RECRUITING

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

Conditions

Malaria Subjects Venipuncture Research Evaluate Recruit

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

Official Title

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

Quick Facts

Study Start:2016-12-08

Study Completion:2030-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02639299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
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)	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. 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 4. History of: 1. Sickle cell disease 2. Splenectomy or functional asplenia 3. Systemic anaphylaxis 4. Uncontrolled psoriasis or porphyria 5. 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. 6. 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 7. Infection with HIV, hepatitis B, and/or hepatitis C 8. 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 9. 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 10. 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

Inclusion Criteria

Exclusion Criteria

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)

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. 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
4. History of:
1. Sickle cell disease
2. Splenectomy or functional asplenia
3. Systemic anaphylaxis
4. Uncontrolled psoriasis or porphyria
5. 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.
6. 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
7. Infection with HIV, hepatitis B, and/or hepatitis C
8. 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
9. 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
10. 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

Contacts and Locations

Study Contact

David M Cook, M.D.

CONTACT

(240) 627-3066

cookdm@mail.nih.gov

Principal Investigator

David M Cook, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

David M Cook, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-08

Study Completion Date2030-09-30

Study Record Updates

Study Start Date2016-12-08

Study Completion Date2030-09-30

Terms related to this study

Keywords Provided by Researchers

Subjects
Venipuncture
Research
Evaluate
Recruit

Additional Relevant MeSH Terms

Malaria