Vaccination of older persons against SARS-CoV2 and inducing cellular immunity

Phase 1

• Conditions: SARS-CoV-19, frailty; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-002363-22-NL
• Lead Sponsor: ational Institute for Public Health and the Environment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-27
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

•Having participated the ISA study (part of the DCS).
•Willing to receive the SARS-CoV-2 vaccine.
•Willing to give the Informed Consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

A potential subject will be excluded from participation in this study when a person already received the second primary SARS-CoV-2 vaccination more than a month earlier and has not signed the ICF at T0, T1 or T2 .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified