Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness

NCT04570904 | Completed

• 3 other identifiers: 0787IRASSponsor Reference Number
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Influenza -Like Illness

Keywords

Seasonal influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Difference in antibody titre

  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

  Antibody titres to be analysed at the end of the study once all samples collected - estimated May 2021

Secondary Outcomes (3)

• Influenza infections

  Influenza positive swabs to be analysed at the end of the study once all samples collected - estimated May 2021

• Breath analysis for influenza diagnosis

  Results to be analysed post influenza season - estimated May 2021

• Mask sampling for influenza diagnosis

  Results to be analysed post influenza season - estimated May 2021

Study Arms (3)

Early HCWs

Health Care Workers vaccinated early prior to the influenza season

Biological: Influenza vaccination at different time points

Late HCWs

Health Care Workers vaccinated just prior to the influenza season

Biological: Influenza vaccination at different time points

Inpatients

Inpatients recruited for evaluation of new approaches to influenza diagnosis

Interventions

Influenza vaccination at different time points BIOLOGICAL

All HCWs will receive the seasonal influenza vaccine but at two different time points.

Early HCWs; Late HCWs

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of HCWs at University Hospitals of Leicester, that are eligible for the seasonal influenza vaccine A further study population will be composed of inpatients at the University Hospitals of Leicester presenting and / or admitted with Influenza like illness

You may qualify if:

• 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
• Age ≥16

You may not qualify if:

• Age \<16
• Unwilling and/or unable to give informed written consent

Sponsors & Collaborators

• University of Leicester: lead
• Sanofi Pasteur, a Sanofi Company: collaborator
• World Health Organization: collaborator
• University of Warwick: collaborator
• University Hospitals, Leicester: collaborator

Study Sites (1)

Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Related Publications (1)

• Nazareth J, Barr I, Sullivan SG, Goss C, Pan D, Martin CA, Sahota A, Stephenson I, Tang JW, Pareek M. Intra-season waning of immunity following the seasonal influenza vaccine in early and late vaccine recipients. J Infect. 2022 Dec;85(6):e172-e174. doi: 10.1016/j.jinf.2022.10.011. Epub 2022 Oct 13. No abstract available.

  PMID: 36243199 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

With participant consent, any unused serum samples will be stored for future ethically approved research and shared with other research collaborators in other academic institutions and industry partners inside and outside of the UK for future research.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Manish Pareek, PhD

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: September 28, 2020
• Primary Completion: May 30, 2021
• Study Completion: September 1, 2021
• Last Updated: January 19, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)