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)
1 other identifier
interventional
48
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
June 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2019
CompletedFirst Submitted
Initial submission to the registry
September 9, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2020
CompletedResults Posted
Study results publicly available
December 6, 2021
CompletedDecember 6, 2021
November 1, 2021
10 months
September 9, 2019
August 26, 2021
November 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of Participants With >2-fold Rise in Mucosal and/or Serum Antibody Titre Against Each Vaccine Virus Haemagglutinin Antigens
28 days post vaccination
Study Arms (2)
Live attenuated influenza vaccine
EXPERIMENTALParticipants receiving live attenuated influenza vaccine (LAIV)
Mucosal immune stability cohort
EXPERIMENTALParticipants receiving a vehicle control nasal challenge
Interventions
Vaccination with live attenuated influenza vaccine (LAIV)
Eligibility Criteria
You may qualify if:
- Capacity to provide written informed consent
- Aged 18-30 years (inclusive)
- Fluent English speaker
You may not qualify if:
- Current involvement in another study unless observational or in follow-up phase (non-interventional)
- Received any influenza vaccine over the last 2 years
- Egg allergy
- Previous significant adverse reaction to any vaccination/immunisation
- Current regular (daily) smoker
- Pregnant
- Any medication that may affect the immune system (e.g. steroids)
- Taking regular acetylsalicylic acid (aspirin)
- Unable to give informed consent
- Current acute severe febrile illness
- Taking long term antibiotics
- Clinically diagnosed influenza in the last 2 years
- Any long-term health problem with heart disease, lung disease (including asthma), kidney disease, neurologic disease, liver disease, metabolic disease (e.g. diabetes) or anemia or another blood disorder
- Use of drugs for the treatment of rheumatoid arthritis, Crohn's disease, or psoriasis or anticancer drugs; or radiation treatments
- History of Guillain-Barre syndrome
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial Clinical Respiratory Research Unit
London, W2 1PG, United Kingdom
Related Publications (1)
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.
PMID: 38052824DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Ryan Thwaites
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Openshaw, PhD
Imperial College London
- STUDY DIRECTOR
Trevor T Hansel, PhD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2019
First Posted
October 1, 2019
Study Start
June 14, 2018
Primary Completion
April 4, 2019
Study Completion
May 29, 2020
Last Updated
December 6, 2021
Results First Posted
December 6, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR, ANALYTIC CODE
- Time Frame
- From June 2020 onward, no set end date
- Access Criteria
- PI discretion
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.