Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults

Overview

The purpose of this study is to assess the immunogenicity and safety of the investigational SCB-2019 vaccine, administered as a booster dose, to adults who received primary series with one of the selected authorized or investigational COVID-19 vaccines or SCB-2019 vaccine at least 3 months prior to enrollment.

Full Title of Study: “A Multi-center, Observer-blind, Randomized, Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019), Administered as a Booster Dose to Adults, Who Previously Received Primary Series of a COVID-19 Vaccine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2022

Interventions

  • Biological: Candidate vaccine, SCB-2019
    • a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
  • Biological: Comirnaty Vaccine
    • intramuscular injection
  • Biological: COVID-19 Vaccine Janssen
    • intramuscular injection
  • Biological: CoronaVac Vaccine
    • intramuscular injection

Arms, Groups and Cohorts

  • Active Comparator: Group 1a (primary series: Comirnaty)
    • participants will receive one dose of Comirnaty vaccine on Day 1
  • Experimental: Group 1b (primary series: Comirnaty)
    • participants will receive one dose of SCB-2019 vaccine on Day 1
  • Active Comparator: Group 2a (primary series: COVID-19 Vaccine Janssen)
    • participants will receive one dose of COVID-19 Vaccine Janssen on Day 1
  • Experimental: Group 2b (primary series: COVID-19 Vaccine Janssen)
    • participants will receive one dose of SCB-2019 vaccine on Day 1
  • Active Comparator: Group 3a (primary series: CoronaVac)
    • participants will receive one dose of CoronaVac vaccine on Day 1
  • Experimental: Group 3b (primary series: CoronaVac)
    • participants will receive one dose of SCB-2019 vaccine on Day 1

Clinical Trial Outcome Measures

Primary Measures

  • GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15
    • Time Frame: Day 15
  • GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15
    • Time Frame: Day 15
  • GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15
    • Time Frame: Day 15
  • Local and systemic solicited AEs reported within 7 days after study vaccination
    • Time Frame: Up to 7 days after each vaccination
  • Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29
    • Time Frame: Up to Day 29
  • SAEs, AEs leading to early termination from the study, MAAEs, and AESIs
    • Time Frame: Through study completion, an average of 6 Months

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female participants at least 18 years of age; – Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures; – Individuals willing and able to give an informed consent, prior to screening; – Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition; – Individuals who received primary series with SCB-2019 vaccine or one of the selected authorized or investigational COVID-19 vaccines (Comirnaty, COVID-19 Vaccine Janssen, or CoronaVac) at least 3 months prior to enrollment. Exclusion Criteria:

  • Individuals with fever >37.5°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization; – Individuals with laboratory-confirmed SARS-CoV-2 infection at Visit 1 (determined by positive Rapid Antigen Test or RT-PCR); – Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for primary series with Comirnaty, COVID-19 Vaccine Janssen, or CoronaVac vaccines or with SCB-2019 vaccine as part of CLO-SCB-2019-003 study), or plan to receive COVID-19 vaccine during the study period; – Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines; – Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Clover Biopharmaceuticals AUS Pty Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Eric Plennevaux, PhD, +33674938689, eric.plennevaux@cloverbiopharma.com

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