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B-cell Immunity to Influenza (SLVP017)- Year 1, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02133781
Recruitment Status : Completed
First Posted : May 8, 2014
Results First Posted : March 10, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Brief Summary:
This is an exploratory study using a strategy that has not been previously employed to investigate the effects of age and vaccine type on specific kinds of immune responses to licensed, seasonal 2009-2010 influenza vaccines in children and adults.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluzone® 2009-2010 Formula Biological: FluMist® 2009-2010 Formula Phase 4

Detailed Description:
This study is being conducted in healthy male and female volunteers. 8-17 year-old identical twins will be randomly assigned to receive a single administration of the 2009-2010 formulation of either seasonal trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). Twins within a pair will receive different vaccines. 18-30 year-old and 70-100 year-old subjects will receive a single administration of the 2009-2010 formulation of TIV. Blood samples to conduct the assays will be taken at pre-immunization, Day 7-8 and Day 28 post immunization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire- Year 1, 2009
Study Start Date : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Age 8-17 years (identical twins )
Participants will be randomized to receive either Fluzone® 2009-2010 Formula or FluMist® 2009-2010 Formula
Biological: Fluzone® 2009-2010 Formula
This vaccine is given intramuscularly
Other Names:
  • Trivalent inactivated influenza vaccine (TIV)
  • FDA-licensed seasonal influenza vaccine

Biological: FluMist® 2009-2010 Formula
This vaccine is given intranasally
Other Names:
  • Live, attenuated influenza vaccine (LAIV)
  • FDA-licensed seasonal influenza vaccine

Experimental: Age 18-30 years (non-twins)
Participants will be receive Fluzone® 2009-2010 Formula
Biological: Fluzone® 2009-2010 Formula
This vaccine is given intramuscularly
Other Names:
  • Trivalent inactivated influenza vaccine (TIV)
  • FDA-licensed seasonal influenza vaccine

Experimental: Age >70 years (non-twins)
Participants will receive Fluzone® 2009-2010 Formula
Biological: Fluzone® 2009-2010 Formula
This vaccine is given intramuscularly
Other Names:
  • Trivalent inactivated influenza vaccine (TIV)
  • FDA-licensed seasonal influenza vaccine




Primary Outcome Measures :
  1. Number of Participants From Each Arm Who Received Influenza Vaccine [ Time Frame: Day 0 to 28 ]

Secondary Outcome Measures :
  1. Number of Participants With Related Adverse Events [ Time Frame: Day 0 to 28 post-immunization ]

Other Outcome Measures:
  1. To Investigate the Effects of Age and Vaccine Type on B-cell Responses to Influenza Vaccine [ Time Frame: Day 0 to 28 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy, ambulatory children 8-17 year-old twins, adults 18-30 years old (non-twin) or 70-100 year-old elderly non-twin adults.
  • Willing to complete the informed consent process.
  • Availability for follow-up for the planned duration of the study at least 28 days after immunization.
  • Acceptable medical history by medical history and vital signs.

Exclusion Criteria:

  • Prior off-study vaccination with the current seasonal TIV or LAIV in Fall 2009
  • Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).
  • Life-threatening reactions to previous influenza vaccinations
  • Asthma or history of wheezing (for volunteers randomized to LAIV)
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  • History of immunodeficiency (including HIV infection)
  • Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • Blood pressure >150 systolic or >95 diastolic at first study visit
  • Hospitalization in the past year for congestive heart failure or emphysema.
  • Chronic Hepatitis B or C.
  • Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible except for non-LAIV Group only). Use of oral steroids (<20 mg prednisone-equivalent/day) may be acceptable for volunteers 70-100 yrs of age after review by the investigator.
  • Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV
  • Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
  • Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  • Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
  • Receipt of blood or blood products within the past 6 months
  • Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  • Inactivated vaccine 14 days prior to vaccination
  • Live, attenuated vaccine within 60 days of vaccination
  • History of Guillain-Barré Syndrome
  • Pregnant or lactating woman
  • Use of investigational agents within 30 days prior to enrollment
  • Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
  • Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133781


Locations
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United States, California
Stanford LPCH Vaccine Program
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Harry B Greenberg, MD Stanford University
Principal Investigator: Xiaosong He, PhD Stanford University

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT02133781    
Other Study ID Numbers: SU-17218- 2009
2U19AI057229-06 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2014    Key Record Dates
Results First Posted: March 10, 2017
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cornelia L. Dekker, Stanford University:
Inactivated influenza vaccine
Live, attenuated influenza vaccine
Child identical twins
Young and elderly adults
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs