The Role of Fatty Acids in Vaccine Efficacy: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes of rabies virus antibody titers
研究概览
简要总结
This study intends to use a randomized controlled trial design to vaccinate all participants against rabies and perform ARA interventions during vaccination to test the efficacy, safety, and intestinal flora of each group after immunization.
详细描述
Rabies is an acute zoonotic infectious disease caused by central nervous system invasion by rabies virus. At present, there is still a lack of effective treatment, and once clinical symptoms appear, it is almost 100% fatal. Rabies vaccination within 24 hours of exposure may reduce the incidence of rabies. Pre-exposure prophylaxis is also effective, and the current recommended pre-exposure vaccination program in China is 0 days, 7th day, 21st days.
The health of the human body is inseparable from various nutrients. There are studies suggesting that arachidonic acid(ARA) has an immunomodulatory effect, but there is limited evidence for its effect on vaccines. Therefore, this study will explore the effects of nutritional supplements on the effectiveness of rabies vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1）18-45 years old;
- •2）BMI 18.5-24.9 kg/m2;
- •3）Have not received rabies vaccination.
排除标准
- •Those who have severe disorders of abnormal lipid metabolism;
- •Those who have used lipid-lowering drugs, weight loss drugs, and insulin drugs in the past three months;
- •Those who have received other vaccines in the past three months;
- •Those who have used probiotics or prebiotics in the past three months;
- •Those who have used steroids and immunosuppressants, other hormonal drugs in the past year;
- •Those with immunodeficiency diseases;
- •Those with a history of severe vaccine allergies;
- •Those who have disorders of liver and kidney metabolism;
- •Those who have had fever, cold, severe diarrhea and other diseases in the past month.
- •Smokers in the last year.
结局指标
主要结局
Changes of rabies virus antibody titers
时间窗: Day 6, 13, 16, 19, 26 of the study
specific antibody titers
Changes of neutralizing antibody titers
时间窗: Day 6, 13, 16, 19, 26 of the study
To test the ability of binding to rabies virus
次要结局
- Routine analysis of intestinal flora: species abundance histogram(Day 3 and day 19 of the study)
- serum blood fatty acid profiles(Day 6, 13, 16，19 of the study)
- C-reactive protein(Day 6, 13, 16 and 19 of the study)
- Routine analysis of intestinal flora: KEGG pathway(Day 3 and day 19 of the study)
- Routine analysis of intestinal flora: differential KO expression(Day 3 and day 19 of the study)
- Routine analysis of intestinal flora: beta diversity(Day 3 and day 19 of the study)
- Routine analysis of intestinal flora: PLS-DA(Day 3 and day 19 of the study)
- Routine analysis of intestinal flora: Lefse(Day 3 and day 19 of the study)
- Routine analysis of intestinal flora: alpha diversity(Day 3 and day 19 of the study)
- Macrogenomic sequencing difference of intestinal flora(Day 3 and day 19 of the study)
- Fecal fatty acid content(Day 3 and day 19 of the study)
研究者
Ai Zhao
Assistant Professor
Tsinghua University