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Immune Response To Intranasal Influenza Vaccination

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ClinicalTrials.gov Identifier: NCT01866540
Recruitment Status : Enrolling by invitation
First Posted : May 31, 2013
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen

Brief Summary:
This research during the last decade has focused on the kinetics of the systemic and local immune response to parenteral influenza vaccine in humans. The investigators have shown that normally high numbers of influenza specific antibody secreting cells (ASC) are present in the nasal mucosa of healthy adults but upon parenteral vaccination the numbers remain stable. However, a rapid transient increase in specific ASC is observed in the tonsils and peripheral blood after parenteral vaccination. In the tonsils, this is associated with a significant decrease in both naïve/effector (CD45RA+) and memory (CD45RO+) CD4+ cells upon vaccination. In this study the investigators will extend our work to investigate the characteristics of influenza-specific T- and B-cells induced locally and systemically after intranasal vaccination in man.

Condition or disease Intervention/treatment Phase
Tonsillitis, Hypertrophy Drug: FLUENZ Not Applicable

Detailed Description:
The clinical trial will be an open study. All subjects eligible for tonsillectomy at Haukeland University Hospital within the specified age range (children: 2 to less than 18 years old and adults >18-59 years old) will receive an invitation to join the study. The primary endpoints of the trial are the evaluation of the systemic and local immune response after live attenuated influenza vaccine. The vaccine specific immune response will be assessed through the induction of specific local and systemic antibody and cellular immune responses, and analyses of the epitopes to which the response is directed. Furthermore the capacity of the vaccine to elicit cross reactive and long lasting immunity will be evaluated.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Systemic And Local Immune Response To Intranasal Influenza Vaccination
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fluenz vaccine
LAIV vaccine
Drug: FLUENZ
live attenuated influenza vaccine
Other Name: FLUMIST



Primary Outcome Measures :
  1. evaluation of the systemic and local immune response after live attenuated influenza vaccine. [ Time Frame: 1 year ]
    Measurement of systemic and local immune responses in immunological assays


Other Outcome Measures:
  1. Influenza specific responses [ Time Frame: 31.12.2015 ]
    induction of specific local and systemic antibody and cellular immune responses, and analyses of the epitopes to which the response is directed. Furthermore the capacity of the vaccine to elicit cross reactive and long lasting immunity will be evaluated



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Ages Eligible for Study:   2 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children (age range ≥2 and <18 years old) or adults (>18-59 years old) as concluded from the medical history, physical examination, and clinical judgment) scheduled for tonsillectomy ;
  • Signed informed consent from the subject or both parents/ both guardians and from subjects aged 12 years and older;
  • Subjects or guardians able to understand and comply with the study protocol and complete the Adverse Event Form:
  • Subjects able to attend the scheduled visits.

Exclusion Criteria:

  • Persons with a history of anaphylaxis or serious reactions to any vaccine;
  • Person with known hypersensitivity to any of the vaccine components (e.g. gelatin, gentamicin, eggs or egg proteins (e.g. ovalbumin);
  • Persons who are pregnant
  • Persons who have had a temperature >38oC during the previous 72 hours;
  • Persons who have had an acute respiratory infection during the last 7 days;
  • Persons who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids;
  • Persons with severely immunocompromised family members;
  • Persons with severe asthma or active wheezing.

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): NCT01866540


Locations
Norway
Haukeland University Hospital
Bergen, Norway, N5021
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
Principal Investigator: Hans Jørgen Aarstad Haukeland University Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rebecca Cox, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT01866540     History of Changes
Other Study ID Numbers: LAIV-tonsilsv2 Version 2
2012-002848-24 ( EudraCT Number )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Rebecca Cox, University of Bergen:
influenza, LAIV, immune response

Additional relevant MeSH terms:
Influenza, Human
Hypertrophy
Tonsillitis
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases