Post-Vaccination Biological Collection (BioCol-VIR)

Biological Collection for Studying Vaccine-induced Immune Responses

Introduction: Vaccination is a powerful weapon in the fight against infectious diseases, which has led to dramatic reduction in mortality and complications from some diseases. In this respect, vaccination is a real worldwide public health challenge (WHO). Thus, vaccine research benefits from an exponential development of knowledge in immunology and biotechnology. In particular, the advent of recent tools ("omics", new cytometric assays) and the description of new categories of immune cells (Tfh, BReg...) have revolutionized the characterization of immune responses, particularly post-vaccination. To study of the immune response following vaccination remains essential in order to define the immunological correlates to vaccine protection. This response also varies according to parameters related to the vaccine (type, adjuvant, dose, regimen…) and to the vaccinated host (genetics, age, morbidity, treatment …). Analyzing with new generation immune assays, new data on immunological responses post-vaccination from a clinical cohort is therefore essential to better define these correlates.

Objective: To develop new vaccines (HIV, emerging infectious diseases) the investigators use a "System vaccinology" method to decipher the mechanisms of immune responses set up against vaccines currently being developed or marketed, specifically in specific populations (patients with primary immune deficiency, sickle cell patients, solid organ transplanted patients, COPD).

Method: Description of the genetic, molecular and cellular mechanisms of the immune response to vaccines recommended for adults, in particular influenza and pneumococcal vaccines, but also other mandatory vaccines (MMR,...) or vaccine for travelers (yellow fever, ...) as part of routine care in different population categories (healthy subjects, HIV+ subjects, COPD patients, …), using qualitative and quantitative immunological assays: transcriptional analysis of the dynamic innate immune response, analysis of the lymphocytes B & T responses (phenotype, repertoire analysis, functional analysis including T reg and TFH populations, antibody response), genetic analysis in the context of primary immune deficiencies) Conclusion: The data generated will allow the best possible analysis of vaccine responses according to vaccines and vaccinated populations, providing important information for the research developed within the department.

Study Overview

• Status: Recruiting
• Conditions: Immune Response; Vaccination

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Sébastien Gallien, PHD; Phone Number: +33 01 49 81 44 33; Email: sebastien.gallien@aphp.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • Pr Gallien
    • Contact: Sebastien Gallien, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who receive a vaccination in the department of Immunology and Infectious Diseases of the Henri Mondor University Hospital (Créteil, France).

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Informed and consented
• Need to be vaccinated for routine care

Exclusion Criteria:

• Person under guardianship or safeguards
• Pregnant or breastfeeding woman
• No affiliation to a health insurance scheme

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in transcriptional analysis, analysis of the innate immune response after vaccination	Transcriptomic analysis performed from whole blood samples	Hour 24 after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B cell immune response	(phenotype, analysis of the repertoire B, functional analysis, antibody response, plasmablastic response)	at Day 0, Day 7, Day 14 and Month 1 after vaccination
T cell immune response	(phenotype, T repertoire analysis, functional analysis, especially of the Treg and TFH populations)	at Day 0, Day 7, Day 14 and Month 1 after vaccination
Specific antibody response to the used vaccines at M1		at Month 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Study Chair: Laetitia Gregoire, APHP URC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): February 1, 2030
• Study Completion (Anticipated): February 1, 2030

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Vaccination; Biological Collection; Active Immune Response
• Other Study ID Numbers: K170603J

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No