Post-Vaccination Biological Collection

Vaccination Clinical Trial

— BioCol-VIR  

Official title:

Biological Collection for Studying Vaccine-induced Immune Responses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03875703
• Other study ID #: K170603J
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Immune Response
• Vaccination

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