Blood and Plasma Collection For Use in Future Clinical Trials

NCT01136057 | Completed

• 1 other identifier: IDCRP-046
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 2

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. The blood plasma will be used in a future clinical trial to treat people hospitalized with influenza.

Conditions

Influenza A Virus Infection

Outcome Measures

Primary Outcomes (1)

• Collection of high antibody titer anti-influenza FFP

  Collected at each study visit

Secondary Outcomes (1)

• Further define the hemagglutination inhibition (HAI) immune response in participants over time

  Collected at each study visit

Study Arms (1)

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

Interventions

Collection of Anti-Influenza A Immune Plasma BIOLOGICAL

Influenza A Exposure

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Naval Medical Research Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (2)

• Kash JC, Qi L, Dugan VG, Jagger BW, Hrabal RJ, Memoli MJ, Morens DM, Taubenberger JK. Prior infection with classical swine H1N1 influenza viruses is associated with protective immunity to the 2009 pandemic H1N1 virus. Influenza Other Respir Viruses. 2010 May 1;4(3):121-7. doi: 10.1111/j.1750-2659.2010.00132.x.

  PMID: 20409208 BACKGROUND

• Tang JW, Shetty N, Lam TT. Features of the new pandemic influenza A/H1N1/2009 virus: virology, epidemiology, clinical and public health aspects. Curr Opin Pulm Med. 2010 May;16(3):235-41. doi: 10.1097/MCP.0b013e3283375727.

  PMID: 20375785 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be collected from participants.

Study Officials

• LCDR Nicholas Martin, USN, MSC

  Virology and Rickettsial Diseases Department, Naval Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: June 3, 2010
• Study Start: April 1, 2010
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (2)