The immune response to Hepatitis B vaccine is being investigated. MedDRA version: 20.1 Level: PT Classification code 10019732 Term: Hepatitis B antibody System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and med
Conditions
Interventions
Trade Name: Engerix B®
Product Name: Engerix B®
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Recombinant Hep
Sponsors
Central Manchester University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age more than or equal to16 years. University student in good health who consents to fill diary cards, provide saliva and blood samples and is able to attend a morning/afternoon/evening vaccination session Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - History of HepB infection or vaccination - Immunosuppression including HIV or chronic/current steroid use - Receipt of blood products or IgG within 3 months of enrolment - Any contraindication to Hepatitis B vaccination per Green Book
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The time point for the evaluation of the primary outcome will be after a blood sample has been collected one month after last vaccine dose.; Main Objective: Our principal research question is: 'How does the time of day of first vaccination affect the immune response to Hepatitis B vaccine?' Our primary objectives in the study are •Establish the procedures for a definitive investigation into time of day and vaccine responses. •Evaluate the difference in Hepatitis B antibody (Anti-HBs) titres of morning, afternoon and evening vaccination groups after 3 doses of Hepatitis B vaccination. ; Secondary Objective: In this preliminary study, secondary objectives won't be analysed. However, the following exploratory objects will be analysed. •Evaluate differences between morning, afternoon and evening first vaccination groups for the following exploratory outcomes: -Anti-HBs levels after 1st vaccination -Quality of T cell responses after primary vaccination •Explore specific chronotypes in relation to time of day of vaccination and vaccination outcomes ; Primary end point(s): In this pilot study, our objective is to establish the procedures we will use in a definitive study of circadian rhythm, the time of day and vaccine responses. To answer our research question, 'How does the time of day of first vaccination affect the immune response to Hepatitis B vaccine?' we will be using the anti Hepatitis B surface antigen antibody concentration after three doses of Hepatitis B vaccine as our primary outcome measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In this preliminary study, there are no secondary end-points. However, exploratory end-points are: 1. Hepatitis B antibody levels after first and second HBV vaccinations 2. Quality of T-cell immune responses after first vaccination in relationship to (a) time of day of vaccination, and (b) to specific chronotypes (sleep/wake patterns). ; Timepoint(s) of evaluation of this end point: 1. Hepatitis B antibody levels after first and second HBV vaccinations: This will be analysed from blood tests done at 1 and 2 months after first vaccination. 2. Quality of T-cell immune responses after first vaccination: Part of the analyses will be done from blood tests one month after first vaccination. Final analyses will be performed one month after last vaccination. | — |
Countries
United Kingdom
Contacts
Public ContactLynne Webster
Central Manchester University Hospitals NHS Foundation Trust
Outcome results
None listed