Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies after COVID-19 Booster Vaccines – The CoVVacBoost Study - The CoVVacBoost Study

Phase 1

• Conditions: Covid (Coronavirus disease)- 19 immunisation; MedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-006172-16-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-16
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet the following inclusion criteria:

1. Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine and decided to receive a booster vaccination as recommended by national guidelines.
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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1.Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination.
2.Any contraindications to the vaccine planned to receive as listed in the product characteristics.
3.Lack of willingness to undergo serial blood draws and attend follow-up appointments.
4.Having already received a third (booster) vaccination with any COVID-19 vaccine.
5.Women who are pregnant or breastfeeding.
6.Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent)

Study & Design

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