Clifford Craig Vaccine Trial Centre: Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Vaccine Challenge in the Elderly
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood
研究概览
简要总结
Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult control subjects (30-50 years).
详细描述
This prospective randomised study aims to investigate the heterologous immunological effects of DTP and seasonal influenza (Flu) vaccination in an elderly Tasmanian population and healthy adults. The study will assess whether prior or concurrent administration of DTP with seasonal Flu vaccination affects generalised inflammation / immune homeostasis and gene expression, with a particular focus of inflammation reactive cells. It will also analyse for effects of DTP on the induction of vaccine-specific immunity to seasonal influenza vaccination (antibodies and cellular). Volunteers will be randomised to one of three vaccine groups and serial blood samples taken for immunological assays for up to 30 weeks.
The study is exploratory and will investigate vaccine effects on multiple immune parameters.
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
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two study groups 30-50 years old >65 years old
排除标准
- •Unwell on day of vaccination
- •Temperature >38°C
- •Active cancer
- •Active autoimmune disease
- •Diabetes mellitus
- •Taking immunosuppressive drugs including steroids
- •Any vaccination in last 3 months
- •DT or DTaP vaccination in the last year
- •Known allergy or contraindication to influenza or DTaP vaccination
- •Pregnant or breastfeeding
研究组 & 干预措施
Group 1
Diphtheria-tetanus-acellular pertussis vaccine administered day 0, followed by seasonal influenza vaccination four weeks later. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week, 4 weeks, 4 weeks + 24 hours, 5 weeks, 8 weeks and 30 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
干预措施: Diphtheria-tetanus-acellular pertussis vaccine (Biological)
Group 2
Seasonal influenza vaccine administered on day 0, to be offered DTP vaccine at week 26. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
干预措施: Diphtheria-tetanus-acellular pertussis vaccine (Biological)
Group 3
Seasonal influenza vaccine and DTP vaccine administered together on day 0. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
干预措施: Diphtheria-tetanus-acellular pertussis vaccine (Biological)
Group 3
Seasonal influenza vaccine and DTP vaccine administered together on day 0. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
干预措施: Seasonal influenza vaccine (Biological)
Group 2
Seasonal influenza vaccine administered on day 0, to be offered DTP vaccine at week 26. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week 1, 4 weeks and 26 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
干预措施: Seasonal influenza vaccine (Biological)
Group 1
Diphtheria-tetanus-acellular pertussis vaccine administered day 0, followed by seasonal influenza vaccination four weeks later. Blood testing to occur day 0 (prior to vaccine administration), 24 hours, 1 week, 4 weeks, 4 weeks + 24 hours, 5 weeks, 8 weeks and 30 weeks. Stool samples to be taken at day 0 and 1 week post-vaccination.
干预措施: Seasonal influenza vaccine (Biological)
结局指标
主要结局
Number of inflammation reactive TNFR2+ regulatory T cells per mL of blood
时间窗: 24 hours, 1 week, 4 weeks and 26 weeks
Change over time in different vaccine groups of Tregs measured by flow cytometry.
次要结局
- Whole human genome transcription profile by next generation sequencing in log2 expression levels(24 hours)
- Influenza-specific antibody titres to seasonal influenza vaccination(4 weeks and 26 weeks)
- Pro-inflammatory (TNF) to anti-inflammatory (IL-10) cytokine ratio in stimulated blood in pg/mL(24 hours, 1 week, 4 weeks and 26 weeks)
- Influenza-specific IFN-g CD4 T cell responses to seasonal influenza vaccination in pg/mL(4 weeks and 26 weeks)