A Pilot Study for Collection of Anti-Influenza A Immune Plasma
2 other identifiers
observational
102
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2009
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 19, 2019
August 1, 2019
9.3 years
September 24, 2009
August 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collection of Anti-Influenza A Immune Plasma
Subjects will be scheduled for at least 3, and up to 20, plasma collection procedures.
Individual duration is a maximum of 240 days per subject.
Interventions
High titer influenza A plasma collection for use as therapeutic plasma in influenza treatment studies.
Eligibility Criteria
Male subjects with a history consistent with influenza infection and/or vaccination against influenza.
You may qualify if:
- Provide written informed consent before initiation of any study procedures.
- Male adults between the ages of 18 and 60 years old
- History suggestive of having anti-influenza A antibodies (either of the following):
- An influenza like illness (e.g. fever, chills, malaise, cough, myalgias and nausea) consistent with influenza A infection. Subjects must not be symptomatic and be at least 7 days since the resolution of fever, and must enroll within 12 months of illness.
- Vaccination with a licensed influenza vaccine and at least 14 days following the last vaccination in the series, and enrolling within 12 months of vaccination.
- Some subjects may meet both requirements and enrollment should be within 12 months of the most recent event (illness or vaccination)
- Adequate clinical parameters (all of the following):
- Afebrile (temperature \< 38 Degrees C)
- Systolic blood pressure \> 100 and \< 180 mmHg
- Diastolic blood pressure \> 50 and \< 100 mmHg
- Heart rate between 50-100 beats/minute (Individual site blood establishment's SOPs may also permit healthy athletic subjects with heart rates \< 50 beats/minutes to donate plasma, and, if so, subjects with heart rates \< 50 beats/minutes may participate in this study)
- Weight greater than or equal to 110 pounds (50 kg)
- Adequate peripheral venous access for plasma donation (as judged by the examiner)
- Willingness to have samples stored
You may not qualify if:
- <!-- -->
- 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
- +82 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UCLA Care Center
Los Angeles, California, 90095, United States
UCLA Pediatric Infectious Diseases
Los Angeles, California, 90095, United States
University of Colorado Hospital Blood Donor Center
Aurora, Colorado, 80045, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
AIDS Clinical Trials Unit, NYU School of Medicine
New York, New York, 10016, United States
Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, 10065, United States
Clinical Translational Research Center (CTRC) at UNC Hospitals
Chapel Hill, North Carolina, 27599-7600, United States
AIDS Clinical Trial Unit, Holmes Hospital, Div of Infectious Disease, University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Washington
Seattle, Washington, 98104, United States
Related Publications (3)
Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
PMID: 8903148BACKGROUNDBean WJ, Schell M, Katz J, Kawaoka Y, Naeve C, Gorman O, Webster RG. Evolution of the H3 influenza virus hemagglutinin from human and nonhuman hosts. J Virol. 1992 Feb;66(2):1129-38. doi: 10.1128/JVI.66.2.1129-1138.1992.
PMID: 1731092BACKGROUNDde Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72. doi: 10.1056/NEJMoa054512.
PMID: 16371632BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 25, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
August 19, 2019
Record last verified: 2019-08