BioCol-VIR: Post-Vaccination Biological Collection

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT03875703
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
1,200
1
125
9.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Biological Collection for Studying Vaccine-induced Immune Responses
    Actual Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Feb 1, 2030
    Anticipated Study Completion Date :
    Feb 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Change in transcriptional analysis, analysis of the innate immune response after vaccination [Hour 24 after vaccination]

      Transcriptomic analysis performed from whole blood samples

    Secondary Outcome Measures

    1. B cell immune response [at Day 0, Day 7, Day 14 and Month 1 after vaccination]

      (phenotype, analysis of the repertoire B, functional analysis, antibody response, plasmablastic response)

    2. T cell immune response [at Day 0, Day 7, Day 14 and Month 1 after vaccination]

      (phenotype, T repertoire analysis, functional analysis, especially of the Treg and TFH populations)

    3. Specific antibody response to the used vaccines at M1 [at Month 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pr Gallien Créteil France 94000

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris
    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    • Study Chair: Laetitia Gregoire, APHP URC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT03875703
    Other Study ID Numbers:
    • K170603J
    First Posted:
    Mar 15, 2019
    Last Update Posted:
    Dec 14, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris

    Study Results

    No Results Posted as of Dec 14, 2020