Broadening Our Understanding of Early Versus Late Influenza Vaccine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Leicester
- Enrollment
- 470
- Locations
- 1
- Primary Endpoint
- Difference in antibody titre
Study Overview
Brief Summary
This study uses a prospective cohort design to investigate if the seasonal influenza vaccine is equally effective when given early and late before the proceeding influenza season. All health care workers will be vaccinated for seasonal influenza either 3 months before or 1 month prior to the start of the influenza season. HCWs that consent to take part in the study will have 4 blood samples taken for an antibody check. The initial antibody checks will be done just prior to vaccination as well as 2 weeks after vaccination. Subsequent samples will be taken at the peak of influenza season and at the end of the influenza season.
HCWs that develop ILI during the course of the influenza season will be asked to complete a questionnaire and oropharyngeal self-swab. HCWs will also provide exhaled breath samples and wear a mask in order to evaluate novel non-invasive methods for diagnosis of influenza.
Influenza positive and negative inpatients identified through the University of Leicester's laboratory system will also be asked to provide breath samples to evaluate this technique for the diagnosis of influenza.
Detailed Description
Recruitment, Screening and Eligibility Assessment
Potential participants (University Hospitals of Leicester NHS Trust, UHL staff) will be contacted by email to advertise and explain the study. The email will be part of the routine seasonal influenza vaccination emails which are sent out each year to remind UHL staff to be immunised. In addition, the investigators will advertise by posters in the high staff traffic areas, e.g. the restaurant, and our Occupational Health Team will assist with this advertising of the study. The investigators expect some Health care workers (HCWs) to become aware of the study through word of mouth.
The study will have two phases of recruitment. For the month of September for the 'early' vaccination group, and from mid-November to mid-December for the 'late' vaccination group - the exact timings may vary depending on when the inactivated influenza vaccines are received and the seasonality of the virus, as all recruitment will be completed prior to the start of the influenza season. Allocation to the two vaccination groups will not be randomised; it will be the HCWs decision if they would like to have the vaccination either early or late. There will be a limit of 200 HCWs recruited to each group.
Individuals who express an interest in taking part in the study will be given an information sheet either in person or via email. Following this the investigators will give them as long as they need to decide whether or not to participate in the study. If the individual agrees to participate, a member of the research team will screen and confirm eligibility. Participants will only be recruited if all criteria are satisfied. At this time arrangements will be made for staff members to attend an initial appointment at the Research Space at the LRI. Recruitment in the research area will comply with the current social distancing measures in place at UHL.
At this initial appointment the study will be explained to staff members in groups. A member of the research team will then seek written informed consent as detailed below from each HCW individually. If an individual has more questions about the study another study team member will be allowed to support and facilitate informed consent.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For Health care workers (HCWs)
- •Willing and able to give informed consent
- •Employee at the University Hospitals of Leicester
- •Willing and able to have the inactivated Influenza vaccine
- •Age ≥16 For inpatients
- •Inpatient at University Hospitals of Leicester
- •Throat swab for influenza completed in the last 72 hours
- •Willing and able to give informed consent
- •Well enough to provide an exhaled breath sample without causing distress or discomfort
- •Well enough to wear a face mask without causing distress or discomfort
Exclusion Criteria
- •Unwilling and/or unable to give informed written consent
Outcomes
Primary Outcomes
Difference in antibody titre
Time Frame: Antibody titres to be analysed at the end of the study once all samples collected - estimated May 2021
Difference in antibody titres at set time points during the 2020/21 influenza season in HCWs stratified by those who are vaccinated early and late
Secondary Outcomes
- Influenza infections(Influenza positive swabs to be analysed at the end of the study once all samples collected - estimated May 2021)
- Mask sampling for influenza diagnosis(Results to be analysed post influenza season - estimated May 2021)
- Breath analysis for influenza diagnosis(Results to be analysed post influenza season - estimated May 2021)