A Pilot Study for Collection of Anti-Influenza A Immune Plasma

Completed

Conditions studied: Influenza A Virus Infection, Swine Flu

In brief

Background: * The influenza A virus can cause infections that lead to fever, cough, muscle aches, diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills an estimated 36,000 people in the United States each year. In addition, more than 200,000 people are hospitalized for flu-related complications. Influenza A has a substantial health effect on every age group. * Currently, treatments are available for influenza A, but there is concern that the rate of complications or even death from this infection is still high despite treatment, and that over time this virus may become resistant to these treatments. Researchers are interested in developing a possible new treatment that uses antibodies against influenza A virus. Objectives: \- To collect plasma (the liquid component of blood containing antibodies) from people who have high levels of antibodies against the influenza A virus because they either have been previously infected with the virus or have been vaccinated against the infection. Eligibility: * Healthy male volunteers between 18 and 60 years of age who are eligible to donate blood. * Individuals must have previously either recovered from influenza infection or have been vaccinated against the infection, and may be subject to other restrictions on participating in National Institutes of Health research studies. Design: * Volunteers will undergo apheresis, an outpatient procedure in which researchers will collect plasma containing antibodies against the influenza virus by drawing blood into a special machine that separates blood cells from the liquid portion under sterile conditions and then returns the blood cells to the donor. * Volunteers will be screened with blood tests to ensure that they are eligible to participate and donate blood. * Volunteers are asked to undergo at least 3 sessions of apheresis; if willing, they can volunteer to participate in up to 20 sessions. * After plasma is collected, it will be tested to ensure that it can be used to safely develop treatments for patients who have influenza A infection.

Key facts

Study ID

NCT00984451

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

102

Starts

2009-09-01

Expected to finish

2018-12-01

Last updated by the study team

2019-08-19

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may not qualify if…

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• Any sign of active influenza, (as judged by the investigator) including but not limited to:
• Subjective or documented fever (> 38 Degrees C)
• Cough
• Shortness of breath
• Diarrhea
• Has a medical history of
• Thrombocytopenia or other blood dyscrasias
• Congestive heart failure
• Pulmonary hypertension
• Bleeding diathesis or therapeutic anticoagulation
• Human immunodeficiency virus (HIV)/AIDS
• Hepatitis B
• Hepatitis C
• Known history of hepatitis after the 11th birthday
• Trypanosomiasis (Chagas' disease and sleeping sickness)
• Leishmaniasis (Kala-azar)
• Filariasis
• Q fever
• Yaws
• History of cancer that meets any one of the following criteria:
• Leukemia or lymphoma: permanent deferral
• Melanoma: 10 year deferral (with exception of melanoma-in-situ: defer until biopsy site is healed)
• Squamous cell or basal cell cancer of skin: defer until excision site is healed
• All other cancers: defer for 2 years since end of treatment

Where it is running

• UCLA Care Center — Los Angeles, California, United States
• UCLA Pediatric Infectious Diseases — Los Angeles, California, United States
• University of Colorado Hospital Blood Donor Center — Aurora, Colorado, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• AIDS Clinical Trials Unit, NYU School of Medicine — New York, New York, United States
• Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College — New York, New York, United States
• Clinical Translational Research Center (CTRC) at UNC Hospitals — Chapel Hill, North Carolina, United States
• AIDS Clinical Trial Unit, Holmes Hospital, Div of Infectious Disease, University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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