E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The immune response to Hepatitis B vaccine is being investigated. |
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E.1.1.1 | Medical condition in easily understood language |
The immune response to Hepatitis B vaccine is being investigated. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019732 |
E.1.2 | Term | Hepatitis B antibody |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054130 |
E.1.2 | Term | Hepatitis B immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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. |
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E.5.2 | 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). |
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E.5.2.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
same treatment is given at morning, afternoon and evening |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will complete after analyses of last sample. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 15 |