Switching of COVID-19 vaccines: A solution for the problems? A multicentre, randomised, single blind, controlled trial among HealthCare Workers (HCW) vaccinated with Janssen: the SWITCH trial.

Switching of COVID-19 vaccines: A solution for the problems? A multicentre, randomised, single blind, controlled trial among HealthCare Workers (HCW) vaccinated with Janssen: the SWITCH trial. - SWITCH

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52043

Enrollment

461

Registered

2021-03-22

Start date

2021-06-26

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 vaccinations

Interventions

All adults in the Netherlands are vaccinated on a voluntary basis, the intervention is aimed at comparing homologous versus heterologous vaccination strategy. Key endpoints: The immune response to S

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All HCW who work in the health care facility without contra-indications, vaccinated already once with Janssen. December 2021 Only participants from the SWITCH in the Janssen solo group will be included.

Exclusion criteria

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 4. HCW with a confirmed SARS-COVID-19 infection

Design outcomes

Primary

Measure	Time frame
Primary objectives Measuring the SARS-CoV-2-specific immune response against SARS-CoV-2 after inoculation with a single-dose Janssen compared to a homologous vaccination regimen with Janssen /Janssen and the comparison of a homologous vaccination regimen (Janssen/Janssen) with a heterologous vaccination regimen (Janssen/Pfizer + Janssen/Moderna). Main endpoint The immune response to SARS CoV-2 28 days after the second vaccination is the primary endpoint. December 2021 Measuring the SARS-CoV-2 specific immune response to SARS-CoV-2 after inoculation with Pfizer 30 micrograms 6 months after priming versus 3 months. Main endpoint The immune response to SARS CoV-2 28 days after the second vaccination is the primary endpoint. February 2022 Extra boost Measuring the SARS-CoV-2 specific immune response against SARS-CoV-2 after inoculation with Pfizer 30 micrograms (as second boost) and comparing this immune response between the different groups (J/J, J/P and J/M). Waning Pharmacokinetic comparison of the decline of the immune response between the different groups (J/J, J/P and J/M). Non-responders Finding an indicator to predict/identify non-responders.	—

Measure

Time frame

Primary objectives Measuring the SARS-CoV-2-specific immune response against SARS-CoV-2 after inoculation with a single-dose Janssen compared to a homologous vaccination regimen with Janssen /Janssen and the comparison of a homologous vaccination regimen (Janssen/Janssen) with a heterologous vaccination regimen (Janssen/Pfizer + Janssen/Moderna). Main endpoint The immune response to SARS CoV-2 28 days after the second vaccination is the primary endpoint. December 2021 Measuring the SARS-CoV-2 specific immune response to SARS-CoV-2 after inoculation with Pfizer 30 micrograms 6 months after priming versus 3 months. Main endpoint The immune response to SARS CoV-2 28 days after the second vaccination is the primary endpoint. February 2022 Extra boost Measuring the SARS-CoV-2 specific immune response against SARS-CoV-2 after inoculation with Pfizer 30 micrograms (as second boost) and comparing this immune response between the different groups (J/J, J/P and J/M). Waning Pharmacokinetic comparison of the decline of the immune response between the different groups (J/J, J/P and J/M). Non-responders Finding an indicator to predict/identify non-responders.

—

Secondary

Measure	Time frame
Secondary objectives 1. To assess adverse events after SARS-CoV-2 vaccination. 2. To evaluate development of antibody and cellular response after homologues versus heterologues vaccination 3. To assess durability of the antibody response 4. To analyze the SARS-CoV-2-specific T and B cell response after vaccination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)