Immune Response To Intranasal Influenza Vaccination

December 5, 2023 updated by: Rebecca Cox, University of Bergen

The Systemic And Local Immune Response To Intranasal Influenza Vaccination

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, N5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluenz vaccine
LAIV vaccine
Drug: FLUENZ
live attenuated influenza vaccine
Other Names:
  • FLUMIST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
31.12.2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

Investigators

  • Principal Investigator: Hans Jørgen Aarstad, Haukeland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimated)

May 31, 2013

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAIV-tonsilsv2 Version 2
  • 2012-002848-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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