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A Pilot Study for Collection of Anti-Influenza A H1N1 (Swine Flu) Plasma

2014-08-27 03:19:04 | BioPortfolio

Summary

Background:

- The influenza virus can cause infections that lead to fever, cough, muscle aches, diarrhea, and headaches, and can even be fatal in some people. A new type of influenza, called novel H1N1 influenza (or swine flu), affects people of all ages and in some situations has been reported to have a higher rate of death than seasonal influenza.

- Currently, treatments are available for this influenza, 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 this virus.

Objectives:

- To collect plasma (the liquid component of blood containing antibodies) from people who have high levels of antibodies against the novel H1N1 influenza virus because they either have been previously infected with the virus or have been vaccinated against the infection.

Eligibility:

- Healthy individuals between 18 and 60 years of age who are eligible to donate blood.

- Individuals must have previously either recovered from novel H1N1 influenza or have been vaccinated against the infection, and may be subject to other restrictions on participating in National Institutes of Health research studies.

Design:

- Participants 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 3 sessions of apheresis; if willing, they can volunteer to participate in up to 10 sessions.

- After plasma is collected, it will be tested to ensure that it can be used to safely develop treatments for patients who have novel H1N1 flu.

Description

Influenza A/H1N1 (commonly referred to as "swine flu") is a novel influenza virus. Most people will not have immunity to it. As of November 15, 2009, worldwide more than 206 countries have reported laboratory confirmed cases of pandemic influenza H1N1 2009. As many countries have stopped counting individual cases, particularly of milder illness, the case count is likely to be significantly lower than the actual number of cases that have occurred. However, compilation statistics suggest that as of November 22, 2009, more than 3 million people worldwide have been infected with H1N1 with at least 8000 deaths attributed to the virus. Mortality likely remains significantly higher than seasonal influenza.

Circulating 2009 H1N1 isolates are highly resistant to amantadine and rimantadine. Additionally there is concern this virus may also acquire oseltamivir resistance that is seen in circulating seasonal H1N1 virus. Due to the limited therapeutic options for influenza and significant morbidity despite treatment, additional therapeutics for H1N1 are warranted. The objective of this protocol is collection anti-influenza A H1N1 immune plasma from human volunteers. This protocol does not administer any investigational product, but rather collects plasma from subjects with a high titer anti-influenza H1N1 2009 antibody titer (convalescent survivors of influenza A/H1N1 infection or recipients of the H1N1 vaccine).

Following screening of potential subjects to screen out those who are not eligible to participate in plasma donations and to determine there likelihood of having antibodies to influenza A/H1N1 20009 by recent infection or immunization, enrolled subjects will receive a baseline physical and laboratory examination. Eligible subjects with high influenza A/H1N1 2009 hemagglutination inhibition (HAI) titers will then be scheduled for three (and up to ten) plasma collection sessions. Following testing of the collected plasma for potential pathogens, it may be used as a therapeutic plasma, and/or it may be used for the manufacturing of high titer anti-H1N1 intravenous immune globulin (IVIG). Both options would support clinical trials aimed at developing additional therapeutics for H1N1 infection.

Study Design

N/A

Conditions

H1N1 Influenza

Location

The Johns Hopkins Medical Institutions
Baltimore
Maryland
United States
21287

Status

Recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:04-0400

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Medical and Biotech [MESH] Definitions

A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 1. The H1N1 subtype was responsible for the Spanish flu pandemic of 1918.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

A genus of the family ORTHOMYXOVIRIDAE comprising viruses similar to types A and B but less common, more stable, more homogeneous, and lacking the neuraminidase protein. They have not been associated with epidemics but may cause mild influenza. Influenza C virus is the type species.

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