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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Sunflower oil capsules |
|
| D3 ARA group | Experimental | ARA capsules |
|
| D6 ARA group | Experimental | Sunflower oil capsules and ARA capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arachidonic acid | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of rabies virus antibody titers | specific antibody titers | Day 6, 13, 16, 19, 26 of the study |
| Changes of neutralizing antibody titers | To test the ability of binding to rabies virus | Day 6, 13, 16, 19, 26 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| serum blood fatty acid profiles | to test the change of fatty acid profiles after intervention | Day 6, 13, 16，19 of the study |
| C-reactive protein | to test the potential C-reactive protein changes triggered by ARA supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events by ARA | To examine the safety of using ARA, including allergy, gastrointestinal discomfort and others. | Day 3 to day 30 of the trial. |
| Serum triglyceride levels | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ai Zhao, Doctor | Tsinghua University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsinghua University | Beijing | Beijing Municipality | 100084 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37024944 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 9, 2025 | |
| Reset | Sep 29, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2023 | Jun 25, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2023 | Jun 25, 2023 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 9, 2025 | Sep 29, 2025 |
| ID | Term |
|---|---|
| D016718 | Arachidonic Acid |
| D000074242 | Sunflower Oil |
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D001095 | Arachidonic Acids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| Sunflower oil | 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 | Biological | Every participant will receive three doses of rabies vaccination. |
|
| Day 6, 13, 16 and 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| 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. | Day 3 and day 19 of the study |
| Days 3 and day 19 of the study. |
| Blood count: red blood cells | To evaluate the intervention safety. | tested on day 3 and day 19 of the trial. |
| Blood count: white blood cells | To evaluate the intervention safety. | tested on day 3 and day 19 of the trial. |
| Blood count: hemoglobin | To evaluate the intervention safety. | tested on day 3 and day 19 of the trial. |
| Blood count: hematocrit | To evaluate the intervention safety. | tested on day 3 and day 19 of the trial. |
| Blood count: platelets | To evaluate the intervention safety. | tested on day 3 and day 19 of the trial. |
| Anxiety | Evaluated with General Anxiety Disorder-7 items. The scores are between 0 to 21, higher scores mean a worse outcome. | tested on day 13 of the trial. |
| Depression | Evaluated with Patient Health Questionaire-9 items. The scores are between 0 to 27, higher scores mean a worse outcome. | tested on day 13 of the trial. |
| D008055 |
| Lipids |
| D005228 | Fatty Acids, Essential |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |