Screening healthy volunteers for malaria vaccine and drug studies

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

This study is looking for healthy volunteers to see if they can join future research on malaria vaccines and treatments.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Drugs / interventions: prednisone
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT02639299 on ClinicalTrials.gov

What this trial studies

This study aims to recruit healthy volunteers to determine their eligibility for future research on malaria vaccines, antimalarial drugs, and controlled human malaria challenges. Participants will undergo a prescreening process followed by a detailed medical history assessment and physical examination. The goal is to build a pool of qualified volunteers for ongoing and future malaria-related clinical trials conducted by the Laboratory of Malaria Immunology and Vaccinology. This initiative addresses the urgent need for effective malaria prevention and treatment options.

Who should consider this trial

Good fit: Ideal candidates are healthy individuals aged 18 to 50 who meet specific health criteria.

Not a fit: Patients who are pregnant, breastfeeding, or have significant medical histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this could lead to the development of effective malaria vaccines and treatments, significantly reducing the disease's impact.

How similar studies have performed: Other studies have shown promise in developing malaria vaccines and treatments, making this approach a continuation of ongoing efforts in malaria research.

Eligibility criteria

* INCLUSION CRITERIA:

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

1. Age \>= 18 and \<= 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 is 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

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: David M Cook, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: David M Cook, M.D.

Conditions: Malaria, Subjects, Venipuncture, Research, Evaluate, Recruit