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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188677
• Other study ID #: CLO-SCB-2019-015
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2022
• Est. completion date: June 6, 2023

Study information

• Verified date: August 2023
• Source: Clover Biopharmaceuticals AUS Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1831
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Philippines	Las Piñas Doctors Hospital	Las Piñas	Metro Manila
Philippines	Manila Doctors Hospital	Manila	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
Clover Biopharmaceuticals AUS Pty Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

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