- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06718127
Description of the Immune Response to Yellow Fever Vaccination (IVORY2)
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica Quintin, Dr
- Phone Number: +33 144389454
- Email: jessica.quintin@pasteur.fr
Study Contact Backup
- Name: Sandrine Fernandes Pellerin
- Phone Number: +33 145688179
- Email: sandrine.fernandes-pellerin@pasteur.fr
Study Locations
-
-
-
Paris, France, 75015
- Recruiting
- Centre Médical de l'Institut Pasteur
-
Contact:
- Fabien TAIEB, Dr
- Phone Number: +33 1 45 68 80 88
- Email: fabien.taieb@pasteur.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Fabien Taieb, Dr, Institut Pasteur
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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