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Immune Response To Intranasal Influenza Vaccination

Primary Purpose

Tonsillitis, Hypertrophy

Status

Unknown status

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

FLUENZ

About this trial

This is an interventional prevention trial for Tonsillitis, Hypertrophy focused on measuring influenza, LAIV, immune response

Eligibility Criteria

2 Years - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluenz vaccine

Arm Description

LAIV vaccine

Outcomes

Primary Outcome Measures

evaluation of the systemic and local immune response after live attenuated influenza vaccine.

Measurement of systemic and local immune responses in immunological assays

Secondary Outcome Measures

Full Information

NCT ID

NCT01866540

First Posted

October 22, 2012

Last Updated

August 1, 2021

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01866540

Brief Title

Immune Response To Intranasal Influenza Vaccination

Official Title

The Systemic And Local Immune Response To Intranasal Influenza Vaccination

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2012 (undefined)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tonsillitis, Hypertrophy

Keywords

influenza, LAIV, immune response

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fluenz vaccine

Arm Type

Experimental

Arm Description

LAIV vaccine

Intervention Type

Drug

Intervention Name(s)

FLUENZ

Other Intervention Name(s)

FLUMIST

Intervention Description

live attenuated influenza vaccine

Primary Outcome Measure Information:

Title

evaluation of the systemic and local immune response after live attenuated influenza vaccine.

Description

Measurement of systemic and local immune responses in immunological assays

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Influenza specific responses

Description

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

Time Frame

31.12.2015

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Jørgen Aarstad

Organizational Affiliation

Haukeland University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Haukeland University Hospital

City

Bergen

ZIP/Postal Code

N5021

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

31250024

Citation

Lartey S, Zhou F, Brokstad KA, Mohn KG, Slettevoll SA, Pathirana RD, Cox RJ. Live-Attenuated Influenza Vaccine Induces Tonsillar Follicular T Helper Cell Responses That Correlate With Antibody Induction. J Infect Dis. 2020 Jan 1;221(1):21-32. doi: 10.1093/infdis/jiz321.

Results Reference

result

PubMed Identifier

31269273

Citation

Islam S, Zhou F, Lartey S, Mohn KGI, Krammer F, Cox RJ, Brokstad KA. Functional immune response to influenza H1N1 in children and adults after live attenuated influenza virus vaccination. Scand J Immunol. 2019 Oct;90(4):e12801. doi: 10.1111/sji.12801. Epub 2019 Sep 2.

Results Reference

result

PubMed Identifier

28899626

Citation

Islam S, Mohn KG, Krammer F, Sanne M, Bredholt G, Jul-Larsen A, Tete SM, Zhou F, Brokstad KA, Cox RJ. Influenza A haemagglutinin specific IgG responses in children and adults after seasonal trivalent live attenuated influenza vaccination. Vaccine. 2017 Oct 9;35(42):5666-5673. doi: 10.1016/j.vaccine.2017.08.044. Epub 2017 Sep 9.

Results Reference

result

PubMed Identifier

28368530

Citation

Mohn KGI, Zhou F, Brokstad KA, Sridhar S, Cox RJ. Boosting of Cross-Reactive and Protection-Associated T Cells in Children After Live Attenuated Influenza Vaccination. J Infect Dis. 2017 May 15;215(10):1527-1535. doi: 10.1093/infdis/jix165.

Results Reference

result

PubMed Identifier

27789145

Citation

Manenti A, Tete SM, Mohn KG, Jul-Larsen A, Gianchecchi E, Montomoli E, Brokstad KA, Cox RJ. Comparative analysis of influenza A(H3N2) virus hemagglutinin specific IgG subclass and IgA responses in children and adults after influenza vaccination. Vaccine. 2017 Jan 3;35(1):191-198. doi: 10.1016/j.vaccine.2016.10.024. Epub 2016 Oct 24.

Results Reference

result

PubMed Identifier

27247344

Citation

Mohn KG, Brokstad KA, Pathirana RD, Bredholt G, Jul-Larsen A, Trieu MC, Lartey SL, Montomoli E, Tondel C, Aarstad HJ, Cox RJ. Live Attenuated Influenza Vaccine in Children Induces B-Cell Responses in Tonsils. J Infect Dis. 2016 Sep 1;214(5):722-31. doi: 10.1093/infdis/jiw230. Epub 2016 May 30. Erratum In: J Infect Dis. 2016 Oct 3;:

Results Reference

result

PubMed Identifier

26148331

Citation

Panapasa JA, Cox RJ, Mohn KG, Aqrawi LA, Brokstad KA. The expression of B & T cell activation markers in children's tonsils following live attenuated influenza vaccine. Hum Vaccin Immunother. 2015;11(7):1663-72. doi: 10.1080/21645515.2015.1032486.

Results Reference

result

PubMed Identifier

25425696

Citation

Mohn KG, Bredholt G, Brokstad KA, Pathirana RD, Aarstad HJ, Tondel C, Cox RJ. Longevity of B-cell and T-cell responses after live attenuated influenza vaccination in children. J Infect Dis. 2015 May 15;211(10):1541-9. doi: 10.1093/infdis/jiu654. Epub 2014 Nov 25.

Results Reference

result

PubMed Identifier

25039393

Citation

Pidelaserra Marti G, Isdahl Mohn KG, Cox RJ, Brokstad KA. The influence of tonsillectomy on total serum antibody levels. Scand J Immunol. 2014 Nov;80(5):377-9. doi: 10.1111/sji.12213. No abstract available.

Results Reference

result

Links:

URL

http://www.influensasenteret.no

Description

Influenza Centre

Learn more about this trial

Immune Response To Intranasal Influenza Vaccination

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