Malaria Clinical Trials Center General Screening



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:2/2/2019
Start Date:June 2010
Contact:Kelly Shipman
Email:malariatrials@fredhutch.org
Phone:(206) 667-3468

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General Screening for Eligibility to Participate in Treatment, Prevention and Vaccine Trials at the Seattle Malaria Clinical Trials Center

The purpose of this study is to identify and screen potential subjects for preliminary
eligibility to participate in a malaria related clinical trial conducted at the Seattle
Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.

This is a continuous study enrolling approximately 350 participants per year to establish
preliminary eligibility for participation in ongoing or future Seattle Malaria Clinical
Trials Center (Seattle MCTC) clinical research studies. Data collected may be used to support
preliminary eligibility for a current or future Seattle MCTC clinical research study.

In order to maximize efficiency of the screening process potential participants who contact
the site will be pre-screened using an IRB-approved screening form.

Potential participants who contact the site may be asked to come in for an in-person
screening visit. They will be given a consent form to read and sign if they should choose to
participate in the screening process. If they have any questions during this process research
staff will be available. This visit includes an in-depth medical history review, travel
history, physical exam, blood draw, electrocardiogram test (ECG), and a urine test.

The Seattle Malaria Clinical Trials Center (Seattle MCTC) is conducting research to combat
malaria. Malaria is a disease that is transmitted to humans by the bite of an infected
mosquito and affects millions of people worldwide. Malaria can cause a wide range of medical
problems, and may even result in death if the infection is not treated. Currently there are
many medications, preventative measures and malaria vaccines being developed to fight malaria
that will need to be tested before they can be made available to the general public. The
Seattle MCTC is conducting clinical research studies for this purpose and is in need of
healthy adult volunteers to take part in upcoming studies.

Inclusion Criteria:

- Good general health status as demonstrated by medical history, physical exam, and
screening laboratory tests;

- No history of certain chronic medical illnesses (e.g. diabetes, epilepsy, autoimmune
disease, hepatitis, heart disease);

- HIV, Hepatitis B and C negative;

- Low risk for coronary heart disease;

- Ability and willingness to provide informed consent;

- Reliable access to the MCTC and associated sites; and

- If participant is biologically female she must not be pregnant and must agree to
consistently use an effective form of birth control 21 days prior to enrollment in an
active clinical study and for the duration of that study.

Exclusion Criteria:

- Prior receipt of an investigational malaria vaccine;

- Chronic use of systemic antibiotics or immunosuppressive medications with
anti-malarial effects;

- Chronic 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;

- History of systemic anaphylaxis;

- History of, or known active cardiac disease;

- Elevated (moderate of high) risk of coronary heart disease;

- Clinically significant ECG findings;

- Chronic or active neurological disease;

- History of splenectomy or functional asplenia;

- History of psoriasis or porphyria;

- History of diagnosed ocular disease;

- Positive history of HIV, Hepatitis B and/or C;

- Pregnant or lactating females or females who intend to become pregnant during study
period;

- Certain psychiatric conditions that could affect study compliance; and

- Suspected or known current alcohol and/or drug abuse.
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Phone: 206-667-3468
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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from
Seattle, WA
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