Apheresis to Obtain Plasma and White Blood Cells in Malies

NCT01511601 | Withdrawn

• 2 other identifiers: 99991204812-I-N048
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: \- Some clinical trials require larger amounts of plasma and white blood cells than can be collected through simple blood donations. Apheresis is a procedure used to collect parts of the blood for study and return the rest of the blood to the donor. Healthy volunteers who provide plasma and white blood cells for study may need to give multiple donations. Researchers want to use apheresis to collect plasma and white blood cells from healthy volunteers in Mali. Objectives: \- To collect plasma and white blood cells from healthy volunteers in Mali. Eligibility:

• Healthy volunteers between 18 and 55 years of age.
• Volunteers must be in National Institute of Allergy and Infectious Diseases clinical trials. Design:
• Participants will be screened with a physical exam and medical history. They will also provide basic blood and urine samples.
• Participants will have apheresis to collect plasma and white blood cells for study. Before each collection, they will provide a small blood sample for testing. They will be monitored during and after donation to prevent side effects.
• Under this protocol, participants may have apheresis up to six times per year.
• No treatment will be provided as part of this protocol....

Conditions

Malaria

Keywords

Apheresis; Leukocytes; Plasma; Plamodium Falciparum Malaria; Immunology

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals 18-55 years of age are eligible to enter the study if they:
• Are enrolled on another NIAID/FMPOS-approved protocol.
• Weigh greater than or equal to 50 kg.
• Agree to have blood specimens stored for future studies.
• Agree to undergo genetic testing.
• Agree to undergo HIV, hepatitis B, and hepatitis C virus testing.

You may not qualify if:

• Positive at screening for HIV, hepatitis B, and/or hepatitis C.
• Cardiovascular instability (blood pressure \<90/50 or \>180/100; pulse \<40 or \>110.
• Inadequate peripheral venous access.
• Anemia (hemoglobin \<11 g/dL).
• Current use of corticosteroids or other immunosuppressants.
• Underlying heart disease, lung disease, bleeding disorder, or other conditions that, in the judgment of the investigator, contraindicates apheresis.
• Temperature greater than or equal to 37.5 degree C or other clinical evidence of an acute infection.
• Currently pregnant or breastfeeding.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter D Crompton, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 18, 2012
• Study Start: December 20, 2011
• Study Completion: July 28, 2016
• Last Updated: December 16, 2019

Record last verified: 2016-07-28