2024-513933-18-00
Not yet recruiting
Phase 4
(The Lion Trial) LAIV induced Immune respOnse in the Nasopharynx
Leids Universitair Medisch Centrum (LUMC)1 site in 1 country20 target enrollmentStarted: July 24, 2025Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
Identifying mucosal surrogates of protection following intranasal LAIV in children. Shedding of the LAIV is used as a surrogate for susceptibility to infection, with the expectation that the first dose of LAIV induces variable levels of immunity that confer protection against shedding of the second dose.
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between two and seven years old
- •Parents ability and willingness to adhere to protocol-specified procedures, including availability of a freezer at home to store samples. Donating blood is optional as this is a secondary endpoint.
Exclusion Criteria
- •Recipient of any influenza vaccine (both LAIV or IIV) in the same or a previous flu-season.
- •Recipient of any other vaccine within one month prior to inclusion-date.
- •Meeting one or more contraindications for the Fluenz vaccine as stated in paragraph 6.3 of the protocol.
- •Substantial language barrier of either potential subject or parent. Participants and their parents are asked to self-collect samples during this trial, therefore instructions need be given and adequately understood.
Outcomes
Primary Outcomes
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.
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 Outcomes
- 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.
Investigators
Maurits Thomas Wulffraat
Scientific
Leids Universitair Medisch Centrum (LUMC)
Study Sites (1)
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