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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04780867
Other study ID # 1070/MODREC/20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2020
Est. completion date January 31, 2023

Study information

Verified date April 2023
Source Liverpool John Moores University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Psychosocial and lifestyle factors in Army recruits likely contribute to increased susceptibility to infection and injury during basic Army training. The primary aim of this study is to assess the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training, in an observational design. 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.


Recruitment information / eligibility

Status Completed
Enrollment 1188
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 33 Years
Eligibility Inclusion Criteria: Men and women aged 16-33 years enrolled in phase one British Army training Exclusion Criteria: -

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
United Kingdom Infantry Training Centre Catterick North Yorkshire

Sponsors (5)

Lead Sponsor Collaborator
Liverpool John Moores University Loughborough University, Ministry of Defence, United Kingdom, University of California, Los Angeles, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody response to influenza vaccination - Aim 1 1 month
Primary Physician diagnosed respiratory infection incidence - Aim 1 6 months
Primary Physician diagnosed injury incidence - Aim 1 6 months
Primary Antibody response to second hepatitis B vaccination - Aim 2 Routine group: 3 months; Delay group: 4 months
Secondary Antibody response to influenza vaccination 4 months
Secondary Antibody response to first hepatitis B vaccination Routine group: 1 months; Delay group: 2 months
Secondary C-reactive protein Baseline, 1-day post vaccination and 1 month
Secondary Gene expression profiling Baseline and 1 month
Secondary Epstein Barr Virus serostatus/antibody titre Baseline and 1 month
Secondary Cytomegalovirus serostatus/antibody titre Baseline and 1 month
Secondary Torque Teno Virus plasma DNA Baseline and 1 month
Secondary Interleukin-6 Baseline and 1 month
Secondary Hair cortisol Baseline
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