Immune Response To Intranasal Influenza Vaccination

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen
ClinicalTrials.gov Identifier:
NCT01866540
First received: October 22, 2012
Last updated: February 16, 2014
Last verified: February 2014
  Purpose

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 Intervention
Tonsillitis, Hypertrophy
Drug: FLUENZ

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Systemic And Local Immune Response To Intranasal Influenza Vaccination

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • evaluation of the systemic and local immune response after live attenuated influenza vaccine. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measurement of systemic and local immune responses in immunological assays


Other Outcome Measures:
  • Influenza specific responses [ Time Frame: 31.12.2015 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
ENT patients scheduled for operation
Drug: FLUENZ
live attenuated influenza vaccine
Other Name: FLUMIST

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.

  Eligibility

Ages Eligible for Study:   2 Years to 59 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: October 22, 2012
Last Updated: February 16, 2014
Health Authority: Norway: Norwegian Medicines Agency

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

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

ClinicalTrials.gov processed this record on September 11, 2014