Malaria Clinical Trials Center General Screening

NCT02119312 | Completed

• 1 other identifier: MC-002
• Study Type: observational
• Target: 2,101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

Malaria; Plasmodium; Plasmodium falciparum; Clinical Trials; Vaccine Study; Drug Study; Malaria Clinical Trials Center; Seattle BioMed; Center for Infectious Disease Research

Outcome Measures

Primary Outcomes (1)

• Participant Enrollment

  See inclusion/exclusion criteria.

  Once upon enrollment

Eligibility Criteria

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

Study Population

Men and non-pregnant women who are in general good health.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Links

• Seattle Malaria Clinical Trials Center

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Study Officials

• James G Kublin, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: June 1, 2010
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

US (1)