Clinical Trial Results:
A pilot study evaluating the influence of chronobiology on Hepatitis B responses in health-care students attending the University of Salford
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Summary
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EudraCT number |
2014-003756-32 |
Trial protocol |
GB |
Global end of trial date |
10 Apr 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Feb 2020
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First version publication date |
07 Feb 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
R03930
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
REC reference: 15/EE/0119 | ||
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Sponsors
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Sponsor organisation name |
Manchester University NHS Foundation Trust
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Sponsor organisation address |
29 Grafton Street, Manchester, United Kingdom, M13 9WU
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Public contact |
Dr Lynne Webster, Head of the Research Office, Manchester University NHS Foundation Trust, +44 01612764125, lynne.webster@mft.nhs.uk
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Scientific contact |
Dr Lynne Webster, Head of the Research Office, Manchester University NHS Foundation Trust, +44 01612764125, lynne.webster@mft.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Apr 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Apr 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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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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Protection of trial subjects |
1. Additional blood tests: Trial subjects will undergo additional blood tests. All potential participants will be informed of this prior to recruitment and only those who are willing for the same will be recruited into the trial. These blood tests will be an additional point of contact with the trial personnel.
2. Morning vs evening vaccination: Participants will be required to attend their first appointment within a narrow time window during the morning and late in the evening. This will be discussed in advance with participants. Reasonable travel expenses in order to attend study visits will be reimbursed.
3. Collection of saliva sample: Participants will be expected to provide saliva samples on the night before and immediately on waking the day of vaccination. This will be detailed in the PIL and discussed at the screening visit. Samples are provided by the subject at their home and does not require any additional vaccination.
4. Completion of questionnaires: Potential subjects will be asked to fill in questionnaires (Munich Chronotype Questionnaire and sleep diary). Participants will be informed of the need to do this prior to enrolment and only those prepared to do so will be enrolled.
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Background therapy |
N/A | ||
Evidence for comparator |
There is no placebo or control group for this trial. | ||
Actual start date of recruitment |
11 Aug 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
99999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
First year nursing students who were admitted in the spring term and who will require vaccinations prior to entry into the course will be provided information (written and verbal) about the study by Occupational health. Once subjects have expressed interest in the study, details of participants will be provided to the research team with consent. | ||||||||||||||||
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Pre-assignment
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Screening details |
Inclusion: - Age older than or equal to 16 years - University student in good health who consent to complete sleep diary,Munich chronotype questionnaire and attend am/pm appointments | ||||||||||||||||
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Period 1
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Period 1 title |
Hepatitis B vaccination (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||
Roles blinded |
Assessor [1] | ||||||||||||||||
Blinding implementation details |
Participants are randomised to receive the Hepatitis B vaccine either in the morning, afternoon or evening. Analysis of the blood samples was conducted by a blinded member of staff.
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Arms
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Arm title
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Hepatitis B vaccination | ||||||||||||||||
Arm description |
Participants will receive Engerix B® 20 micrograms/1 ml, give as 3 doses of 20 micrograms at 0, 1 and 6 months. | ||||||||||||||||
Arm type |
IMP given in morning | ||||||||||||||||
Investigational medicinal product name |
Engerix B® 20 micrograms/1 ml
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Investigational medicinal product code |
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Other name |
PL 10592/0165
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 doses of 20 micrograms given at 0,1 and 6 months. The vaccine stimulates the production of Anti Hepatitis B surface antigen antibodies and other components of the immune system. AntiHBs antibody concentrations > 10 IU/l correlate with protection to HBV infection.
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| Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Analysis of blood samples was to be performed by a blinded member of staff. No other staff member was blinded. It was not possible for the patient to be blinded as the randomisation was for time of day to take the drug. |
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Baseline characteristics reporting groups
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Reporting group title |
Hepatitis B vaccination
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
99999
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
99999
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End points reporting groups
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Reporting group title |
Hepatitis B vaccination
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Reporting group description |
Participants will receive Engerix B® 20 micrograms/1 ml, give as 3 doses of 20 micrograms at 0, 1 and 6 months. | ||
Subject analysis set title |
99999
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
99999
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End point title |
To establish the procedures we will use in a definitive study of circadian rhythm, the time of day and vaccine responses [1] | ||||||
End point description |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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End point type |
Primary
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End point timeframe |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No subjects were enrolled in the trial hence results are not available |
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| Notes [2] - No subjects were enrolled in the trial hence results are not available |
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| No statistical analyses for this end point | |||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
This study concerns an IMP prescribed within its licensed indication, dosage and form for clinical purposes. Subjects will be questioned, at visit 3 only, for reports of Serious Adverse Events.
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Adverse event reporting additional description |
These events will be reported to the Sponsor, the MHRA and the REC in accordance with the regulatory guidelines. An Annual Safety Report will be submitted. We do not propose to monitor or record Adverse Event or Adverse Reaction data. No AEs occurred within this trial as it was terminated prior to screening/recruitment.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No patients were screened or entered onto the trial. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Jun 2016 |
A. Protocol amendment: The protocol has been amended to include the following:
-Change in Vaccine schedule: The University of Salford study site is adopting the accelerated schedule for Hepatitis B vaccination. Hence the study timeline for vaccination will change from 0, 1 and 6 months to 0, 1 and 2 months.
-Study groups and numbers: In addition to morning and evening vaccination, an additional time point to reflect current standard of care (1-2pm) has been added. Study group numbers have been revised from 30 in each group to 20 in each group with a total of 60 subjects.
-Additional blood sample: An additional blood sample will be collected opportunistically when subject attends for third dose of the vaccine, hence current venepuncture schedule is 0, 1, 2 and 3 months.
B. Patient Information Leaflet and Consent forms have been revised to reflect the above changes
C. We have added a section to the protocol to cover adverse event reporting.
REC favourable opinion was issued 04/07/2016. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial | |||
