CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
Plasma collection following infection or vaccination with influenza Abiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00984451
NCT00984451N/ACompleted

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

National Institute of Allergy and Infectious Diseases (NIAID)·observational·Posted Sep 25, 2009·Updated Aug 19, 2019

In Brief

An observational study evaluating Plasma collection following infection or vaccination with influenza A for Influenza A Virus Infection and Swine Flu. Completed, enrolled 102 participants across 12 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 16.8 years ago

Interventions

Plasma collection following infection or vaccination with influenza Abiological

High titer influenza A plasma collection for use as therapeutic plasma in influenza treatment studies.