NCT04780867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

October 5, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

February 15, 2021

Last Update Submit

October 4, 2023

Conditions

PsychologicalStressImmune HealthVaccinationRespiratory Tract InfectionsInjury

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • Antibody response to influenza vaccination

    4 months

  • 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

  • Epstein Barr Virus serostatus/antibody titre

    Baseline and 1 month

  • +4 more secondary outcomes

Study Arms (2)

Routine vaccination (Control)

NO INTERVENTION

Delay vaccination (Experimental)

EXPERIMENTAL
Behavioral: Delayed vaccination

Interventions

Delayed vaccinationBEHAVIORAL

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.

Delay vaccination (Experimental)

Eligibility Criteria

Age16 Years - 33 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Men and women aged 16-33 years enrolled in phase one British Army training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infantry Training Centre

Catterick, North Yorkshire, DL9 3PS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsWounds and Injuries

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Neil P Walsh, PHD

    Liverpool John Moores University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

March 4, 2021

Study Start

October 19, 2020

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

October 5, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)