Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults
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
1 other identifier
interventional
1,831
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Jun 2022
Typical duration for phase_3 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedStudy Start
First participant enrolled
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2023
CompletedAugust 24, 2023
August 1, 2023
12 months
January 10, 2022
August 23, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (11)
Group 1a (primary series: Comirnaty)
EXPERIMENTALparticipants will receive one dose of SCB-2019 vaccine on Day 1
Group 1b (primary series: Comirnaty)
ACTIVE COMPARATORparticipants will receive one dose of Comirnaty vaccine on Day 1
Group 2a (primary series: Vaxzevria)
EXPERIMENTALparticipants will receive one dose of SCB-2019 vaccine on Day 1
Group 2b (primary series: Vaxzevria)
ACTIVE COMPARATORparticipants will receive one dose of Vaxzevria vaccine on Day 1
Group 3a (primary series: CoronaVac)
EXPERIMENTALparticipants will receive one dose of SCB-2019 vaccine on Day 1
Group 3b (primary series: CoronaVac)
ACTIVE COMPARATORparticipants will receive one dose of CoronaVac vaccine on Day 1
Group 4a (primary series and booster dose CoronaVac)
EXPERIMENTALparticipants will receive one dose of SCB-2019 vaccine on Day 1
Group 4b (primary series and booster dose CoronaVac)
ACTIVE COMPARATORparticipants will receive one dose of CoronaVac on Day 1;
Group 4c (primary series and booster dose CoronaVac)
EXPERIMENTALparticipants will receive a half dose of SCB-2019 vaccine on Day 1
Group 5a (primary series: CoronaVac)
EXPERIMENTALparticipants will receive a dose of 2-vial presentation of SCB-2019 vaccine
Group 5b (primary series: CoronaVac)
EXPERIMENTALparticipants will receive a dose of 3-vial presentation of SCB-2019 vaccine
Interventions
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Las Piñas Doctors Hospital
Las Piñas, National Capital Region, 1741, Philippines
Manila Doctors Hospital
Manila, National Capital Region, 1000, Philippines
Related Publications (1)
Roa CC Jr, de Los Reyes MRA, Plennevaux E, Smolenov I, Hu B, Gao F, Ilagan H, Ambrosino D, Siber G, Clemens R. Superior Boosting of Neutralizing Titers Against Omicron SARS-CoV-2 Variants by Heterologous SCB-2019 Vaccine vs a Homologous Booster in CoronaVac-Primed Adults. J Infect Dis. 2023 Nov 2;228(9):1253-1262. doi: 10.1093/infdis/jiad262.
PMID: 37439701DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
January 12, 2022
Study Start
June 13, 2022
Primary Completion
June 6, 2023
Study Completion
June 6, 2023
Last Updated
August 24, 2023
Record last verified: 2023-08