Switching of COVID-19 Vaccines: a solution for the problems?

Phase 1

• Conditions: Health Care Workers of the Erasmus Medical Centre will be vaccinated with Covid-19 vaccinations. They will either receive two the same vaccines or two different after which immune response will be measured; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-000701-24-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-22
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

All HCW who work in the health care facility with at least one confirmed SARS CoV-2 infected patient receiving care and who have symptoms associated with SARS CoV-2.
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 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.HCW younger than 18
2.HCW that are pregnant or have a wish to become pregnant within 6 months
3.All regular contra-indications of the vaccines will be applied

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to measure the immune response against SARS-CoV-2 after two different vaccinations in Health Care Workers (HCW) (intervention group). This will be compared with HCW that will receive two boosts from the same vaccines (control group).;Secondary Objective: 1. To assess adverse events after SARS-CoV-2 vaccination. <br>2. To evaluate development of antibody and cellular response after 1st vaccination<br>3. To assess durability of the antibody response<br>4. To analyze the SARS-CoV-2-specific T and B cell response after vaccination<br>;Primary end point(s): Detection of immunity against SARS-CoV-2;Timepoint(s) of evaluation of this end point: At baseline and after SARS-CoV-2 vaccination, which will be performed according to standard of care, blood will be drawn at in 5 different time points, i.e. baseline (before 1st vaccination), at day of 2nd vaccination, and 28 days, and 6 and 12 months after 2nd vaccination.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA