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

Vaccination Reaction Clinical Trial

— ELCAV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373510
• Other study ID #: ELCAV
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: April 3, 2027

Study information

• Verified date: April 2024
• Source: CerbaXpert
• Contact: Barbara Perniconi
• Phone: 0671296728
• Email: bperniconi[@]cerbaresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: April 3, 2027
• Est. primary completion date: April 3, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Vaccination Reaction

Intervention

Biological:
• Blood collection
Collection of blood before and after a non mandatory vaccination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CerbaXpert

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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