COVID-19
Conditions
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.
Interventions
BIOLOGICALCandidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
BIOLOGICALComirnaty Vaccine
intramuscular injection
BIOLOGICALVaxzevria Vaccine
intramuscular injection
BIOLOGICALCoronaVac Vaccine
intramuscular injection
Sponsors
Clover Biopharmaceuticals AUS Pty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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 |
Countries
Philippines
Outcome results
None listed