Clinical trial NCT05987384: The Role of Fatty Acids in Vaccine Efficacy
Official title: The Role of Fatty Acids in Vaccine Efficacy: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rabies Vaccination Reaction
Keywords: Rabies Vaccination
Arachidonic acid
efficacy
Lead sponsor: Tsinghua University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1）18-45 years old;
* 2）BMI 18.5-24.9 kg/m2;
* 3）Have not received rabies vaccination.

Exclusion Criteria:

* 1) Those who have severe disorders of abnormal lipid metabolism;
* 2) Those who have used lipid-lowering drugs, weight loss drugs, and insulin drugs in the past three months;
* 3) Those who have received other vaccines in the past three months;
* 4) Those who have used probiotics or prebiotics in the past three months;
* 5) Those who have used steroids and immunosuppressants, other hormonal drugs in the past year;
* 6) Those with immunodeficiency diseases;
* 7) Those with a history of severe vaccine allergies;
* 8) Those who have disorders of liver and kidney metabolism;
* 9) Those who have had fever, cold, severe diarrhea and other diseases in the past month.
* 10) Smokers in the last year.

Primary outcomes:
measure: Changes of rabies virus antibody titers
timeFrame: Day 6, 13, 16, 19, 26 of the study
measure: Changes of neutralizing antibody titers
timeFrame: Day 6, 13, 16, 19, 26 of the study
Secondary outcomes:
measure: serum blood fatty acid profiles
timeFrame: Day 6, 13, 16，19 of the study
measure: C-reactive protein
timeFrame: Day 6, 13, 16 and 19 of the study
measure: Routine analysis of intestinal flora: alpha diversity
timeFrame: Day 3 and day 19 of the study
measure: Routine analysis of intestinal flora: beta diversity
timeFrame: Day 3 and day 19 of the study
measure: Routine analysis of intestinal flora: species abundance histogram
timeFrame: Day 3 and day 19 of the study
measure: Routine analysis of intestinal flora: Lefse
timeFrame: Day 3 and day 19 of the study
measure: Routine analysis of intestinal flora: PLS-DA
timeFrame: Day 3 and day 19 of the study
measure: Routine analysis of intestinal flora: KEGG pathway
timeFrame: Day 3 and day 19 of the study
measure: Routine analysis of intestinal flora: differential KO expression
timeFrame: Day 3 and day 19 of the study
measure: Macrogenomic sequencing difference of intestinal flora
timeFrame: Day 3 and day 19 of the study
measure: Fecal fatty acid content
timeFrame: Day 3 and day 19 of the study
Other outcomes:
measure: Adverse events by ARA
timeFrame: Day 3 to day 30 of the trial.
measure: Serum triglyceride levels
timeFrame: Days 3 and day 19 of the study.
measure: Blood count: red blood cells
timeFrame: tested on day 3 and day 19 of the trial.
measure: Blood count: white blood cells
timeFrame: tested on day 3 and day 19 of the trial.
measure: Blood count: hemoglobin
timeFrame: tested on day 3 and day 19 of the trial.
measure: Blood count: hematocrit
timeFrame: tested on day 3 and day 19 of the trial.
measure: Blood count: platelets
timeFrame: tested on day 3 and day 19 of the trial.
measure: Anxiety
timeFrame: tested on day 13 of the trial.
measure: Depression
timeFrame: tested on day 13 of the trial.
Locations:
city: Beijing
country: China
facility: Tsinghua University
state: Beijing
Study officials:
affiliation: Tsinghua University
name: Ai Zhao, Doctor
role: STUDY_CHAIR
References:
citation: Shen T, Welburn SC, Sun L, Yang GJ. Progress towards dog-mediated rabies elimination in PR China: a scoping review. Infect Dis Poverty. 2023 Apr 6;12(1):30. doi: 10.1186/s40249-023-01082-3.