Status:
COMPLETED
Nasal and Systemic Immune Responses to Nasal Influenza Vaccine
Lead Sponsor:
Imperial College Healthcare NHS Trust
Conditions:
Influenza
Vaccine Virus Shedding
Eligibility:
All Genders
18-30 years
Phase:
NA
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 i...
Detailed Description
This study will collect serial samples prior to vaccination and at intervals up to day 28 post-vaccination to establish the kinetics of the nasal mucosal and blood systemic response to LAIV in young a...
Eligibility Criteria
Inclusion
- Capacity to provide written informed consent
- Aged 18-30 years (inclusive)
- Fluent English speaker
Exclusion
- 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
- Live with or expect to have close contact with a person whose immune system is severely compromised and who must be in protective isolation (e.g., an isolation room of a bone marrow transplant unit)
- Received any other vaccinations in the past 4 weeks
Key Trial Info
Start Date :
June 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04110366
Start Date
June 14 2018
End Date
May 29 2020
Last Update
December 6 2021
Active Locations (1)
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1
Imperial Clinical Respiratory Research Unit
London, United Kingdom, W2 1PG