Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
Overview
- Phase
- Not Applicable
- Intervention
- Healthy volunteer
- Conditions
- Malaria
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- To screen healthy volunteers for future malaria studies
- Status
- Recruiting
- Last Updated
- 8 days ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •INCLUSION CRITERIA:
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Healthy volunteer
healthy, malaria-na(SqrRoot) ve US adults
Outcomes
Primary Outcomes
To screen healthy volunteers for future malaria studies
Time Frame: 1 year
identify healthy adults at a low risk of developing complications due to experimental malaria infection, investigational antimalarials and vaccines