NCT01866540

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Oct 2012Dec 2030

Study Start

First participant enrolled

October 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

13.3 years

First QC Date

October 22, 2012

Last Update Submit

December 5, 2023

Conditions

Tonsillitis, Hypertrophy

Keywords

influenza, LAIV, immune response

Outcome Measures

Primary Outcomes (1)

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

    Measurement of systemic and local immune responses in immunological assays

    1 year

Other Outcomes (1)

  • Influenza specific responses

    31.12.2015

Study Arms (1)

Fluenz vaccine

EXPERIMENTAL

LAIV vaccine

Drug: FLUENZ

Interventions

FLUENZDRUG

live attenuated influenza vaccine

Also known as: FLUMIST
Fluenz vaccine

Eligibility Criteria

Age2 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, N5021, Norway

Location

Related Publications (9)

  • 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.

    PMID: 31250024RESULT

  • 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.

    PMID: 31269273RESULT

  • 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.

    PMID: 28899626RESULT

  • 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.

    PMID: 28368530RESULT

  • 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.

    PMID: 27789145RESULT

  • 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.

    PMID: 27247344RESULT

  • 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.

    PMID: 26148331RESULT

  • 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.

    PMID: 25425696RESULT

  • 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.

    PMID: 25039393RESULT

Related Links

MeSH Terms

Conditions

TonsillitisHypertrophyInfluenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Study Officials

  • Hans Jørgen Aarstad

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2012

First Posted

May 31, 2013

Study Start

October 1, 2012

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations

NO(1)