Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults
NCT ID: NCT05188677
Last Updated: 2023-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1831 participants
INTERVENTIONAL
2022-06-13
2023-06-06
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1a (primary series: Comirnaty)
participants will receive one dose of SCB-2019 vaccine on Day 1
Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Group 1b (primary series: Comirnaty)
participants will receive one dose of Comirnaty vaccine on Day 1
Comirnaty Vaccine
intramuscular injection
Group 2a (primary series: Vaxzevria)
participants will receive one dose of SCB-2019 vaccine on Day 1
Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Group 2b (primary series: Vaxzevria)
participants will receive one dose of Vaxzevria vaccine on Day 1
Vaxzevria Vaccine
intramuscular injection
Group 3a (primary series: CoronaVac)
participants will receive one dose of SCB-2019 vaccine on Day 1
Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Group 3b (primary series: CoronaVac)
participants will receive one dose of CoronaVac vaccine on Day 1
CoronaVac Vaccine
intramuscular injection
Group 4a (primary series and booster dose CoronaVac)
participants will receive one dose of SCB-2019 vaccine on Day 1
Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Group 4b (primary series and booster dose CoronaVac)
participants will receive one dose of CoronaVac on Day 1;
CoronaVac Vaccine
intramuscular injection
Group 4c (primary series and booster dose CoronaVac)
participants will receive a half dose of SCB-2019 vaccine on Day 1
Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Group 5a (primary series: CoronaVac)
participants will receive a dose of 2-vial presentation of SCB-2019 vaccine
Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Group 5b (primary series: CoronaVac)
participants will receive a dose of 3-vial presentation of SCB-2019 vaccine
Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Clover Biopharmaceuticals AUS Pty
INDUSTRY
Responsible Party
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Locations
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Las Piñas Doctors Hospital
Las Piñas, National Capital Region, Philippines
Manila Doctors Hospital
Manila, National Capital Region, Philippines
Countries
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References
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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.
Other Identifiers
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CLO-SCB-2019-015
Identifier Type: -
Identifier Source: org_study_id
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