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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

May 14, 2010
December 13, 2013
April 2010
April 2015   (final data collection date for primary outcome measure)
Collection of high antibody titer anti-influenza FFP [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]
Collection of high antibody titer anti-influenza H1N1 FFP [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01136057 on ClinicalTrials.gov Archive Site
Further define the hemagglutination inhibition (HAI) immune response in participants over time [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Blood and Plasma Collection For Use in Future Clinical Trials
A Pilot Study for Collection of High-Titer Anti-Influenza A Plasma

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood will be collected from participants.

Non-Probability Sample

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.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Male
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01136057
IDCRP-046
No
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: LCDR Nicholas Martin, USN, MSC Virology and Rickettsial Diseases Department, Naval Medical Research Center
National Institute of Allergy and Infectious Diseases (NIAID)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP