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Influenza Vaccine ResponseEOSIIVE-RCTNCT06827873

Effect of Oral Supplements for Influenza Vaccine Response

A study testing ARA (Arachidonic Acid) Supplementation, TUDCA (Tauroursodeoxycholic Acid) Supplementation and Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine in people with Influenza Vaccine Response, run by Tsinghua University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this clinical trial is to explore the efficacy of fatty acid and bile acid based supplements on enhancing influenza vaccine immune response in adults aged 60-70 years. The objectives of this study are: 1. Read more about this study

Who is it for?
Ages 60 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Influenza Vaccine Response
What is being tested?
ARA (Arachidonic Acid) Supplementation, TUDCA (Tauroursodeoxycholic Acid) Supplementation and Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteChina
Study dates
Feb 2025to Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 60-70 years old
  • Body Mass Index (BMI) 18.5-26.9 kg/m²
  • No influenza vaccination in the past year
  • Able to understand and sign the informed consent form, and capable of completing the full follow-up process

Who cannot join

  • Severe lipid metabolism disorders
  • Use of lipid-lowering medications, weight loss drugs, or insulin within the past three months
  • Vaccination with other vaccines within the past three months
  • Use of probiotics or prebiotics within the past three months
  • Use of steroids, immunosuppressants, or other hormonal medications within the past year
  • Immunodeficiency diseases
Show all 13Show fewer
  • Severe vaccine allergy history
  • Liver or kidney metabolic disorders
  • Occurrence of fever, common cold, severe diarrhea, or other diseases within the past month
  • Poorly controlled chronic diseases (such as blood pressure, blood sugar)
  • Intake of influenza antiviral drugs within the past two weeks
  • Cognitive function impairment
  • Planning to undergo surgery in the near future

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ai Zhao, Doctor contact

+86 13811131994

aizhao18@mail.tsinghua.edu.cn

China1 site

  • Tsinghua University

    Beijing, Beijing Municipality, 100084

    Ai Zhao, Doctor, +86 13811131994, aizhao18@mail.tsinghua.edu.cn

    Litian Hou, Master, +86 17888846812, hlt24@mails.tsinghua.edu.cn

Other trials in China

About this study

Official title: Effect of Oral Supplement Intervention on Influenza Vaccine Efficacy: a Randomized Controlled Clinical Trial

The aim of this clinical trial is to explore the efficacy of fatty acid and bile acid based supplements on enhancing influenza vaccine immune response in adults aged 60-70 years. The objectives of this study are:

  1. To explore the efficacy of fatty acid and bile acid based supplements on enhancing flu vaccine immune response.
  2. To evaluate the safety of fatty acid and bile acid use in elders.
  3. To explore the potential role of microbiota in regulating immune response.
Read more

This study will conduct a randomized clinical trial to compare the efficacy of fatty acid / bile acid (Tauro Ursodesoxy Cholic Acid, TUDCA)supplements on enhancing vaccine immune response. The antibody's titer and safety indicators after influenza vaccination will be evaluated. Study process are:

  1. Participants will be required to intake the assigned supplement or placebo daily for 25 days;
  2. Receive a influenza vaccine on day 4;
  3. Provide blood samples three times and stool samples twice at base line and endpoint respectively;
  4. The antibody's titer and safety indicators will be analyzed and compared among groups.

This study aims to establish a theoretical foundation for utilizing nutritional strategies to enhance vaccine-induced immune responses and to provide a scientific framework for developing oral vaccine boosters.

Read the detailed description

Influenza virus infection presents a significant global health challenge, particularly threatening the elderly population due to immunosenescence. The immune response to influenza vaccination involves a complex series of events: after vaccination, hemagglutination inhibition antibody titers peak around day 14, accompanied by the production of neutralizing antibodies and other specific antibodies. This immune response gradually stabilizes to a post-response baseline level as immune memory establishes.

The age-related decline in immune function manifests through multiple mechanisms,including: reduced production of naive T cells; decreased diversity of T cell repertoire; compromised B cell function, altered cytokine production profiles which all diminished vaccine response efficacy.

Recent advances in immunometabolism have revealed the crucial role of specific fatty acids in immune system modulation. Our preliminary explorations found that，short-term Arachidonic Acid（AA）intervention could significantly reduce the time required for antibody production and enhance its levels following rabies vaccination. We also noticed that the serum Tauro Ursodesoxy Cholic Acid (TUDCA) was elevated in the intervention group. However, the related mechanism is still not clear.

The theoretical framework integrates nutritional immunology with classical vaccinology, focusing on the metabolic interaction between dietary fatty acids and immune cell function. This approach is particularly relevant for the elderly population, where reduced vaccine responsiveness due to immunosenescence presents a significant challenge in achieving optimal vaccine protection.

Being tested
ARA (Arachidonic Acid) Supplementation, TUDCA (Tauroursodeoxycholic Acid) Supplementation, Placebo Supplementation, Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
Keywords
Vaccine Efficacy, Elderly Immunity, Fatty Acid Supplementation, Gut Microbiota, Randomized Controlled Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARA (Arachidonic Acid) SupplementationDietary supplement

    Also called AA, 5,8,11,14-Eicosatetraenoic acid, C20:4

    Oral ARA (Arachidonic Acid) dietary supplement capsules, dosage 1000 mg/person/day. Capsule composition includes: C14:0 (0.15%), C16:0 (6.08%), C16:1 (0.15%), C18:0 (4.57%), C18:1 (19.65%), C18:2 (38.46%), C18:3 (0.87%), C20:0 (0.50%), C20:3 (2.00%), C20:4 (18.66%), C22:0 (1.81%), C24:0 (4.05%). Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.

  • TUDCA (Tauroursodeoxycholic Acid) SupplementationDrug

    Oral Double Wood brand TUDCA (Tauroursodeoxycholic Acid) dietary supplement capsules, dosage 1000 mg/person/day. Capsules primarily contain TUDCA, with 500 mg per serving (two capsules), other ingredients include gelatin and rice powder. Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.

  • Placebo SupplementationDietary supplement

    Also called Placebo Capsules

    Oral placebo capsules identical in appearance and smell, dosage 1000 mg/person/day. Placebo capsule composition includes: C14:0 (0.09%), C16:0 (6.12%), C16:1 (0.03%), C18:0 (3.50%), C18:1 (28.06%), C18:2 (59.40%), C20:0 (0.27%), C22:0 (0.76%), C24:0 (0.26%). Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue taking placebo until Day 24.

  • Shanghai Biological Quadrivalent Influenza Virus Inactivated VaccineBiological

    Also called Quadrivalent Influenza Vaccine

    Administer Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine, produced by Shanghai Biological Products Research Institute Co., Ltd. , specification 0.5ml/dose, containing 15.0 μg hemagglutinin (for each influenza virus strain), suitable for intramuscular injection in individuals 6 months and older. Administer one dose to all study participants on Day 3. Closely observe and record any potential adverse reactions after vaccination.

Study groups in NCT06827873
Study groupRoleWhat they receive
ARA (Arachidonic Acid) Supplement GroupExperimentalParticipants will take 1000 mg of ARA (Arachidonic Acid) dietary supplement capsules daily. Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.
Receives: Dietary Supplement: ARA (Arachidonic Acid) Supplementation; Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
TUDCA (Tauroursodeoxycholic acid) Supplement GroupExperimentalParticipants will take 1000 mg of TUDCA (Tauroursodeoxycholic acid) dietary supplement capsules daily. Capsules primarily contain TUDCA, with 500 mg per serving (two capsules). Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.
Receives: Drug: TUDCA (Tauroursodeoxycholic Acid) Supplementation; Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
Placebo Comparator GroupPlacebo comparatorParticipants will take 1000 mg of placebo capsules identical in appearance and smell. Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue taking placebo until Day 24.
Receives: Dietary Supplement: Placebo Supplementation; Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Specific Antibody Levels and Neutralizing Antibody Responses to Influenza Vaccine

    By detecting serum neutralizing and specific antibody levels on Day 13 and Day 24, evaluate the impact of different dietary supplements on influenza vaccine immune responses in elderly individuals. Focus primarily on changes in antibody titers to determine whether dietary supplementation can enhance vaccine immunogenicity.

