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

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

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 at least 3 months prior to enrollment.
• Received primary series and a booster dose of CoronaVac at least 3 months prior to enrollment.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Candidate vaccine, SCB-2019; Biological: Comirnaty Vaccine; Biological: Vaxzevria Vaccine; Biological: CoronaVac Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1831
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Eric Plennevaux, PhD; Phone Number: +33674938689; Email: eric.plennevaux@cloverbiopharma.com

Study Locations

• Philippines
  • Metro Manila
    • Las Piñas, Metro Manila, Philippines, 1741
      • Las Pinas Doctors Hospital
    • Manila, Metro Manila, Philippines, 1000
      • Manila Doctors Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 vaccination series with one of the selected COVID-19 vaccines (Comirnaty, Vaxzevria, or CoronaVac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of CoronaVac, ≥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, Vaxzevria, CoronaVac vaccines, or primary and booster dose of CoronaVac), 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1a (primary series: Comirnaty); participants will receive one dose of SCB-2019 vaccine on Day 1	Biological: Candidate vaccine, SCB-2019; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 1b (primary series: Comirnaty); participants will receive one dose of Comirnaty vaccine on Day 1	Biological: Comirnaty Vaccine; intramuscular injection
Experimental: Group 2a (primary series: Vaxzevria); participants will receive one dose of SCB-2019 vaccine on Day 1	Biological: Candidate vaccine, SCB-2019; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 2b (primary series: Vaxzevria); participants will receive one dose of Vaxzevria vaccine on Day 1	Biological: Vaxzevria Vaccine; intramuscular injection
Experimental: Group 3a (primary series: CoronaVac); participants will receive one dose of SCB-2019 vaccine on Day 1	Biological: Candidate vaccine, SCB-2019; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 3b (primary series: CoronaVac); participants will receive one dose of CoronaVac vaccine on Day 1	Biological: CoronaVac Vaccine; intramuscular injection
Experimental: Group 4a (primary series and booster dose CoronaVac); participants will receive one dose of SCB-2019 vaccine on Day 1	Biological: Candidate vaccine, SCB-2019; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 4b (primary series and booster dose CoronaVac); participants will receive one dose of CoronaVac on Day 1;	Biological: CoronaVac Vaccine; intramuscular injection
Experimental: Group 4c (primary series and booster dose CoronaVac); participants will receive a half dose of SCB-2019 vaccine on Day 1	Biological: Candidate vaccine, SCB-2019; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Experimental: Group 5a (primary series: CoronaVac); participants will receive a dose of 2-vial presentation of SCB-2019 vaccine	Biological: Candidate vaccine, SCB-2019; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Experimental: Group 5b (primary series: CoronaVac); participants will receive a dose of 3-vial presentation of SCB-2019 vaccine	Biological: Candidate vaccine, SCB-2019; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clover Biopharmaceuticals AUS Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CLO-SCB-2019-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No