Description of the Immune Response to Yellow Fever Vaccination (IVORY2)

June 27, 2025 updated by: Institut Pasteur

Vaccine protection depends on a specific adaptive immune memory. However, a little-explored aspect of certain live vaccines may provide beneficial, non-specific protection against infections or pathogens other than the one from which the vaccine is derived. This is the concept of innate immune memory or " trained immunity", which differs from adaptive memory in its non-specificity. Innate immune memory is triggered by exposure to immunostimulants, and offers protection against unrelated pathogenic threats for several months or even years.

The project aims to carry out an exploratory study to observe, in the context of current practice, the immune response obtained after a subunit and a live attenuated vaccine

Study Overview

Status

Recruiting

Detailed Description

Vaccine protection depends on a specific adaptive immune memory. However, a little-explored aspect of certain live vaccines may provide beneficial, non-specific protection against infections or pathogens other than the one from which the vaccine is derived. This is the concept of innate immune memory or " trained immunity", which differs from adaptive memory in its non-specificity. Innate immune memory is triggered by exposure to immunostimulants, and offers protection against unrelated pathogenic threats for several months or even years.

For example, research has shown that the live attenuated BCG vaccine induce non-specific trained immunity, enabling innate immune cells to remember their first encounter and improve their immune status during a second confrontation with similar or different agents.

Other currently available live vaccines, such as BCG , could also "train" innate immune cells.

The project aims to carry out an exploratory study to observe, in the context of current practice, the immune response obtained after a subunit and a live attenuated vaccine

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Paris, France, 75015
        • Recruiting
        • Centre Médical de l'Institut Pasteur
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18 and 65
  • Referred for immunisation against yellow fever and typhoid
  • Any person with indication for the following vaccinations :
  • Yellow fever
  • Typhoïd
  • Whose vaccination schedule includes two appointments 7 days apart
  • Whose state of health is compatible with a single 51 ml blood sample collection
  • Have consented to participate in the Ivory2 study
  • Benefiting from a Social Security plan or equivalent

Exclusion Criteria:

  • Anyone with a contraindication to yellow fever and/or typhoid vaccination.
  • Any person who has been vaccinated against yellow fever and/or typhoid.
  • Anyone who has lived in an endemic area (≥ 1 year) and/or has a history of Typhoid.
  • Anyone who is unable to attend the visit 1-month after the typhoid vaccine injection.
  • Women claiming to be pregnant or breast-feeding
  • Anyone unable to give informed consent for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: People with an indication for primary immunization against yellow fever and typhoid
People with an indication for primary immunization against yellow fever and typhoid and whose vaccination schedule includes two appointments 7 days apart
blood samples collected at D0 ,W1, W5, M3 and M6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological profile of PBMCs, before and after yellow fever vaccination
Time Frame: 6 months
Cytokine production assays (e.g. TNFa, IL6, IL1b)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the response to TyphimVi® vaccine
Time Frame: 6 months
ELISA-based quantification of Anti-Vi antibody level >30 U/mL at week 5, and/or fold increase ≥2 compared with pre-vaccination IgG titer.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fabien Taieb, Dr, Institut Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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