Rabies Vaccination ReactionNCT05987384
The Role of Fatty Acids in Vaccine Efficacy
A study testing Arachidonic acid, Sunflower oil and Rabies Vaccine (Vero Cell) for Human Use in people with Rabies Vaccination Reaction, run by Tsinghua University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Vaccination Reaction
- What is being tested?
- Arachidonic acid, Sunflower oil and Rabies Vaccine (Vero Cell) for Human Use
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1）18-45 years old;
- 2）BMI 18.5-24.9 kg/m2;
- 3）Have not received rabies vaccination.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Fatty Acids in Vaccine Efficacy: A Randomized Controlled Clinical Trial
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.
Read the 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
- Being tested
- Arachidonic acid, Sunflower oil, Rabies Vaccine (Vero Cell) for Human Use
- Keywords
- Rabies Vaccination, Arachidonic acid, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arachidonic acidDietary 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 oilDietary 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 UseBiological
Every participant will receive three doses of rabies vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Sunflower oil capsules Receives: Dietary Supplement: Sunflower oil; Biological: Rabies Vaccine (Vero Cell) for Human Use |
| D3 ARA group | Experimental | ARA capsules Receives: Dietary Supplement: Arachidonic acid; Biological: Rabies Vaccine (Vero Cell) for Human Use |
| D6 ARA group | Experimental | Sunflower oil capsules and ARA capsules Receives: Dietary Supplement: Arachidonic acid; Dietary Supplement: Sunflower oil; Biological: Rabies Vaccine (Vero Cell) for Human Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of rabies virus antibody titers
specific antibody titers
Measured: Day 6, 13, 16, 19, 26 of the study
Changes of neutralizing antibody titers
To test the ability of binding to rabies virus
Measured: Day 6, 13, 16, 19, 26 of the study
Secondary outcomes (11)
serum blood fatty acid profiles
to test the change of fatty acid profiles after intervention
Measured: Day 6, 13, 16，19 of the study
C-reactive protein
to test the potential C-reactive protein changes triggered by ARA supplementation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 3 and day 19 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 May 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rabies Vaccination ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai Zhao, Tsinghua University
- Investigators
- Ai Zhao, Doctor, Study chair, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987384
- Sponsor's protocol ID
- 20220081
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37024944
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fatty Acids in Vaccine Efficacy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05987384
- Acronym / sponsor ID
- 20220081
- Conditions
- Rabies Vaccination Reaction
- Keywords
- Rabies Vaccination, Arachidonic acid, efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Sunflower oil, Biological: Rabies Vaccine (Vero Cell) for Human UseSunflower oil capsules |
| D3 ARA group | Experimental | Dietary Supplement: Arachidonic acid, Biological: Rabies Vaccine (Vero Cell) for Human UseARA capsules |
| D6 ARA group | Experimental | Dietary Supplement: Arachidonic acid, Dietary Supplement: Sunflower oil, Biological: Rabies Vaccine (Vero Cell) for Human UseSunflower oil capsules and ARA capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1）18-45 years old;
- 2）BMI 18.5-24.9 kg/m2;
- 3）Have not received rabies vaccination.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arachidonic acidD3 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 | D3 ARA group, D6 ARA group |
| Sunflower oilThe 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. | Dietary supplement | D6 ARA group, Placebo group |
| Rabies Vaccine (Vero Cell) for Human UseEvery participant will receive three doses of rabies vaccination. | Biological | D3 ARA group, D6 ARA group, Placebo group |
Primary outcome
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
11 secondary outcomes
serum blood fatty acid profiles
Time frame: Day 6, 13, 16，19 of the study
C-reactive protein
Time frame: Day 6, 13, 16 and 19 of the study
Routine analysis of intestinal flora: alpha diversity
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: beta diversity
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: species abundance histogram
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: Lefse
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: PLS-DA
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: KEGG pathway
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: differential KO expression
Time frame: Day 3 and day 19 of the study
Macrogenomic sequencing difference of intestinal flora
Time frame: Day 3 and day 19 of the study
Fecal fatty acid content
Time frame: Day 3 and day 19 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 37024944Shen 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ai Zhao, Doctor study chair
Tsinghua University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arachidonic acid, Sunflower oil and Rabies Vaccine (Vero Cell) for Human Use in people with Rabies Vaccination Reaction, run by Tsinghua University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of rabies virus antibody titers (time frame: Day 6, 13, 16, 19, 26 of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.