NCT04110366|CompletedResults
Nasal and Systemic Immune Responses to Nasal Influenza Vaccine
Flu-M3
Kinetics of Mucosal and Systemic Immune Responses to Intranasal Live Attenuated Influenza Vaccine (LAIV)
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Sponsor study identifier
interventional
48
1 country
1
Study Start
June 14, 2018
Actual (reported)Primary Completion
April 4, 2019
Actual (reported)Study Completion
May 29, 2020
Actual (reported)Intranasal live attenuated influenza vaccine (LAIV; trade name FluMist/Fluenz-Tetra, manufactured by AstraZeneca/Medimmune) is the standard influenza vaccine given to children aged 2-17 years of age in the UK. It is also licensed to be given to adults up to the age of 49 years in the USA. The systems biology of the human blood response to influenza vaccines has been studied in great detail, but there is a paramount need to study innate and specific, soluble and cellular immune responses at the nasal mucosal site of influenza infection. In this way this study aims to determine correlates of efficacy and vaccine take in serum and nasal mucosal lining fluid (MLF).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 29, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2018
Actual (reported)April 4, 2019
Actual (reported)September 9, 2019
Actual (reported)October 1, 2019
Actual (reported)May 29, 2020
Actual (reported)December 6, 2021
Actual (reported)Number of Participants Shedding Each Vaccine Virus Measured by qPCR of Nasosorption Samples
Vaccine virus shedding in nasosorption samples collected between 1-7 days post-vaccination and quantified using multiplex qPCR assay measures in the LAIV vaccine recipient cohort.
1-7 days post vaccination
Number of Participants With >2-fold Rise in Mucosal and/or Serum Antibody Titre Against Each Vaccine Virus Haemagglutinin Antigens
28 days post vaccination
Participants receiving live attenuated influenza vaccine (LAIV)
Participants receiving a vehicle control nasal challenge
Vaccination with live attenuated influenza vaccine (LAIV)
Vehicle control nasal challenge
Imperial Clinical Respiratory Research Unit
London, W2 1PG, United Kingdom
Thwaites RS, Uruchurtu ASS, Negri VA, Cole ME, Singh N, Poshai N, Jackson D, Hoschler K, Baker T, Scott IC, Ros XR, Cohen ES, Zambon M, Pollock KM, Hansel TT, Openshaw PJM. Early mucosal events promote distinct mucosal and systemic antibody responses to live attenuated influenza vaccine. Nat Commun. 2023 Dec 5;14(1):8053. doi: 10.1038/s41467-023-43842-7.
Peter J Openshaw, PhD
Imperial College London
Trevor T Hansel, PhD
Imperial College London
48 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2019
First Posted
October 1, 2019
Study Start
June 14, 2018
Actual (reported)Resistance Exercise to Improve Flu Vaccine for Older Adults
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 4, 2019
Actual (reported)Study Completion
May 29, 2020
Actual (reported)Last Updated
December 6, 2021
Results First Posted
December 6, 2021
Record last verified: 2021-11
IPD sharing is available upon request to the study PI; but access is offered at the discretion of the PI and requests are not guaranteed access. All access will require ethical approval.
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Source: ClinicalTrials.gov.
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