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Immune Response To Intranasal Influenza Vaccination

NCT ID: NCT01866540

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Tonsillitis, Hypertrophy

Keywords

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influenza, LAIV, immune response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fluenz vaccine

LAIV vaccine

Group Type EXPERIMENTAL

FLUENZ

Intervention Type DRUG

live attenuated influenza vaccine

Interventions

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FLUENZ

live attenuated influenza vaccine

Intervention Type DRUG

Other Intervention Names

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FLUMIST

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Cox

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans Jørgen Aarstad

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 31250024 (View on PubMed)

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.

Reference Type RESULT
PMID: 31269273 (View on PubMed)

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.

Reference Type RESULT
PMID: 28899626 (View on PubMed)

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.

Reference Type RESULT
PMID: 28368530 (View on PubMed)

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.

Reference Type RESULT
PMID: 27789145 (View on PubMed)

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.

Reference Type RESULT
PMID: 27247344 (View on PubMed)

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.

Reference Type RESULT
PMID: 26148331 (View on PubMed)

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.

Reference Type RESULT
PMID: 25425696 (View on PubMed)

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.

Reference Type RESULT
PMID: 25039393 (View on PubMed)

Related Links

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http://www.influensasenteret.no

Influenza Centre

Other Identifiers

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2012-002848-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LAIV-tonsilsv2 Version 2

Identifier Type: -

Identifier Source: org_study_id