Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00984451
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2009-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study for Collection of Anti-Influenza A Immune Plasma
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Pilot Study for Collection of Anti-Influenza A Immune Plasma
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: