NCT05987384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

June 8, 2023

Last Update Submit

August 8, 2023

Conditions

Rabies Vaccination Reaction

Keywords

Rabies VaccinationArachidonic acidefficacy

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (11)

  • serum blood fatty acid profiles

    Day 6, 13, 16，19 of the study

  • C-reactive protein

    Day 6, 13, 16 and 19 of the study

  • Routine analysis of intestinal flora: alpha diversity

    Day 3 and day 19 of the study

  • Routine analysis of intestinal flora: beta diversity

    Day 3 and day 19 of the study

  • Routine analysis of intestinal flora: species abundance histogram

    Day 3 and day 19 of the study

  • +6 more secondary outcomes

Other Outcomes (9)

  • Adverse events by ARA

    Day 3 to day 30 of the trial.

  • Serum triglyceride levels

    Days 3 and day 19 of the study.

  • Blood count: red blood cells

    tested on day 3 and day 19 of the trial.

  • +6 more other outcomes

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Sunflower oil capsules

Dietary Supplement: Sunflower oilBiological: Rabies Vaccine (Vero Cell) for Human Use

D3 ARA group

EXPERIMENTAL

ARA capsules

Dietary Supplement: Arachidonic acidBiological: Rabies Vaccine (Vero Cell) for Human Use

D6 ARA group

EXPERIMENTAL

Sunflower oil capsules and ARA capsules

Dietary Supplement: Arachidonic acidDietary Supplement: Sunflower oilBiological: Rabies Vaccine (Vero Cell) for Human Use

Interventions

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

D3 ARA groupD6 ARA group
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.

D6 ARA groupPlacebo group
Rabies Vaccine (Vero Cell) for Human UseBIOLOGICAL

Every participant will receive three doses of rabies vaccination.

D3 ARA groupD6 ARA groupPlacebo group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ）18-45 years old;
  • ）BMI 18.5-24.9 kg/m2;
  • ）Have not received rabies vaccination.

You may not qualify if:

  • \) Those who have severe disorders of abnormal lipid metabolism;
  • \) Those who have used lipid-lowering drugs, weight loss drugs, and insulin drugs in the past three months;
  • \) Those who have received other vaccines in the past three months;
  • \) Those who have used probiotics or prebiotics in the past three months;
  • \) Those who have used steroids and immunosuppressants, other hormonal drugs in the past year;
  • \) Those with immunodeficiency diseases;
  • \) Those with a history of severe vaccine allergies;
  • \) Those who have disorders of liver and kidney metabolism;
  • \) Those who have had fever, cold, severe diarrhea and other diseases in the past month.
  • \) Smokers in the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsinghua University

Beijing, Beijing Municipality, 100084, China

Location

Related Publications (1)

  • 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.

    PMID: 37024944BACKGROUND

MeSH Terms

Interventions

Arachidonic AcidSunflower OilRabies Vaccines

Intervention Hierarchy (Ancestors)

Arachidonic AcidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, EssentialPlant OilsPlant PreparationsBiological ProductsComplex MixturesViral VaccinesVaccines

Study Officials

  • Ai Zhao, Doctor

    Tsinghua University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 8, 2023

First Posted

August 14, 2023

Study Start

May 3, 2023

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)