(The Lion Trial) LAIV induced Immune respOnse in the Nasopharynx

Conditions

Influenza

Brief summary

Presence or absence of viral shedding of vaccine-strains after first and second dose of LAIV in nasal lining fluid, collected using nasosorptions and analyzed with RT-qPCR.

Detailed description

LAIV shedding kinetics (density and duration) during first and second dose of LAIV, measured in nasal lining fluid using nasosorptions and analyzed with RT-qPCR., Change in influenza specific mucosal antibodies (including IgA) in nasal lining fluid before and after first and second dose of LAIV. Measured in nasal lining fluid from nasosorptions and analyzed for binding and/or functional capacity., Nasal immune responses during LAIV, with soluble proteins measured in nasal lining fluid from nasosorption samples., Nasal colonization and infection dynamics by other URT bacteria and viruses, comparing composition before and after LAIV. Samples will be collected using nasosorptions and analyzed with molecular methods., Analysis of peripheral immune system in whole blood collected at baseline and 28 days post LAIV dose 1. Measured using tools such as spectral flow cytometry., Serum and mucosal IgG and IgA post-LAIV, comparing baseline to day 28 post-LAIV. Measured through binding and functional assays., Correlating immune responses and shedding kinetics with data from baseline questionnaire and daily questionnaires assessing RTI-related symptoms. Collected using electronic recordings.

Related papers

No related papers found yet.

Interventions

DRUGFluenz nasal spray suspension Influenza vaccine (live attenuated

DRUGnasal)

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Presence or absence of viral shedding of vaccine-strains after first and second dose of LAIV in nasal lining fluid, collected using nasosorptions and analyzed with RT-qPCR.	—

Secondary

Measure	Time frame
LAIV shedding kinetics (density and duration) during first and second dose of LAIV, measured in nasal lining fluid using nasosorptions and analyzed with RT-qPCR., Change in influenza specific mucosal antibodies (including IgA) in nasal lining fluid before and after first and second dose of LAIV. Measured in nasal lining fluid from nasosorptions and analyzed for binding and/or functional capacity., Nasal immune responses during LAIV, with soluble proteins measured in nasal lining fluid from nasosorption samples., Nasal colonization and infection dynamics by other URT bacteria and viruses, comparing composition before and after LAIV. Samples will be collected using nasosorptions and analyzed with molecular methods., Analysis of peripheral immune system in whole blood collected at baseline and 28 days post LAIV dose 1. Measured using tools such as spectral flow cytometry., Serum and mucosal IgG and IgA post-LAIV, comparing baseline to day 28 post-LAIV. Measured through binding and functio	—

Measure

Time frame

LAIV shedding kinetics (density and duration) during first and second dose of LAIV, measured in nasal lining fluid using nasosorptions and analyzed with RT-qPCR., Change in influenza specific mucosal antibodies (including IgA) in nasal lining fluid before and after first and second dose of LAIV. Measured in nasal lining fluid from nasosorptions and analyzed for binding and/or functional capacity., Nasal immune responses during LAIV, with soluble proteins measured in nasal lining fluid from nasosorption samples., Nasal colonization and infection dynamics by other URT bacteria and viruses, comparing composition before and after LAIV. Samples will be collected using nasosorptions and analyzed with molecular methods., Analysis of peripheral immune system in whole blood collected at baseline and 28 days post LAIV dose 1. Measured using tools such as spectral flow cytometry., Serum and mucosal IgG and IgA post-LAIV, comparing baseline to day 28 post-LAIV. Measured through binding and functio

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Countries

Netherlands

Outcome results

None listed