Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness (BELIEVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570904
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
Sanofi Pasteur, a Sanofi Company
World Health Organization
University of Warwick
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester

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.


Condition or disease Intervention/treatment
Influenza Influenza -Like Illness Biological: Influenza vaccination at different time points

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 470 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Broadening Our Understanding of Early Versus Late Influenza Vaccine
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Early HCWs
Health Care Workers vaccinated early prior to the influenza season
Biological: Influenza vaccination at different time points
All HCWs will receive the seasonal influenza vaccine but at two different time points.

Late HCWs
Health Care Workers vaccinated just prior to the influenza season
Biological: Influenza vaccination at different time points
All HCWs will receive the seasonal influenza vaccine but at two different time points.

Inpatients
Inpatients recruited for evaluation of new approaches to influenza diagnosis



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Influenza infections [ Time Frame: Influenza positive swabs to be analysed at the end of the study once all samples collected - estimated May 2021 ]
    The number of laboratory-confirmed influenza infections by real time PCR in HCWs vaccinated early and late

  2. Breath analysis for influenza diagnosis [ Time Frame: Results to be analysed post influenza season - estimated May 2021 ]
    The detection of markers of influenza infection in breath samples using GC-IMS, eNose and GC-MS

  3. Mask sampling for influenza diagnosis [ Time Frame: Results to be analysed post influenza season - estimated May 2021 ]
    The detection of influenza by PCR using a novel mask sampling technique


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
  • Age ≥16

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570904


Contacts
Layout table for location contacts
Contact: Joshua Nazareth, MBBS 07743672808 joshua.nazareth@nhs.net
Contact: Sally Batham, MSc 07824372118 ext 0116 2587558 seb38@leicester.ac.uk

Locations
Layout table for location information
United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Contact: Sally Batham, MSc    0116 2587558    seb38@leicester.ac.uk   
Contact: Joshua Nazareth, MBBS    07743672808    joshua.nazareth@nhs.net   
Sponsors and Collaborators
University of Leicester
Sanofi Pasteur, a Sanofi Company
World Health Organization
University of Warwick
University Hospitals, Leicester
Investigators
Layout table for investigator information
Principal Investigator: Manish Pareek, PhD University of Leicester
Layout table for additonal information
Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04570904    
Other Study ID Numbers: 0787
IRAS ( Other Identifier: 284733 )
Sponsor Reference Number ( Other Identifier: UOL0787 )
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The participants will be identified only by initials and a participant ID number on the CRF and any electronic database. All documents will be stored securely and only accessible by study staff and authorised personnel. The study will comply with the Data Protection Act which requires data to be anonymised as soon as it is practical to do so.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Leicester:
Seasonal influenza vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs