NCT05987384

The Role of Fatty Acids in Vaccine Efficacy

The Role of Fatty Acids in Vaccine Efficacy: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Tsinghua University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rabies Vaccination Reaction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
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.
BIOLOGICAL	Rabies Vaccine (Vero Cell) for Human Use	Every participant will receive three doses of rabies vaccination.

Timeline

• Start date: 2023-05-03
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: China