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Blood and Plasma Collection For Use in Future H1N1 (Swine Flu) Clinical Trials

This study is currently recruiting participants.
Verified December 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01136057
First received: May 14, 2010
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

Treatment options are limited for the new strain of the H1N1 influenza virus, which differs from the seasonal H1N1 influenza virus. This study will collect blood from people who have been exposed to the H1N1 virus or who have received the H1N1 or seasonal influenza vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with H1N1 influenza.


Condition Intervention
Influenza A Subtype H5N1 Infection
 Biological: Collection of Anti-Influenza A/H1N1 Immune Plasma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study for Collection of High-Titer Anti-Influenza A H1N1 (Swine Flu) Plasma

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Collection of high antibody titer anti-influenza H1N1 FFP [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Further define the hemagglutination inhibition (HAI) immune response to swine H1N1 (infection and/or vaccine) in participants over time [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood will be collected from participants.


Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
H1N1 Exposure
Participants will include people who have recovered from H1N1 influenza, received the H1N1 vaccine or seasonal influenza vaccine after July 2010, or have both recovered from H1N1 influenza and received the H1N1 vaccine.
 Biological: Collection of Anti-Influenza A/H1N1 Immune Plasma

Detailed Description:

Swine origin influenza virus (A/H1N1), commonly referred to as "swine flu," is a new influenza virus, which differs from the seasonal H1N1 influenza virus. Most people will not have immunity to this new H1N1 virus strain. There is a concern that this virus will become resistant to oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed in people with the seasonal H1N1 influenza virus. Because of the possibility of drug resistance, additional treatment options for the H1N1 virus are needed. The purpose of this study is to collect blood from people who have been exposed to the H1N1 virus or who have received the H1N1 vaccine or a seasonal influenza vaccine. The blood will then be processed into Food and Drug Administration (FDA)-licensed fresh frozen plasma (FFP). In a future clinical trial, this plasma will be used as a treatment for people hospitalized with H1N1 influenza.

This study will enroll people who have recovered from H1N1 influenza, received the H1N1 vaccine or seasonal influenza vaccine after July 2010, or have both recovered from H1N1 influenza and received the H1N1 vaccine. Participants will donate blood at FDA-licensed blood donor centers up to three times during the 240-day study period.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will include people who have recovered from H1N1 influenza, received the H1N1 vaccine or seasonal influenza vaccine after July 2010, or have both recovered from H1N1 influenza and received the H1N1 vaccine.

Criteria

Inclusion Criteria:

  • Currently healthy individuals with a history suggestive of having anti-influenza H1N1 antibodies (either or both of the following):

    1. An influenza-like illness (e.g., fever, chills, malaise, cough, myalgias, nausea) consistent with novel H1N1 influenza or otherwise having met the Centers of Disease Control definitions for a suspected, probable, or confirmed case of H1N1. Participants must be at least 7 days past the resolution of fever and enroll within 12 months of illness.
    2. Vaccinated with a licensed or investigational novel H1N1 vaccine or seasonal influenza vaccine after July 2010; must be at least 14 days since the last vaccination and within 12 months of the last vaccination.
  • Must be Department of Defense (DoD)/beneficiary
  • Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) document
  • A demonstrated H1N1 HAI titer of 1:160 or greater
  • Must also meet all Standard-of-Care inclusion criteria for donation of blood or plasma at the FDA-licensed donor center prior to every donation session. More information on this criterion can be found in the protocol.

Exclusion Criteria:

  • Donors that do not meet all Standard-of-Care FDA approved requirements for the donation of blood and production of FFP as determined by the FDA-licensed donor center prior to every donation session may be excluded from further participation in this study. Study exclusion will be determined by the principal investigator (PI) or lead investigator at the study site.

  • Donors that fail the Standard-of-Care screening and Blood Borne Pathogen screening for the following blood borne pathogens at the donor center will be excluded:

    1. Anti-HIV-I/II
    2. Anti-human T-lymphotropic virus (HTLV)-I/II
    3. Anti-hepatitis C (HCV)
    4. Anti-hepatitis B core antigen (HBc)
    5. Anti-T. cruzi (enzyme immunoassay [EIA] for Chagas disease) (if required by the FDA-licensed donor center or becomes a nationwide FDA requirement)
    6. Hepatitis B surface antigen (HBsAg)
    7. Serologic test for syphilis
    8. HIV nucleic acid test (NAT)
    9. HCV NAT
    10. West Nile virus (WNV) NAT

  • Participation in other medical research that includes:

    1. Studies that are currently ongoing or will start during the duration of this study that require more than 60 mL of blood to be donated in any 56-day period of time
    2. Administration of any unlicensed drug in the 3 months before study entry or during the duration of this study
    3. Administration of any unlicensed vaccine in the 12 months before study entry or during the duration of this study, with the exception of unlicensed influenza vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136057

Locations
United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: CAPT Mary Bavaro, MC, USN     619-532-7475        
United States, Maryland
Naval Medical Research Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Thomas C. Luke, MD     301-295-0275     Thomas.Luke@med.navy.mil    
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: LCDR Janine Danko, MC, USN, MD, MPH, FACP Virology and Rickettsial Diseases Department, Naval Medical Research Center
  More Information

Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01136057     History of Changes
Other Study ID Numbers: IDCRP-046
Study First Received: May 14, 2010
Last Updated: December 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013