Influence of chronobiology on Hepatitis B vaccine responses
Research type
Research Study
Full title
A pilot study evaluating the influence of chronobiology on Hepatitis B responses in health-care students attending the University of Salford
IRAS ID
162799
Contact name
Stephen Hughes
Contact email
Sponsor organisation
Central Manchester University Hospitals and NHS Foundation Trust
Eudract number
2014-003756-32
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
Vaccination is considered to be the most cost-effective life-saving medical intervention in history; yet three million children die every year of vaccine preventable diseases. Vaccine preventable deaths occur largely due to suboptimal vaccine coverage (as evidenced by the recent measles epidemic in Wales) but also due to vaccine failure. Most vaccines in use are imperfect and do not provide universal protection despite repeated doses. Depending on the specific vaccine, vaccine failure occurs rarely (tetanus) or more commonly (influenza, pertussis, hepatitis B). Factors determining vaccine response are multiple and complex. Some are genetic and others are environmental. Recent research in mice has shown that the timing of vaccine administration (morning vs evening) may affect immune response.
Our research question is, 'Does timing of of vaccination have an effect on vaccine responses in humans?'
We have chosen Hepatitis B vaccination because Hepatitis B is a global health priority with potential to cause chronic diseases including liver cancer. Also, Hepatitis B vaccine (HBV) generates a protective response only after three doses in 85-95% of vaccinees and as such there is scope for improvement.
In this pilot study, we plan to establish the procedures so that a full randomised controlled trial can be subsequently performed successfully. All unvaccinated, nursing students at the University of Salford will be provided with information leaflets and 60 consenting individuals will be randomised to two groups (morning vaccination vs evening vaccination). Saliva and blood samples will be collected before and after vaccination. Subjects will be asked to provide demographic and sleep data.
The output of this study could affect vaccination policy. Improving vaccine outcomes by manipulating time of vaccination is a novel and highly cost-effective strategy. It could decrease the overall number of doses required to produce satisfactory immune response thus translating into cost benefits for the NHS.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0119
Date of REC Opinion
22 Apr 2015
REC opinion
Further Information Favourable Opinion