Post-Vaccination Biological Collection

NCT03875703 | Recruiting DMC

• 1 other identifier: K170603J
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination; Immune Response

Keywords

Biological Collection; Vaccination; Active Immune Response

Outcome Measures

Primary Outcomes (1)

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

  Transcriptomic analysis performed from whole blood samples

  Hour 24 after vaccination

Secondary Outcomes (3)

• B cell immune response

  at Day 0, Day 7, Day 14 and Month 1 after vaccination

• T cell immune response

  at Day 0, Day 7, Day 14 and Month 1 after vaccination

• Specific antibody response to the used vaccines at M1

  at Month 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Pr Gallien

Créteil, 94000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood \& serum

Study Officials

• Laetitia Gregoire

  APHP URC

  STUDY CHAIR

Central Study Contacts

Sébastien Gallien, PHD

CONTACT

01 49 81 44 33; sebastien.gallien@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: March 15, 2019
• Study Start: September 1, 2019
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

FR (1)