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A Trial Among HealthCare Workers (HCW) Vaccinated With Janssen Vaccine: the SWITCH Trial (SWITCH)

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ClinicalTrials.gov Identifier: NCT04927936
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : June 30, 2021
Sponsor:
Collaborators:
Leiden University Medical Center
University Medical Center Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Hugo van der Kuy, Erasmus Medical Center

Brief Summary:

The key objective of the study is to measure the immune response against SARS-CoV-2 after different vaccinations in Health Care Workers (HCW) from 18 to 65 years old vaccinated once with Janssen vaccine.

Determination of antibodies by a quantitative immunoglobulin G (IgG) assay (LIAISON SARS-CoV-2 TRIMERICS IgG essay) 28 days after second vaccination (booster) comparing, per protocol, the following three groups:

  1. Janssen vaccine/- vs. Janssen vaccine/Janssen vaccine
  2. Janssen vaccine/Janssen vaccine vs. Janssen vaccine/Pfizer vaccine
  3. Janssen vaccine/Janssen vaccine vs. Janssen vaccine/Moderna vaccine

Condition or disease Intervention/treatment Phase
Covid19 Biological: Vaccination once with Janssen vaccine (only priming) Biological: Vaccination with Janssen vaccine followed with Janssen vaccine (homologous boosting). Biological: Vaccination with Janssen vaccine followed with Moderna vaccine (heterologous boosting). Biological: Vaccination with Janssen vaccine followed with Pfizer vaccine (heterologous boosting). Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A multicenter, randomised, single-blind, controlled trial to determine reactogenicity and immunogenicity of different prime-boost COVID-19 vaccine schedules.

Setting Multicenter study conducted through 4 academic trial sites (Amsterdam UMC, Erasmus MC, Leiden UMC, and UMC Groningen).

Trial duration Total duration of each participant will be 12 months from the administration of the boost vaccine dose.

Masking: Single (Participant)
Masking Description:

Participants will be randomised per cohort in 1:1:1:1 fashion using block randomisation.

The study will be single-blind. Staff involved in study will be aware of which vaccine the participant is receiving (arm allocation); the participants will remain blinded to their vaccine allocation.

Seven days (after filling in the questionnaires regarding side-effects) after the boost (2nd vaccination) the vaccination strategy will be unblinded. Directly after the boost (2nd vaccination) a letter will be given in which the study is explained and a statement is given that a second vaccination is given.

Those participants receiving only one shot with Janssen will only be told on the day of planned boost (2nd vaccination). They will not be vaccinated with placebo.

Primary Purpose: Prevention
Official Title: A Multicenter, Randomised, Single-blind, Controlled Trial Among HealthCare Workers (HCW) Vaccinated With Janssen Vaccine: the SWITCH Trial
Actual Study Start Date : June 25, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Active Comparator: Janssen vaccine only

HCW already vaccinated with Janssen vaccine once. 84 days after the first vaccination, blood samples will be drawn (day =0, baseline) This will be repeated at day 28 (primary endpoint), day 180 and day 365. This arm will have 87 +25% seropositive for SARS-CoV-2 IgG at baseline or loss to follow-up = 108 participants.

In this arm half of the participants will undergo a detailed immunological assessment (n=54 per arm).

Biological: Vaccination once with Janssen vaccine (only priming)
Vaccination (priming) with janssen vaccine. There is no boosting.

Experimental: Janssen vaccine - Janssen vaccine

HCW already vaccinated with Janssen vaccine once. 84 days after the first vaccination a boost will be given with Janssen vaccine and blood samples will be drawn (day =0, baseline) This will be repeated at day 28 (primary endpoint), day 180 and day 365. This arm will have 87 +25% seropositive for SARS-CoV-2 IgG at baseline or loss to follow-up = 108 participants.

In this arm half of the participants will undergo a detailed immunological assessment (n=54 per arm).

Biological: Vaccination with Janssen vaccine followed with Janssen vaccine (homologous boosting).
Vaccination (priming) with janssen vaccine. There is boosting with Janssen vaccine.

