The Influence of Psychosocial and Lifestyle Factors on Immune Health and Injury Incidence During Phase One Training in UK Army Recruits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,188
- 试验地点
- 2
- 主要终点
- Antibody response to second hepatitis B vaccination - Aim 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 33 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 16-33 years enrolled in phase one British Army training
排除标准
- 未提供
研究组 & 干预措施
Delay vaccination (Experimental)
干预措施: Delayed vaccination (Behavioral)
Routine vaccination (Control)
结局指标
主要结局
Antibody response to second hepatitis B vaccination - Aim 2
时间窗: Routine group: 3 months; Delay group: 4 months
Antibody response to influenza vaccination - Aim 1
时间窗: 1 month
Physician diagnosed injury incidence - Aim 1
时间窗: 6 months
Physician diagnosed respiratory infection incidence - Aim 1
时间窗: 6 months
次要结局
- Cytomegalovirus serostatus/antibody titre(Baseline and 1 month)
- Interleukin-6(Baseline and 1 month)
- Hair cortisol(Baseline)
- 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)
- Torque Teno Virus plasma DNA(Baseline and 1 month)
- Antibody response to influenza vaccination(4 months)
- Antibody response to first hepatitis B vaccination(Routine group: 1 months; Delay group: 2 months)