NCT02119312

Completed

Malaria Clinical Trials Center General Screening

Fred Hutchinson Cancer Center Source

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Other study identifiers

Sponsor study identifier

MC-002

Study Type

observational

Actual enrollment (reported)

2,101

Locations

1 country

Sites

1

Timeline

Study Start

June 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 1, 2020

Actual (reported)

Study Completion

September 1, 2020

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 2,101 participants
Study completion date: September 1, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
April 16, 2014
Actual (reported)
First Posted
April 21, 2014
Actual (reported)
Primary Completion
September 1, 2020
Actual (reported)
Study Completion
September 1, 2020
Actual (reported)

Last Updated: September 14, 2020
Status Verified: September 2020
Last Update Submitted: September 10, 2020

Conditions

Malaria

Keywords

MalariaPlasmodiumPlasmodium falciparumClinical TrialsVaccine StudyDrug StudyMalaria Clinical Trials CenterSeattle BioMedCenter for Infectious Disease Research

Outcome Measures

Primary Outcomes (1)

Participant Enrollment
See inclusion/exclusion criteria.
Once upon enrollment

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodProbability 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;

Sponsors & Collaborators

Fred Hutchinson Cancer Center
Otherlead

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

James G Kublin, MD
Fred Hutchinson Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

2,101 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1/2Completed

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Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults

Phase 1Completed

NCT01024686

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Phase 1/2Terminated

NCT01434381

Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)

Phase 1Completed

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.

Contact the study team to confirm eligibility.

Primary Completion

September 1, 2020

Actual (reported)

Study Completion

September 1, 2020

Actual (reported)

Last Updated

September 14, 2020

Record last verified: 2020-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02119312
Data provider: ClinicalTrials.gov
Source updated: 2020-09-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:53 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations