Clinical trial NCT05188677: Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Clover Biopharmaceuticals, Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 1831
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15
timeFrame: Day 15
measure: GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15
timeFrame: Day 15
measure: GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15
timeFrame: Day 15
measure: Local and systemic solicited AEs reported within 7 days after study vaccination
timeFrame: Up to 7 days after each vaccination
measure: Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29
timeFrame: Up to Day 29
measure: SAEs, AEs leading to early termination from the study, MAAEs, and AESIs
timeFrame: Through study completion, an average of 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Piñas
country: Philippines
facility: Las Piñas Doctors Hospital
state: Metro Manila
city: Manila
country: Philippines
facility: Manila Doctors Hospital
state: Metro Manila
Study officials:
References: