BELIEVE v1.0
Research type
Research Study
Full title
Broadening our understanding of Early versus Late InfluEnza Vaccine Effectiveness (BELIEVE)
IRAS ID
284733
Contact name
Manish Pareek
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
It is important that health care workers (HCWs) are vaccinated against seasonal influenza virus. Vaccination of HCWs limits the spread of influenza in a health care setting and reduces the risk of vulnerable groups such as the elderly from acquiring the infection in hospital.
The influenza season in Leicester occurs between December and May. It is important that the vaccination given to HCWs offers effective protection of the virus throughout these months. Data is limited but evidence suggests that the effectiveness of the vaccine may be significantly lower at the end of the season. This project aims to investigate if the protection from the seasonal influenza vaccine decreases over the influenza season, and when the best time to vaccinate HCWs would be.
The study will recruit 400 HCWs from Leicester Royal Infirmary prior to the 2020/21 influenza season. One group of HCWs will be vaccinated roughly 3 months before the influenza season and the other just one month prior to the start of the influenza season.
The effectiveness of the vaccine will be measured in two ways.
The first is antibody checks which will be done at four different time points during the study. Specific antibodies are present in the blood and are produced following seasonal influenza vaccination. The antibody levels of the two groups vaccinated early and late will be compared. An antibody level above a certain threshold suggests the participant is protected against infection.
The influenza vaccine is not 100% effective and the second method will compare the number of influenza infections that occur between the two groups. HCWs that develop influenza like illness will take a swab to confirm the diagnosis. These HCWs with the addition of 70 inpatients will have breath samples collected to evaluate two new techniques for diagnosing influenza infection.REC name
Wales REC 6
REC reference
20/WA/0247
Date of REC Opinion
15 Sep 2020
REC opinion
Further Information Favourable Opinion