Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study

NCT06373510 | Not Yet Recruiting

• 1 other identifier: ELCAV
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population . Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies.

Conditions

Vaccination Reaction

Outcome Measures

Primary Outcomes (1)

• Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.

  Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.

  3 years

Study Arms (1)

Observational arm

OTHER

Biological: Blood collection

Interventions

Blood collection BIOLOGICAL

Collection of blood before and after a non mandatory vaccination

Observational arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject over 18 years of age
• Subject presenting to the investigation centre as part of its usual management (prevention, screening, tracking)
• Subject who has been vaccinated and/or wishes to be vaccinated
• Subject able to understand the purpose of research that has given free and informed express consent
• Member or beneficiary of a social security scheme

You may not qualify if:

• Protected subject: major under guardianship, curatorship or other legal protection, deprived of liberty by decision judicial or administrative

Sponsors & Collaborators

• CerbaXpert: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Barbara Perniconi

CONTACT

0671296728; bperniconi@cerbaresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 18, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): April 3, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share