2 infection

6. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study

7. Hypertension that is not well controlled

8. Receipt of any investigational study product within 28 days prior to enrollment (note: Emergency Use Authorization Coronavirus Disease 2019 (COVID-19) vaccine is not exclusionary)

9. Receipt of any live attenuated vaccines within 28 days prior to enrollment

10. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws

11. History of a splenectomy, sickle cell disease or sickle cell trait

12. History of skeeter syndrome or anaphylactic response to mosquito-bites (except Group 4B)

13. Known intolerance to chloroquine phosphate, atovaquone or proguanil (except Group 4B)

14. Use or planned use of any drug, including antibiotics, with antimalarial activity within 4 weeks prior to CHMI

15. History of psoriasis or porphyria, which may be exacerbated after treatment with chloroquine (except Group 4B)

16. Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin (except Group 4B)

17. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials Program Leadership:ctpleadership@mail.nih.gov

Role: STUDY_DIRECTOR

VRC, National Institute of Allergy and Infectious Diseases, National Institutes of Health

Locations

University of Maryland Baltimore, Center for Vaccine Development

Baltimore, Maryland, United States

VRC Clinic, NIH Clinical Center

Bethesda, Maryland, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Kayentao K, Ongoiba A, Preston AC, Healy SA, Doumbo S, Doumtabe D, Traore A, Traore H, Djiguiba A, Li S, Peterson ME, Telscher S, Idris AH, Kisalu NK, Carlton K, Serebryannyy L, Narpala S, McDermott AB, Gaudinski M, Traore S, Cisse H, Keita M, Skinner J, Hu Z, Zeguime A, Ouattara A, Doucoure M, Dolo A, Djimde A, Traore B, Seder RA, Crompton PD; Mali Malaria mAb Trial Team. Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali. N Engl J Med. 2022 Nov 17;387(20):1833-1842. doi: 10.1056/NEJMoa2206966. Epub 2022 Oct 31.

Reference Type: BACKGROUND

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Reference Type: RESULT

PMID: 34379916 (View on PubMed)

Lyke KE, Berry AA, Mason K, Idris AH, O'Callahan M, Happe M, Strom L, Berkowitz NM, Guech M, Hu Z, Castro M, Basappa M, Wang L, Low K, Holman LA, Mendoza F, Gordon IJ, Plummer SH, Trofymenko O, Strauss KS, Joshi S, Shrestha B, Adams M, Chagas AC, Murphy JR, Stein J, Hickman S, McDougal A, Lin B, Narpala SR, Vazquez S, Serebryannyy L, McDermott A, Gaudinski MR, Capparelli EV, Coates EE, Wu RL, Ledgerwood JE, Dropulic LK, Seder RA; VRC 612 Part C Study Team. Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial. Lancet Infect Dis. 2023 May;23(5):578-588. doi: 10.1016/S1473-3099(22)00793-9. Epub 2023 Jan 25.

Reference Type: RESULT

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-I-0017.html

NIH Clinical Center Detailed Web Page

Other Identifiers

20-I-0017

Identifier Type: -

Identifier Source: secondary_id

200017

Identifier Type: -

Identifier Source: org_study_id