Tsinghua University
Beijing, Beijing Municipality, 100084, China
Completed
NCT Number: NCT05987384
The Role of Fatty Acids in Vaccine Efficacy
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Arachidonic acid
Dietary SupplementD3 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
Dietary SupplementThe 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
BiologicalEvery participant will receive three doses of rabies vaccination.
Primary outcomes
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Changes of rabies virus antibody titers
Time frame: Day 6, 13, 16, 19, 26 of the study
specific antibody titers
-
Changes of neutralizing antibody titers
Time frame: Day 6, 13, 16, 19, 26 of the study
To test the ability of binding to rabies virus
Secondary outcomes
-
serum blood fatty acid profiles
Time frame: Day 6, 13, 16，19 of the study
to test the change of fatty acid profiles after intervention
-
C-reactive protein
Time frame: 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: alpha diversity
Time frame: 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.
-
Routine analysis of intestinal flora: beta diversity
Time frame: 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: species abundance histogram
Time frame: 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.
-
Routine analysis of intestinal flora: Lefse
Time frame: 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: PLS-DA
Time frame: 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: KEGG pathway
Time frame: 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
Time frame: 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.
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Macrogenomic sequencing difference of intestinal flora
Time frame: 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
Time frame: 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.
Other outcomes
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Adverse events by ARA
Time frame: Day 3 to day 30 of the trial.
To examine the safety of using ARA, including allergy, gastrointestinal discomfort and others.
-
Serum triglyceride levels
Time frame: Days 3 and day 19 of the study.
To examine the changes of blood lipids in blood after intervention and evaluate the intervention safety. The spacific measurements include: Triglycerides (TG), high-density lipoprotein cholesterol (HDL-CHO), low-density lipoprotein cholesterol (LDL-C), and total cholesterol (TC).
-
Blood count: red blood cells
Time frame: tested on day 3 and day 19 of the trial.
To evaluate the intervention safety.
-
Blood count: white blood cells
Time frame: tested on day 3 and day 19 of the trial.
To evaluate the intervention safety.
-
Blood count: hemoglobin
Time frame: tested on day 3 and day 19 of the trial.
To evaluate the intervention safety.
-
Blood count: hematocrit
Time frame: tested on day 3 and day 19 of the trial.
To evaluate the intervention safety.
-
Blood count: platelets
Time frame: tested on day 3 and day 19 of the trial.
To evaluate the intervention safety.
-
Anxiety
Time frame: tested on day 13 of the trial.
Evaluated with General Anxiety Disorder-7 items. The scores are between 0 to 21, higher scores mean a worse outcome.
-
Depression
Time frame: tested on day 13 of the trial.
Evaluated with Patient Health Questionaire-9 items. The scores are between 0 to 27, higher scores mean a worse outcome.
Sponsors and collaborators
Lead sponsor
Tsinghua University
Other
Registry information
Official study title
The Role of Fatty Acids in Vaccine Efficacy: A Randomized Controlled Clinical Trial
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Aug 14, 2023
- Registry last updated
- Aug 14, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.