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Blood and Plasma Collection For Use in Future Clinical Trials

This study is ongoing, but not recruiting participants.
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 13, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Influenza A Virus Infection
Biological: Collection of Anti-Influenza A 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 Plasma

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Further define the hemagglutination inhibition (HAI) immune response 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 Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Influenza A Exposure
Participants will include people who have recovered from influenza, received a seasonal influenza vaccine, or have both recovered from influenza and received a seasonal influenza vaccine.
Biological: Collection of Anti-Influenza A Immune Plasma

Detailed Description:

There is a concern that the influenza virus will become resistant to the standard of care, oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed in people infected with the seasonal influenza virus. Because of the possibility of drug resistance, additional treatment options for influenza are needed. The purpose of this study is to collect blood from people who have recovered from influenza or who have received 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 influenza.

This study will enroll people who have recovered from influenza or received a seasonal influenza 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:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will include people who have recovered from influenza, received a seasonal influenza vaccine, or have both recovered from influenza and received a seasonal influenza vaccine.

Criteria

Inclusion Criteria:

  • Currently healthy males 18 - 59 years of age with a history suggestive of having anti-influenza antibodies (either or both of the following):

    1. An influenza-like illness (e.g., fever, chills, malaise, cough, myalgias, nausea). Subjects must asymptomatic and must be afebrile for ≥ 7 days, and must enroll within 12 months of onset of illness.
    2. Vaccinated with a licensed influenza vaccine. Enrollment must occur >14 days and < 12 months from date of vaccination.
  • Must be an adult male 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 and H3N2 HAI titer of 1:40 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136057

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Maryland
Naval Medical Research Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Investigators
Principal Investigator: LCDR Nicholas Martin, USN, MSC 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 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014