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

NCT04927936 | Unknown

• 2 other identifiers: MEC-2021-01322021-000701-24
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 4

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

Conditions

Covid19

Keywords

vaccination; heterologous boosting

Outcome Measures

Primary Outcomes (1)

• Determination of antibodies by a quantitative IgG assay (LIAISON SARS-CoV-2 TrimericS IgG essay) 28 days after booster

  LIAISON® SARS-CoV-2 TrimericS IgG assay

  28 days after booster

Study Arms (4)

Janssen vaccine only

ACTIVE COMPARATOR

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)

Janssen vaccine - Janssen vaccine

EXPERIMENTAL

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).

Janssen vaccine - Moderna vaccine

EXPERIMENTAL

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).

Janssen vaccine - Pfizer vaccine

EXPERIMENTAL

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).

Interventions

Vaccination once with Janssen vaccine (only priming) BIOLOGICAL

Vaccination (priming) with janssen vaccine. There is no boosting.

Janssen vaccine only

Vaccination with Janssen vaccine followed with Janssen vaccine (homologous boosting). BIOLOGICAL

Vaccination (priming) with janssen vaccine. There is boosting with Janssen vaccine.

Janssen vaccine - Janssen vaccine

Vaccination with Janssen vaccine followed with Moderna vaccine (heterologous boosting). BIOLOGICAL

Vaccination (priming) with janssen vaccine. There is boosting with Moderna vaccine.

Janssen vaccine - Moderna vaccine

Vaccination with Janssen vaccine followed with Pfizer vaccine (heterologous boosting). BIOLOGICAL

Vaccination (priming) with janssen vaccine. There is boosting with Pfizer vaccine.

Janssen vaccine - Pfizer vaccine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Adults younger than 18 or older than 65 years
• Adults already vaccinated with other vaccine then Janssen
• Previously had a COVID-19 infection
• 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).
• Adults that are pregnant or have a wish to become pregnant within 6 months
• Currently being treated for cancer
• Severe kidney failure or dialyses dependent
• Status after organ-, stem cell- or bone marrow transplantation
• Use of immunosuppressant's
• Epilepsy
• HIV
• Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following injections of vene puncture
• Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc).
• Participants who are currently participating in another research trial.
• All regular contra-indications of the vaccines will be applied.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Leiden University Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (4)

AmsterdamUMC

Amsterdam, 1105AZ, Netherlands

NOT YET RECRUITING

UMCG

Groningen, 9713GZ, Netherlands

NOT YET RECRUITING

LUMC

Leiden, 2333ZA, Netherlands

NOT YET RECRUITING

Erasmus MC

Rotterdam, 3015 GD, Netherlands

RECRUITING

Related Publications (1)

• Sablerolles RSG, Rietdijk WJR, Goorhuis A, Postma DF, Visser LG, Geers D, Schmitz KS, Garcia Garrido HM, Koopmans MPG, Dalm VASH, Kootstra NA, Huckriede ALW, Lafeber M, van Baarle D, GeurtsvanKessel CH, de Vries RD, van der Kuy PHM; SWITCH Research Group. Immunogenicity and Reactogenicity of Vaccine Boosters after Ad26.COV2.S Priming. N Engl J Med. 2022 Mar 10;386(10):951-963. doi: 10.1056/NEJMoa2116747. Epub 2022 Jan 19.

  PMID: 35045226 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Hugo van der Kuy, PhD, PharmD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo van der Kuy, PhD, PharmD

CONTACT

+31628586702; h.vanderkuy@erasmusmc.nl

Roos Sablerolles, MD

CONTACT

r.sablerolles@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof dr

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 16, 2021
• Study Start: June 25, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available within 12 months after the end of the study.
• Access Criteria: Reasonable request

Locations

NL (4)