Immune Health, Injury, Psychological, Respiratory Tract Infections, Stress, Vaccination
Conditions
Brief 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.
Interventions
BEHAVIORALDelayed 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.
Sponsors
University of Nottingham
University of California, Los Angeles
Loughborough University
Ministry of Defence, United Kingdom
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
For aim 1, an observational design will be used to examine 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. 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 33 Years
Healthy volunteers
Yes
Inclusion criteria
Men and women aged 16-33 years enrolled in phase one British Army training
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody response to influenza vaccination - Aim 1 | 1 month |
| Physician diagnosed respiratory infection incidence - Aim 1 | 6 months |
| Physician diagnosed injury incidence - Aim 1 | 6 months |
| Antibody response to second hepatitis B vaccination - Aim 2 | Routine group: 3 months; Delay group: 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Epstein Barr Virus serostatus/antibody titre | Baseline and 1 month |
| Cytomegalovirus serostatus/antibody titre | Baseline and 1 month |
| Antibody response to influenza vaccination | 4 months |
| Interleukin-6 | Baseline and 1 month |
| Hair cortisol | Baseline |
| Torque Teno Virus plasma DNA | Baseline and 1 month |
| Antibody response to first hepatitis B vaccination | Routine group: 1 months; Delay group: 2 months |
| C-reactive protein | Baseline, 1-day post vaccination and 1 month |
| Gene expression profiling | Baseline and 1 month |
Countries
United Kingdom
Outcome results
None listed