Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639299
Recruitment Status : Recruiting
First Posted : December 24, 2015
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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.


Condition or disease
Malaria

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
Actual Study Start Date : December 8, 2016
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort
Healthy Volunteers
healthy, malaria-naive US adults



Primary Outcome Measures :
  1. To screen healthy volunteers for eligibility to enroll in studies to evaluate investigational antimalarial drugs, malaria vaccines, and/orundergo CHMI. [ Time Frame: One Year ]
    identify healthy adults at a low risk of developing complications due to experimental malaria infection, investigational antimalarials and vaccines



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers in the Washington, DC region
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639299


Contacts
Layout table for location contacts
Contact: David M Cook, M.D. (240) 627-3066 cookdm@mail.nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: David M Cook, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02639299    
Other Study ID Numbers: 160039
16-I-0039
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: January 22, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Subjects
Venipuncture
Research
Evaluate
Recruit
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases