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Completed

NCT Number: NCT01987349

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009

This study will compare influenza vaccine responses in monozygotic and dizygotic twins.

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Key information

Age range

8 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

The investigators plan to study the response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twin pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or fraternal twin pairs) or 70-100 years (twin or 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 and vital signs.
  • Negative urine pregnancy test for women of childbearing potential
  • If the subject is female and of childbearing potential, she must use an acceptable method of contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

Exclusion criteria

  • Prior vaccination with 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 (LAIV groups only)
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  • History of immune deficiency
  • 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, blood pressure >150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  • Hospitalization in the past year for congestive heart failure or emphysema.
  • Chronic Hepatitis B or C
  • Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
  • Subjects 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, Plavix, Aggrenox may be acceptable after review by investigator.
  • Receipt of blood or blood products within the past 6 months
  • Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
  • Inactivated vaccine 14 days prior to vaccination
  • Live, attenuated vaccine within 60 days of vaccination
  • History of Guillain-Barre 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.

Treatment and study plan

Fluzone® (intramuscular)

Biological

Licensed seasonal trivalent inactivated influenza vaccine (IIV3)

FluMist® (intranasal)

Biological

Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)

Primary outcomes

  1. Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine

    Time frame: Day 0 to 28

Secondary outcomes

  1. Number of Participants With Related Adverse Events

    Time frame: Day 0 to 28 post-immunization

Other outcomes

  1. Lymphocyte Response to Influenza Immunization

    Time frame: Day 6-28 post-immunization

    Compare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Protective Mechanisms Against a Pandemic Respiratory Virus: B- Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 1, 2009

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2013
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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