Status:
COMPLETED
Blood and Plasma Collection For Use in Future Clinical Trials
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza A Virus Infection
Eligibility:
MALE
18-59 years
Brief Summary
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. ...
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 infecte...
Eligibility Criteria
Inclusion
- Currently healthy males 18 - 59 years of age with a history suggestive of having anti-influenza antibodies (either or both of the following):
- 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.
- 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
- 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:
- Anti-HIV-I/II
- Anti-human T-lymphotropic virus (HTLV)-I/II
- Anti-hepatitis C (HCV)
- Anti-hepatitis B core antigen (HBc)
- Anti-T. cruzi (enzyme immunoassay \[EIA\] for Chagas disease) (if required by the FDA-licensed donor center or becomes a nationwide FDA requirement)
- Hepatitis B surface antigen (HBsAg)
- Serologic test for syphilis
- HIV nucleic acid test (NAT)
- HCV NAT
- West Nile virus (WNV) NAT
- Participation in other medical research that includes:
- 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
- Administration of any unlicensed drug in the 3 months before study entry or during the duration of this study
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 4 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01136057
Start Date
April 1 2010
End Date
January 4 2019
Last Update
March 13 2019
Active Locations (2)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134
2
Naval Medical Research Center
Bethesda, Maryland, United States, 20889