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

Clover Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Biological: Vaxzevria Vaccine; Biological: Comirnaty Vaccine; Biological: Candidate vaccine, SCB-2019; Biological: CoronaVac Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05188677

CLO-SCB-2019-015

Details and patient eligibility

About

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.

Enrollment: 1,831 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,831 participants in 11 patient groups

Group 1a (primary series: Comirnaty)

Experimental group

Description:

participants will receive one dose of SCB-2019 vaccine on Day 1

Treatment:

Biological: Candidate vaccine, SCB-2019

Group 1b (primary series: Comirnaty)

Active Comparator group

Description:

participants will receive one dose of Comirnaty vaccine on Day 1

Treatment:

Biological: Comirnaty Vaccine

Group 2a (primary series: Vaxzevria)

Experimental group

Description:

participants will receive one dose of SCB-2019 vaccine on Day 1

Treatment:

Biological: Candidate vaccine, SCB-2019

Group 2b (primary series: Vaxzevria)

Active Comparator group

Description:

participants will receive one dose of Vaxzevria vaccine on Day 1

Treatment:

Biological: Vaxzevria Vaccine

Group 3a (primary series: CoronaVac)

Experimental group

Description:

participants will receive one dose of SCB-2019 vaccine on Day 1

Treatment:

Biological: Candidate vaccine, SCB-2019

Group 3b (primary series: CoronaVac)

Active Comparator group

Description:

participants will receive one dose of CoronaVac vaccine on Day 1

Treatment:

Biological: CoronaVac Vaccine

Group 4a (primary series and booster dose CoronaVac)

Experimental group

Description:

participants will receive one dose of SCB-2019 vaccine on Day 1

Treatment:

Biological: Candidate vaccine, SCB-2019

Group 4b (primary series and booster dose CoronaVac)

Active Comparator group

Description:

participants will receive one dose of CoronaVac on Day 1;

Treatment:

Biological: CoronaVac Vaccine

Group 4c (primary series and booster dose CoronaVac)

Experimental group

Description:

participants will receive a half dose of SCB-2019 vaccine on Day 1

Treatment:

Biological: Candidate vaccine, SCB-2019

Group 5a (primary series: CoronaVac)

Experimental group

Description:

participants will receive a dose of 2-vial presentation of SCB-2019 vaccine

Treatment:

Biological: Candidate vaccine, SCB-2019

Group 5b (primary series: CoronaVac)

Experimental group

Description:

participants will receive a dose of 3-vial presentation of SCB-2019 vaccine

Treatment:

Biological: Candidate vaccine, SCB-2019