N/A
N=48
Nasal and Systemic Immune Responses to Nasal Influenza Vaccine
Influenza · Vaccine Virus Shedding
Bottom Line
View on ClinicalTrials.gov: NCT04110366 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants Shedding Each Vaccine Virus Measured by qPCR of Nasosorption Samples — 31 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Live attenuated influenza vaccine (Biological); Vehicle control (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Shedding Each Vaccine Virus Measured by qPCR of Nasosorption Samples |
31 | — |
| SECONDARY Number of Participants With >2-fold Rise in Mucosal and/or Serum Antibody Titre Against Each Vaccine Virus Haemagglutinin Antigens |
28 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Capacity to provide written informed consent
- Aged 18-30 years (inclusive)
- Fluent English speaker
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04110366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.