The Role of Fatty Acids in Vaccine Efficacy

Not Applicable

Completed

• Conditions: Rabies Vaccination Reaction
• Interventions: Dietary Supplement: Sunflower oil; Dietary Supplement: Arachidonic acid; Biological: Rabies Vaccine (Vero Cell) for Human Use

• Registration Number: NCT05987384
• Lead Sponsor: Tsinghua University

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.

Study Timeline

• Study Start: 2023-05-03
• Study First Submitted: 2023-06-08
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D6 ARA group	Rabies Vaccine (Vero Cell) for Human Use	Sunflower oil capsules and ARA capsules
Placebo group	Sunflower oil	Sunflower oil capsules
Placebo group	Rabies Vaccine (Vero Cell) for Human Use	Sunflower oil capsules
D3 ARA group	Rabies Vaccine (Vero Cell) for Human Use	ARA capsules
D6 ARA group	Arachidonic acid	Sunflower oil capsules and ARA capsules
D3 ARA group	Arachidonic acid	ARA capsules
D6 ARA group	Sunflower oil	Sunflower oil capsules and ARA capsules

Primary Outcome Measures

Name	Time	Method
Changes of rabies virus antibody titers	Day 6, 13, 16, 19, 26 of the study	specific antibody titers
Changes of neutralizing antibody titers	Day 6, 13, 16, 19, 26 of the study	To test the ability of binding to rabies virus

Secondary Outcome Measures

Name	Time	Method
Routine analysis of intestinal flora: species abundance histogram	Day 3 and day 19 of the study	The species abundance histogram of microbiota in feces samples will be examined to explore the potential gut-immune response caused by the intervention.
serum blood fatty acid profiles	Day 6, 13, 16，19 of the study	to test the change of fatty acid profiles after intervention
C-reactive protein	Day 6, 13, 16 and 19 of the study	to test the potential C-reactive protein changes triggered by ARA supplementation
Routine analysis of intestinal flora: KEGG pathway	Day 3 and day 19 of the study	The KEGG pathway microbiota in feces samples will be analyzed to explore the potential gut-immune response caused by the intervention.
Routine analysis of intestinal flora: differential KO expression	Day 3 and day 19 of the study	The differential KO expression microbiota in feces samples will be analyzed to explore the potential gut-immune response caused by the intervention.
Routine analysis of intestinal flora: beta diversity	Day 3 and day 19 of the study	The beta diversity of microbiota in feces samples will be examined to explore the potential gut-immune response caused by the intervention.
Routine analysis of intestinal flora: PLS-DA	Day 3 and day 19 of the study	The PLS-DA of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Routine analysis of intestinal flora: Lefse	Day 3 and day 19 of the study	The Lefse of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Routine analysis of intestinal flora: alpha diversity	Day 3 and day 19 of the study	The alpha diversity of microbiota in feces samples will be examined to explore the potential gut-immune response caused by intervention.
Macrogenomic sequencing difference of intestinal flora	Day 3 and day 19 of the study	The macrogenomic sequencing analysis of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Fecal fatty acid content	Day 3 and day 19 of the study	The fatty acid content in feces samples will be examined to explore the change of fatty acid intake caused by the intervention.

Trial Locations

Locations (1)

Tsinghua University; 🇨🇳 Beijing, Beijing, China