Clinical trial NCT03875703: Post-Vaccination Biological Collection
Official title: Biological Collection for Studying Vaccine-induced Immune Responses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaccination
Immune Response
Keywords: Biological Collection
Vaccination
Active Immune Response
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-03-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in transcriptional analysis, analysis of the innate immune response after vaccination
timeFrame: Hour 24 after vaccination
Secondary outcomes:
measure: B cell immune response
timeFrame: at Day 0, Day 7, Day 14 and Month 1 after vaccination
measure: T cell immune response
timeFrame: at Day 0, Day 7, Day 14 and Month 1 after vaccination
measure: Specific antibody response to the used vaccines at M1
timeFrame: at Month 1
Other outcomes:
Locations:
city: Créteil
country: France
facility: Pr Gallien
Study officials:
affiliation: APHP URC
name: Laetitia Gregoire
role: STUDY_CHAIR
References: