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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03875703
Other study ID # K170603J
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date February 1, 2030

Study information

Verified date December 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Sébastien Gallien, PHD
Phone 01 49 81 44 33
Email sebastien.gallien@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date February 1, 2030
Est. primary completion date February 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Pr Gallien Créteil

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in transcriptional analysis, analysis of the innate immune response after vaccination Transcriptomic analysis performed from whole blood samples Hour 24 after vaccination
Secondary 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
Secondary 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
Secondary Specific antibody response to the used vaccines at M1 at Month 1
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