Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2101 participants
OBSERVATIONAL
2010-06-30
2020-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
NCT02639299
Malaria Challenge in Healthy Volunteers
NCT01500980
Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines
NCT00443131
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
NCT00312702
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
NCT00312663
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fred Hutchinson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James G Kublin, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Seattle Malaria Clinical Trials Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MC-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.