PsychologicalNCT04780867
Psychological and Lifestyle Factors on Health Outcomes
A study testing Delayed vaccination in people with Psychological and Stress, run by Liverpool John Moores University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological, Stress, Immune Health
- What is being tested?
- Delayed vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,188 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 33 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Men and women aged 16-33 years enrolled in phase one British Army training
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Infantry Training Centre
Catterick, North Yorkshire, DL9 3PS
About this study
Official title: The Influence of Psychosocial and Lifestyle Factors on Immune Health and Injury Incidence During Phase One Training in UK Army Recruits
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.
- Conditions
- Psychological, Stress, Immune Health, Vaccination, Respiratory Tract Infections, Injury
- Being tested
- Delayed vaccination
- Medical subject headings
- Respiratory Tract Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed vaccinationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine vaccination (Control) | No intervention | Not described |
| Delay vaccination (Experimental) | Experimental | Not described Receives: Behavioral: Delayed vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to influenza vaccination - Aim 1
Measured: 1 month
Physician diagnosed respiratory infection incidence - Aim 1
Measured: 6 months
Physician diagnosed injury incidence - Aim 1
Measured: 6 months
Antibody response to second hepatitis B vaccination - Aim 2
Measured: Routine group: 3 months; Delay group: 4 months
Secondary outcomes (9)
Antibody response to influenza vaccination
Measured: 4 months
Antibody response to first hepatitis B vaccination
Measured: Routine group: 1 months; Delay group: 2 months
C-reactive protein
Measured: Baseline, 1-day post vaccination and 1 month
Gene expression profiling
Measured: Baseline and 1 month
Epstein Barr Virus serostatus/antibody titre
Measured: Baseline and 1 month
Cytomegalovirus serostatus/antibody titre
Measured: Baseline and 1 month
Torque Teno Virus plasma DNA
Measured: Baseline and 1 month
Interleukin-6
Measured: Baseline and 1 month
Hair cortisol
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start19 Oct 2020
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, University of California, Los Angeles, Loughborough University, Ministry of Defence, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Neil P Walsh, PHD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780867
- Sponsor's protocol ID
- 1070/MODREC/20
- Status last verified
- Apr 2023
- First submitted
- 15 Feb 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Psychosocial and Lifestyle Factors on Immune Health and Injury Incidence During Phase One Training in UK Army Recruits
- ClinicalTrials.gov ID
- NCT04780867
- Acronym / sponsor ID
- 1070/MODREC/20
- Conditions
- Psychological, Stress, Immune Health, Vaccination, Respiratory Tract Infections, Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,188 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- University of Nottingham, University of California, Los Angeles, Loughborough University, Ministry of Defence, United Kingdom
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Routine vaccination (Control) | No intervention | – |
| Delay vaccination (Experimental) | Experimental | Behavioral: Delayed vaccination |
Who may qualify
- Ages
- 16 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Men and women aged 16-33 years enrolled in phase one British Army training
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed vaccinationFirst 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. | Behavioural | Delay vaccination (Experimental) |
Primary outcome
Antibody response to influenza vaccination - Aim 1
Time frame: 1 month
Physician diagnosed respiratory infection incidence - Aim 1
Time frame: 6 months
Physician diagnosed injury incidence - Aim 1
Time frame: 6 months
Antibody response to second hepatitis B vaccination - Aim 2
Time frame: Routine group: 3 months; Delay group: 4 months
9 secondary outcomes
Antibody response to influenza vaccination
Time frame: 4 months
Antibody response to first hepatitis B vaccination
Time frame: Routine group: 1 months; Delay group: 2 months
C-reactive protein
Time frame: Baseline, 1-day post vaccination and 1 month
Gene expression profiling
Time frame: Baseline and 1 month
Epstein Barr Virus serostatus/antibody titre
Time frame: Baseline and 1 month
Cytomegalovirus serostatus/antibody titre
Time frame: Baseline and 1 month
Torque Teno Virus plasma DNA
Time frame: Baseline and 1 month
Interleukin-6
Time frame: Baseline and 1 month
Hair cortisol
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil P Walsh, PHD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed vaccination in people with Psychological and Stress, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody response to influenza vaccination - Aim 1 (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.