    Measured: Day 13 and Day 24

Secondary outcomes (3)

  1. Changes in Inflammatory Markers

    Measure serum levels of inflammatory factors such as IL-1, IL-2, IL-6, IL-8, IL-10, IL-17 to assess the potential modulatory effect of dietary supplementation on inflammatory responses.

    Measured: Day 0 and Day 24

  2. Gut Microbiota Composition Changes

    Analyze intestinal microbiota structure and metabolomics changes through fecal samples to explore the impact of dietary supplementation on gut microecology, including:

    1. Alpha diversity analysis (Shannon index, Chao1 index, observed species)
    2. Beta diversity analysis (UniFrac distance, Bray-Curtis dissimilarity)
    3. Microbial species composition and relative abundance changes
    4. Key microbiota (such as Bacteroidetes, Actinobacteria) abundance analysis
    5. Metabolic pathway changes, including KEGG functional pathway prediction and microbiota-related immune metabolic pathways

    Measured: Day 0 and Day 24

  3. Metabolomics Analysis

    Perform non-targeted metabolomics detection to evaluate the impact of dietary supplementation on human metabolic levels, including lipid profiles, liver and kidney function indicators.

    Measured: Day 0, Day 13 and Day 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Forty-five adults aged 60-70 years are randomly assigned in equal numbers (n=15 per group) to three parallel groups: two intervention groups receiving different supplements(arachidonic acid and TUDCA) and one control group receiving placebo. The intervention period lasts 25 days, from Day 0 to Day 24. Triple-blinding is implemented to ensure that both participants and investigators are unaware of group assignments.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827873
Sponsor's protocol ID
THU01-20240201
Acronym
EOSIIVE-RCT
Status last verified
Feb 2025
First submitted
10 Feb 2025
Last updated
14 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sainz T, Casas I, Gonzalez-Esguevillas M, Escosa-Garcia L, Munoz-Fernandez MA, Prieto L, Gosalbes MJ, Jimenez-Hernandez N, Ramos JT, Navarro ML, Mellado MJ, Serrano-Villar S, Calvo C. Nutritional Supplementation to Increase Influenza Vaccine Response in Children Living With HIV: A Pilot Clinical Trial. Front Pediatr. 2022 Jul 19;10:919753. doi: 10.3389/fped.2022.919753. eCollection 2022.

    PubMed 35928688

  • D'Onofrio V, Porrez S, Jacobs B, Alhatemi A, De Boever F, Waerlop G, Michels E, Vanni F, Manenti A, Leroux-Roels G, Platenburg PP, Hilgers L, Leroux-Roels I. Safety and Immunogenicity of a Carbohydrate Fatty Acid Monosulphate Ester Adjuvant Combined with a Low-Dose Quadrivalent Split-Virion Inactivated Influenza Vaccine: A Randomised, Observer-Blind, Active-Controlled, First-in-Human, Phase 1 Study. Vaccines (Basel). 2024 Sep 10;12(9):1036. doi: 10.3390/vaccines12091036.

    PubMed 39340066

  • Chou CH, Mohanty S, Kang HA, Kong L, Avila-Pacheco J, Joshi SR, Ueda I, Devine L, Raddassi K, Pierce K, Jeanfavre S, Bullock K, Meng H, Clish C, Santori FR, Shaw AC, Xavier RJ. Metabolomic and transcriptomic signatures of influenza vaccine response in healthy young and older adults. Aging Cell. 2022 Sep;21(9):e13682. doi: 10.1111/acel.13682. Epub 2022 Aug 23.

    PubMed 35996998

Questions about this trial

What is this clinical trial studying?

A study testing ARA (Arachidonic Acid) Supplementation, TUDCA (Tauroursodeoxycholic Acid) Supplementation and Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine in people with Influenza Vaccine Response, 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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ai Zhao, Doctor (+86 13811131994, aizhao18@mail.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specific Antibody Levels and Neutralizing Antibody Responses to Influenza Vaccine (time frame: Day 13 and Day 24). 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 NCT06827873, which also lists 3 linked publications.

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 Feb 2025.

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