MedTrace Logo

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

NCT00984451 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2019-08-19

No results posted yet for this study

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.

Conditions

  • Influenza A Virus Infection
  • Swine Flu

Interventions

BIOLOGICAL

Plasma collection following infection or vaccination with influenza A

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00984451 on ClinicalTrials.gov