Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults
Phase 3
Completed
- Conditions
- COVID-19
- Interventions
- Biological: Candidate vaccine, SCB-2019Biological: Vaxzevria VaccineBiological: CoronaVac VaccineBiological: Comirnaty Vaccine
- Registration Number
- NCT05188677
- Lead Sponsor
- Clover Biopharmaceuticals AUS Pty Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1831
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2a (primary series: Vaxzevria) Candidate vaccine, SCB-2019 participants will receive one dose of SCB-2019 vaccine on Day 1 Group 2b (primary series: Vaxzevria) Vaxzevria Vaccine participants will receive one dose of Vaxzevria vaccine on Day 1 Group 1a (primary series: Comirnaty) Candidate vaccine, SCB-2019 participants will receive one dose of SCB-2019 vaccine on Day 1 Group 3b (primary series: CoronaVac) CoronaVac Vaccine participants will receive one dose of CoronaVac vaccine on Day 1 Group 1b (primary series: Comirnaty) Comirnaty Vaccine participants will receive one dose of Comirnaty vaccine on Day 1 Group 4a (primary series and booster dose CoronaVac) Candidate vaccine, SCB-2019 participants will receive one dose of SCB-2019 vaccine on Day 1 Group 4b (primary series and booster dose CoronaVac) CoronaVac Vaccine participants will receive one dose of CoronaVac on Day 1; Group 5a (primary series: CoronaVac) Candidate vaccine, SCB-2019 participants will receive a dose of 2-vial presentation of SCB-2019 vaccine Group 4c (primary series and booster dose CoronaVac) Candidate vaccine, SCB-2019 participants will receive a half dose of SCB-2019 vaccine on Day 1 Group 3a (primary series: CoronaVac) Candidate vaccine, SCB-2019 participants will receive one dose of SCB-2019 vaccine on Day 1 Group 5b (primary series: CoronaVac) Candidate vaccine, SCB-2019 participants will receive a dose of 3-vial presentation of SCB-2019 vaccine
- Primary Outcome Measures
Name Time Method GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15 Day 15 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 Local and systemic solicited AEs reported within 7 days after study vaccination Up to 7 days after each vaccination SAEs, AEs leading to early termination from the study, MAAEs, and AESIs Through study completion, an average of 6 Months Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29 Up to Day 29
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Manila Doctors Hospital
🇵🇭Manila, Metro Manila, Philippines
Las Piñas Doctors Hospital
🇵🇭Las Piñas, Metro Manila, Philippines