Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

• ClinicalTrials.gov Identifier: NCT02639299
• Recruitment Status: Recruiting
• First Posted: December 24, 2015
• Last Update Posted: May 27, 2022
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information

• First Submitted Date: December 23, 2015
• First Posted Date: December 24, 2015
• Last Update Posted Date: May 27, 2022
• Actual Study Start Date: December 8, 2016
• Estimated Primary Completion Date: September 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 16, 2021)

To screen healthy volunteers for [ Time Frame: 1 year ]

identify healthy adults at a low risk of developing complications due to experimental malaria infection, investigational antimalarials and vaccines

• Original Primary Outcome Measures (submitted: December 23, 2015): To screen healthy volunteers for eligibility to enroll in studies to evaluate investigational antimalarial drugs, malaria vaccines, and/orundergo CHMI. [ Time Frame: One Year ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
• Official Title: Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

Brief Summary

Background:

Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under a general screening study in order to see if are qualified to join a future malaria study.

Objective:

To screen healthy volunteers to see if they are eligible to join investigational malaria studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines, or prevention regimens. They may also involve controlled human malaria infection trials.

Eligibility:

Healthy people ages 18 50

Design:

Participants will first be prescreened by phone.

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Participants may go more than 1 year without joining a clinical trial. If this happens, they may be re-contacted to see if they still want to be part of this screening protocol. Those who still want to participate and have had relevant medical changes will be rescreened.

Detailed Description

This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV).

Malaria-related morbidity and mortality have a major economic impact in endemic regions and

present a substantial health risk to non-immune travelers and people living in endemic areas. To stem the worldwide impact of this devastating disease, a safe and broadly effective malaria vaccine and improved antimalarial therapeutics are urgently required.

This screening protocol is designed to continuously evaluate potential healthy volunteers to build a pool of volunteers who may participate in future and ongoing LMIV malaria drug, vaccine, or controlled human malaria infections (CHMI) trials. A complete medical history and blood and urine samples will be obtained to evaluate whether volunteers are eligible for study-specific screening.

• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: healthy volunteers in the Washington, DC region
• Condition: Malaria
• Intervention: Not Provided

Study Groups/Cohorts

Healthy volunteer

healthy, malaria-na(SqrRoot) ve US adults

• Publications *: YOELI M. STUDIES ON PLASMODIUM BERGHEI IN NATURE AND UNDER EXPERIMENTAL CONDITIONS. Trans R Soc Trop Med Hyg. 1965 May;59:255-76.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 23, 2015): 1500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2025
• Estimated Primary Completion Date: September 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

• INCLUSION CRITERIA:

All of the following criteria must be fulfilled for a subject to participate in this trial:

1. Age greater than or equal to 18 and less than or equal to 50 years.
2. In good general health and without clinically significant medical history
3. Reliable access to the clinical trial center and available in the area for more than 1 year
4. Females of childbearing potential must be willing to undergo periodic pregnancy testing and use reliable contraception per protocol when enrolled into LMIV clinical trials (protocol-specific requirements)

EXCLUSION CRITERIA:

A subject will be excluded from participating in this trial if any one of the following criteria is

fulfilled:

1. Pregnant, breastfeeding, or planned pregnancy in the upcoming year.
2. Hemoglobin, white blood cell (WBC), platelets, alanine transaminase (ALT), and creatinine (Cr) outside of local lab normal range (subjects may be included at the investigator s discretion for not clinically significant values outside of normal range).
3. Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin. Subject can be included if investigator determine the abnormality is not clinically significant.

4. Anticipated use during the study period, or use within the following periods prior to enrollment:

   1. Investigational malaria vaccine within the last five years
   2. Chronic systemic immunosuppressive medications (e.g., cytotoxic medications, oral/parental corticosteroids > 0.5 mg/kg/day prednisone or equivalent). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are allowed.
   3. Recurrent receipt of blood products or immunoglobulins

5. History of:

   1. Sickle cell disease
   2. Splenectomy or functional asplenia
   3. Systemic anaphylaxis
   4. Uncontrolled psoriasis or porphyria

6. Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status and participation in the study in the opinion of the Investigator. A clinically significant condition or process includes but is not limited to:

   1. A process that would affect the immune response, or requires medication that

      affects the immune response.

   2. Any contraindication to repeated phlebotomy.

7. History of or known active cardiac disease including:

   1. prior myocardial infarction (heart attack)
   2. angina pectoris
   3. congestive heart failure
   4. valvular heart disease
   5. cardiomyopathy
   6. pericarditis
   7. stroke or transient ischemic attack
   8. exertional chest pain or shortness of breath
   9. other heart conditions under the care of a doctor
8. Infection with HIV, hepatitis B, and/or hepatitis C

9. Psychiatric condition that precludes compliance with the protocol including but not limited

   to:

   1. Psychosis within the past 3 years
   2. Ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
10. Suspected or known current alcohol or drug abuse as defined by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at the discretion of the PI
11. Any other finding that, in the judgment of the Investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject s ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: David M Cook, M.D.; (240) 627-3066; cookdm@mail.nih.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02639299
• Other Study ID Numbers: 160039; 16-I-0039
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: .This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV).@@@@@@This screening protocol is designed to evaluate potential healthy volunteers to build a pool of volunteers who may participate in future and ongoing LMIV malaria drug, vaccine, or controlled human malaria infections (CHMI) trials. Data obtained for individual subjects will used not be used for direct research purposes on this study; therefore we will not make IPD available at this time.

• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
• Original Responsible Party: Same as current
• Current Study Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David M Cook, M.D.; National Institute of Allergy and Infectious Diseases (NIAID)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: October 15, 2021