Experimental: Janssen vaccine - Moderna vaccine

HCW already vaccinated with Janssen vaccine once. 84 days after the first vaccination a boost will be given with Moderna vaccine and blood samples will be drawn (day =0, baseline) This will be repeated at day 28 (primary endpoint), day 180 and day 365. This arm will have 87 +25% seropositive for SARS-CoV-2 IgG at baseline or loss to follow-up = 108 participants.

In this arm half of the participants will undergo a detailed immunological assessment (n=54 per arm).

Biological: Vaccination with Janssen vaccine followed with Moderna vaccine (heterologous boosting).
Vaccination (priming) with janssen vaccine. There is boosting with Moderna vaccine.

Experimental: Janssen vaccine - Pfizer vaccine

HCW already vaccinated with Janssen vaccine once. 84 days after the first vaccination a boost will be given with Pfizer vaccine and blood samples will be drawn (day =0, baseline) This will be repeated at day 28 (primary endpoint), day 180 and day 365. This arm will have 87 +25% seropositive for SARS-CoV-2 IgG at baseline or loss to follow-up = 108 participants.

In this arm half of the participants will undergo a detailed immunological assessment (n=54 per arm).

Biological: Vaccination with Janssen vaccine followed with Pfizer vaccine (heterologous boosting).
Vaccination (priming) with janssen vaccine. There is boosting with Pfizer vaccine.




Primary Outcome Measures :
  1. Determination of antibodies by a quantitative IgG assay (LIAISON SARS-CoV-2 TrimericS IgG essay) 28 days after booster [ Time Frame: 28 days after booster ]
    LIAISON® SARS-CoV-2 TrimericS IgG assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participant is willing and able to give written informed consent for participation in the trial.
  2. Adult (male/female) between 18 and 65 years old
  3. Sufficient level of the Dutch language to undertake all study requirements

Exclusion Criteria:

  1. Adults younger than 18 or older than 65 years
  2. Adults already vaccinated with other vaccine then Janssen
  3. Previously had a COVID-19 infection
  4. History of allergic reaction likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the ingredients of the Janssen/Pfizer/Moderna vaccine).
  5. Adults that are pregnant or have a wish to become pregnant within 6 months
  6. Currently being treated for cancer
  7. Severe kidney failure or dialyses dependent
  8. Status after organ-, stem cell- or bone marrow transplantation
  9. Use of immunosuppressant's
  10. Epilepsy
  11. HIV
  12. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following injections of vene puncture
  13. Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc).
  14. Participants who are currently participating in another research trial.
  15. All regular contra-indications of the vaccines will be applied.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927936


Contacts
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Contact: Hugo van der Kuy, PhD, PharmD +31628586702 h.vanderkuy@erasmusmc.nl
Contact: Roos Sablerolles, MD r.sablerolles@erasmusmc.nl

Locations
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Netherlands
AmsterdamUMC Not yet recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Bram Goorhuis, MD, PhD       a.goorhuis@amsterdamumc.nl   
UMCG Not yet recruiting
Groningen, Netherlands, 9713GZ
Contact: Douwe Postma, MD, PhD       d..f.postma@umcg.nl   
LUMC Not yet recruiting
Leiden, Netherlands, 2333ZA
Contact: Leo Visser, MD, PhD       l.g.visser@lumc.nl   
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Hugo van der Kuy, PhD, PharmD    +31628586702    h.vanderkuy@erasmusmc.nl   
Contact: Roos Sablerolles, MD       r.sablerolles@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
Leiden University Medical Center
University Medical Center Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Hugo van der Kuy, PhD, PharmD Erasmus MC
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Responsible Party: Hugo van der Kuy, Prof dr, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04927936    
Other Study ID Numbers: MEC-2021-0132
2021-000701-24 ( EudraCT Number )
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On reasonable request to the study coordinator data will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will become available within 12 months after the end of the study.
Access Criteria: Reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hugo van der Kuy, Erasmus Medical Center:
vaccination
heterologous boosting
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs