The Role of Fatty Acids in Vaccine Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2023-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rabies Vaccination Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo group

Sunflower oil capsules

Group Type PLACEBO_COMPARATOR

Sunflower oil

Intervention Type DIETARY_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 Use

Intervention Type BIOLOGICAL

Every participant will receive three doses of rabies vaccination.

D3 ARA group

ARA capsules

Group Type EXPERIMENTAL

Arachidonic acid

Intervention Type DIETARY_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

Rabies Vaccine (Vero Cell) for Human Use

Intervention Type BIOLOGICAL

Every participant will receive three doses of rabies vaccination.

D6 ARA group

Sunflower oil capsules and ARA capsules

Group Type EXPERIMENTAL

Arachidonic acid

Intervention Type DIETARY_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 oil

Intervention Type DIETARY_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 Use

Intervention Type BIOLOGICAL

Every participant will receive three doses of rabies vaccination.

Interventions

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Arachidonic acid

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

Intervention Type DIETARY_SUPPLEMENT

Sunflower oil

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.

Intervention Type DIETARY_SUPPLEMENT

Rabies Vaccine (Vero Cell) for Human Use

Every participant will receive three doses of rabies vaccination.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes