A Pilot Study for Collection of Anti-Influenza A Immune Plasma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00984451|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2009
Last Update Posted : December 18, 2017
- 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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment|
|Influenza A Virus Infection Swine Flu||Biological: Plasma collection following infection or vaccination with influenza A|
Two types of influenza A widely circulate in humans and cause seasonal outbreaks and epidemics - H1N1 (swine flu) and H3N2 (a subtype abundant in seasonal influenza). During the 2009-2010 influenza season, the most commonly reported virus was influenza A (H1N1). However, during the 2010-2011 influenza season, the most commonly reported virus was influenza A (H3N2), but influenza A (H1N1) viruses and influenza B viruses circulated as well.
A certain age group may be hit harder by one type of influenza virus than another (for example, the 2009 H1N1 virus disproportionately affected people younger than 65 years of age rather than those older than 65, whereas H3N2 virus often affects those older than 65 years). However, influenza A has a substantial health effect on every age group.
Due to the limited therapeutic options for influenza and significant morbidity and mortality despite treatment, additional therapeutics are warranted. One potential therapeutic that is fairly rapidly available is the use of anti-influenza A immune plasma as immunotherapy.
The objective of this protocol is collection of anti-influenza A immune plasma from male volunteers that meet criteria for use in human plasma therapy studies. The use of plasma from male donors will minimize the risk of transfusion related acute lung injury (TRALI), which has been associated with antibodies (likely generated during pregnancy) found in female plasma. For this reason, only male donors will be enrolled.
This protocol does not administer any investigational product, but rather collects plasma from subjects with a high anti-influenza A antibody titer (convalescent survivors of influenza infection or recipients of a licensed influenza vaccine).
Following screening of potential subjects to identify those who are not eligible to participate in plasma donations and to determine the likelihood of having antibodies to influenza A (H1N1 or H3N2) from a recent infection or immunization, enrolled subjects will receive a baseline physical and laboratory examination. Eligible subjects with high influenza A hemagglutination inhibition (HAI) titers will then be scheduled for at least 3 (and up to 20) plasma collection sessions. Following testing of the collected plasma for potential pathogens, it may be used as therapeutic plasma, and/or it may be used for the manufacturing of high titer anti-influenza A intravenous immune globulin (IVIG). Both options would support clinical trials aimed at developing additional therapeutics for influenza infection.
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||A Pilot Study for Collection of Anti-Influenza A Immune Plasma|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Biological: Plasma collection following infection or vaccination with influenza A
- Collection of Anti-Influenza A Immune Plasma [ Time Frame: Individual duration is a maximum of 240 days per subject. ]Subjects will be scheduled for at least 3, and up to 20, plasma collection procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984451
|United States, California|
|UCLA Care Center|
|Los Angeles, California, United States, 90095|
|UCLA Pediatric Infectious Diseases|
|Los Angeles, California, United States, 90095|
|United States, Colorado|
|University of Colorado Hospital Blood Donor Center|
|Aurora, Colorado, United States, 80045|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, New York|
|AIDS Clinical Trials Unit, NYU School of Medicine|
|New York, New York, United States, 10016|
|Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Clinical Translational Research Center (CTRC) at UNC Hospitals|
|Chapel Hill, North Carolina, United States, 27599-7600|
|United States, Ohio|
|AIDS Clinical Trial Unit, Holmes Hospital, Div of Infectious Disease, University of Cincinnati College of Medicine|
|Cincinnati, Ohio, United States, 45267|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104|