Back to resultsThe Role of Fatty Acids in Vaccine Efficacy
Primary Purpose
Rabies Vaccination Reaction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Arachidonic acid
Sunflower oil
Rabies Vaccine (Vero Cell) for Human Use
Sponsored by
About this trial
This is an interventional basic science trial for Rabies Vaccination Reaction focused on measuring Rabies Vaccination, Arachidonic acid, efficacy
Eligibility Criteria
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.
Sites / Locations
- Tsinghua University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo group
D3 ARA group
D6 ARA group
Arm Description
Sunflower oil capsules
ARA capsules
Sunflower oil capsules and ARA capsules
Outcomes
Primary Outcome Measures
Changes of rabies virus antibody titers
specific antibody titers
Changes of neutralizing antibody titers
To test the ability of binding to rabies virus
Secondary Outcome Measures
serum blood fatty acid profiles
to test the change of fatty acid profiles after intervention
C-reactive protein
to test the potential C-reactive protein changes triggered by ARA supplementation
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.
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.
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.
Routine analysis of intestinal flora: Lefse
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
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
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
The differential KO expression microbiota in feces samples will be analyzed to explore the potential gut-immune response caused by the intervention.
Macrogenomic sequencing difference of intestinal flora
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
The fatty acid content in feces samples will be examined to explore the change of fatty acid intake caused by the intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05987384
Brief Title
The Role of Fatty Acids in Vaccine Efficacy
Official Title
The Role of Fatty Acids in Vaccine Efficacy: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tsinghua University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies Vaccination Reaction
Keywords
Rabies Vaccination, Arachidonic acid, efficacy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Sunflower oil capsules
Arm Title
D3 ARA group
Arm Type
Experimental
Arm Description
ARA capsules
Arm Title
D6 ARA group
Arm Type
Experimental
Arm Description
Sunflower oil capsules and ARA capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Arachidonic acid
Intervention Description
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
Intervention Name(s)
Sunflower oil
Intervention Description
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
Biological
Intervention Name(s)
Rabies Vaccine (Vero Cell) for Human Use
Intervention Description
Every participant will receive three doses of rabies vaccination.
Primary Outcome Measure Information:
Title
Changes of rabies virus antibody titers
Description
specific antibody titers
Time Frame
Day 6, 13, 16, 19, 26 of the study
Title
Changes of neutralizing antibody titers
Description
To test the ability of binding to rabies virus
Time Frame
Day 6, 13, 16, 19, 26 of the study
Secondary Outcome Measure Information:
Title
serum blood fatty acid profiles
Description
to test the change of fatty acid profiles after intervention
Time Frame
Day 6, 13, 16，19 of the study
Title
C-reactive protein
Description
to test the potential C-reactive protein changes triggered by ARA supplementation
Time Frame
Day 6, 13, 16 and 19 of the study
Title
Routine analysis of intestinal flora: alpha diversity
Description
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
Title
Routine analysis of intestinal flora: beta diversity
Description
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
Title
Routine analysis of intestinal flora: species abundance histogram
Description
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
Title
Routine analysis of intestinal flora: Lefse
Description
The Lefse of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Time Frame
Day 3 and day 19 of the study
Title
Routine analysis of intestinal flora: PLS-DA
Description
The PLS-DA of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Time Frame
Day 3 and day 19 of the study
Title
Routine analysis of intestinal flora: KEGG pathway
Description
The KEGG pathway microbiota in feces samples will be analyzed to explore the potential gut-immune response caused by the intervention.
Time Frame
Day 3 and day 19 of the study
Title
Routine analysis of intestinal flora: differential KO expression
Description
The differential KO expression microbiota in feces samples will be analyzed to explore the potential gut-immune response caused by the intervention.
Time Frame
Day 3 and day 19 of the study
Title
Macrogenomic sequencing difference of intestinal flora
Description
The macrogenomic sequencing analysis of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Time Frame
Day 3 and day 19 of the study
Title
Fecal fatty acid content
Description
The fatty acid content in feces samples will be examined to explore the change of fatty acid intake caused by the intervention.
Time Frame
Day 3 and day 19 of the study
Other Pre-specified Outcome Measures:
Title
Adverse events by ARA
Description
To examine the safety of using ARA, including allergy, gastrointestinal discomfort and others.
Time Frame
Day 3 to day 30 of the trial.
Title
Serum triglyceride levels
Description
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).
Time Frame
Days 3 and day 19 of the study.
Title
Blood count: red blood cells
Description
To evaluate the intervention safety.
Time Frame
tested on day 3 and day 19 of the trial.
Title
Blood count: white blood cells
Description
To evaluate the intervention safety.
Time Frame
tested on day 3 and day 19 of the trial.
Title
Blood count: hemoglobin
Description
To evaluate the intervention safety.
Time Frame
tested on day 3 and day 19 of the trial.
Title
Blood count: hematocrit
Description
To evaluate the intervention safety.
Time Frame
tested on day 3 and day 19 of the trial.
Title
Blood count: platelets
Description
To evaluate the intervention safety.
Time Frame
tested on day 3 and day 19 of the trial.
Title
Anxiety
Description
Evaluated with General Anxiety Disorder-7 items. The scores are between 0 to 21, higher scores mean a worse outcome.
Time Frame
tested on day 13 of the trial.
Title
Depression
Description
Evaluated with Patient Health Questionaire-9 items. The scores are between 0 to 27, higher scores mean a worse outcome.
Time Frame
tested on day 13 of the trial.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai Zhao, Doctor
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
Facility Information:
Facility Name
Tsinghua University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100084
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
37024944
Citation
Shen T, Welburn SC, Sun L, Yang GJ. Progress towards dog-mediated rabies elimination in PR China: a scoping review. Infect Dis Poverty. 2023 Apr 6;12(1):30. doi: 10.1186/s40249-023-01082-3.
Results Reference
background
Learn more about this trial
The Role of Fatty Acids in Vaccine Efficacy
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