Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1188 participants
INTERVENTIONAL
2020-10-19
2023-01-31
Brief Summary
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A secondary aim is to establish whether changes in psychosocial and lifestyle factors during training impact immune health (e.g. response to hepatitis B vaccination). Using an interventional design, participants will be randomly allocated into two experimental groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
For aim 2, the recruited cohort will be divided into two groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.
BASIC_SCIENCE
NONE
Study Groups
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Routine vaccination (Control)
No interventions assigned to this group
Delay vaccination (Experimental)
Delayed vaccination
First and second hepatitis B vaccinations will be delayed by 1 month in the interventional group to establish whether changes in psychosocial and lifestyle factors during training impact immune health.
Interventions
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Delayed vaccination
First and second hepatitis B vaccinations will be delayed by 1 month in the interventional group to establish whether changes in psychosocial and lifestyle factors during training impact immune health.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
33 Years
ALL
Yes
Sponsors
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University of Nottingham
OTHER
University of California, Los Angeles
OTHER
Loughborough University
OTHER
Ministry of Defence, United Kingdom
OTHER_GOV
Liverpool John Moores University
OTHER
Responsible Party
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Principal Investigators
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Neil P Walsh, PHD
Role: PRINCIPAL_INVESTIGATOR
Liverpool John Moores University
Locations
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Infantry Training Centre
Catterick, North Yorkshire, United Kingdom
Countries
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Other Identifiers
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1070/MODREC/20
Identifier Type: -
Identifier Source: org_study_id
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