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NCT Number: NCT03875703

Post-Vaccination Biological Collection

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pr Gallien

Créteil, 94000, France

Location status: Recruiting

Location contact

Sebastien Gallien, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in transcriptional analysis, analysis of the innate immune response after vaccination

    Time frame: Hour 24 after vaccination

    Transcriptomic analysis performed from whole blood samples

Secondary outcomes

  1. B cell immune response

    Time frame: 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

    Time frame: 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

    Time frame: at Month 1

Study contacts

Contact information is provided by the study sponsor or research team.

Sébastien Gallien, PHD

CONTACT

[email protected]

01 49 81 44 33 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Biological Collection for Studying Vaccine-induced Immune Responses

Acronym: BioCol-VIR

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Mar 15, 2019
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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