The Role of Fatty Acids in Vaccine Efficacy

Tsinghua University45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Rabies Vaccination Reaction

Interventions

Arachidonic acidDIETARY_SUPPLEMENT

D3 ARA group will receive ARA capsules from the third day of the study. D6 ARA group will receive ARA capsules from the sixth day of the study

Sunflower oilDIETARY_SUPPLEMENT

The placebo group and D6 ARA group will receive sunflower oil capsules from the third day of the study. D6 ARA group will stop receiving sunflower oil capsules from the fifth day of the study.

Rabies Vaccine (Vero Cell) for Human UseBIOLOGICAL

Every participant will receive three doses of rabies vaccination.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tsinghua University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Changes of rabies virus antibody titers

specific antibody titers

Time frame: Day 6, 13, 16, 19, 26 of the study

Changes of neutralizing antibody titers

To test the ability of binding to rabies virus

Time frame: Day 6, 13, 16, 19, 26 of the study

Secondary Outcomes

serum blood fatty acid profiles

to test the change of fatty acid profiles after intervention

Time frame: Day 6, 13, 16，19 of the study

C-reactive protein

to test the potential C-reactive protein changes triggered by ARA supplementation

Time frame: Day 6, 13, 16 and 19 of the study

Routine analysis of intestinal flora: alpha diversity

The alpha diversity of microbiota in feces samples will be examined to explore the potential gut-immune response caused by intervention.

Time frame: Day 3 and day 19 of the study

Routine analysis of intestinal flora: beta diversity

The beta diversity of microbiota in feces samples will be examined to explore the potential gut-immune response caused by the intervention.

Time frame: Day 3 and day 19 of the study

Routine analysis of intestinal flora: species abundance histogram

The species abundance histogram of microbiota in feces samples will be examined to explore the potential gut-immune response caused by the intervention.

Time frame: Day 3 and day 19 of the study

Data from ClinicalTrials.gov

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