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

NCT02639299 | Recruiting

• 2 other identifiers: 16003916-I-0039
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Subjects; Venipuncture; Research; Evaluate; Recruit

Outcome Measures

Primary Outcomes (1)

• To screen healthy volunteers for future malaria studies

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

  1 year

Study Arms (1)

Healthy volunteer

healthy, malaria-na(SqrRoot) ve US adults

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers in the Washington, DC region

You may qualify if:

• All of the following criteria must be fulfilled for a subject to participate in this trial:
• Age \>= 18 and \<= 50 years.
• In good general health and without clinically significant medical history
• Reliable access to the clinical trial center and available in the area for more than 1 year
• 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)

You may not qualify if:

• A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
• Pregnant, breastfeeding, or planned pregnancy in the upcoming year.
• 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).
• Anticipated use during the study period, or use within the following periods prior to enrollment:
• Investigational malaria vaccine within the last five years
• 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.
• Recurrent receipt of blood products or immunoglobulins
• History of:
• Sickle cell disease
• Splenectomy or functional asplenia
• Systemic anaphylaxis
• Uncontrolled psoriasis or porphyria
• 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:
• A process that would affect the immune response, or requires medication that affects the immune response.
• Any contraindication to repeated phlebotomy.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• YOELI M. STUDIES ON PLASMODIUM BERGHEI IN NATURE AND UNDER EXPERIMENTAL CONDITIONS. Trans R Soc Trop Med Hyg. 1965 May;59:255-76. doi: 10.1016/0035-9203(65)90004-0. No abstract available.

  PMID: 14298028 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• David M Cook, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Cook, M.D.

CONTACT

(240) 627-3066; cookdm@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 24, 2015
• Study Start: December 8, 2016
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: June 8, 2026

Record last verified: 2025-12-30

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)