| NCT ID | NCT03875703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Vaccination |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2030-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2019-09-01 with a primary completion date of 2030-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Laetitia Gregoire
STUDY CHAIR
APHP URC
Frequently Asked Questions
Who can join the NCT03875703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vaccination. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03875703 currently recruiting?
Yes, NCT03875703 is actively recruiting participants. Contact the research team at sebastien.gallien@aphp.fr for enrollment information.
Where is the NCT03875703 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT03875703 clinical trial?
NCT03875703 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Laetitia Gregoire at APHP URC. The trial plans to enroll 1,200 participants.