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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 23, 2015

Keywords

ClinConnect Summary

This clinical trial is focused on finding safe and effective treatments for malaria, a serious disease caused by a parasite that can be transmitted through mosquito bites. Researchers at the National Institutes of Health (NIH) are looking for healthy volunteers to help them test new malaria vaccines, drugs, and prevention methods. If you are between 18 and 50 years old and in good health, you may be eligible to participate. The screening process involves a phone interview followed by a medical history review, physical exam, and some blood and urine tests.

As a participant, you could help advance important research, but you should know that if you join, you may not start a trial right away and could be contacted again later if you still want to participate. It's also important to note that certain health conditions, like being pregnant or having specific medical histories, may prevent you from taking part in this study. If you're interested in contributing to the fight against malaria, this could be a great opportunity!

Gender

ALL

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. 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