COVID-19Phase 3NCT05188677
Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults
A Phase 3 study testing Candidate vaccine, SCB-2019, Comirnaty Vaccine and Vaxzevria Vaccine in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 2 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Candidate vaccine, SCB-2019, Comirnaty Vaccine and Vaxzevria Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,831 participants
- Where
- 2 sitesPhilippines
- Study dates
- 13 Jun 2022to 6 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Las Piñas Doctors Hospital
Las Piñas, National Capital Region, 1741
Manila Doctors Hospital
Manila, National Capital Region, 1000
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Candidate vaccine, SCB-2019, Comirnaty Vaccine, Vaxzevria Vaccine, CoronaVac Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candidate vaccine, SCB-2019Biological
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Comirnaty VaccineBiological
intramuscular injection
Vaxzevria VaccineBiological
intramuscular injection
CoronaVac VaccineBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1a (primary series: Comirnaty) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 Receives: Biological: Candidate vaccine, SCB-2019 |
| Group 1b (primary series: Comirnaty) | Active comparator | participants will receive one dose of Comirnaty vaccine on Day 1 Receives: Biological: Comirnaty Vaccine |
| Group 2a (primary series: Vaxzevria) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 Receives: Biological: Candidate vaccine, SCB-2019 |
| Group 2b (primary series: Vaxzevria) | Active comparator | participants will receive one dose of Vaxzevria vaccine on Day 1 Receives: Biological: Vaxzevria Vaccine |
| Group 3a (primary series: CoronaVac) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 Receives: Biological: Candidate vaccine, SCB-2019 |
| Group 3b (primary series: CoronaVac) | Active comparator | participants will receive one dose of CoronaVac vaccine on Day 1 Receives: Biological: CoronaVac Vaccine |
| Group 4a (primary series and booster dose CoronaVac) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 Receives: Biological: Candidate vaccine, SCB-2019 |
| Group 4b (primary series and booster dose CoronaVac) | Active comparator | participants will receive one dose of CoronaVac on Day 1; Receives: Biological: CoronaVac Vaccine |
| Group 4c (primary series and booster dose CoronaVac) | Experimental | participants will receive a half dose of SCB-2019 vaccine on Day 1 Receives: Biological: Candidate vaccine, SCB-2019 |
| Group 5a (primary series: CoronaVac) | Experimental | participants will receive a dose of 2-vial presentation of SCB-2019 vaccine Receives: Biological: Candidate vaccine, SCB-2019 |
| Group 5b (primary series: CoronaVac) | Experimental | participants will receive a dose of 3-vial presentation of SCB-2019 vaccine Receives: Biological: Candidate vaccine, SCB-2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15
Measured: Day 15
GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15
Measured: Day 15
GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15
Measured: Day 15
Local and systemic solicited AEs reported within 7 days after study vaccination
Measured: Up to 7 days after each vaccination
Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29
Measured: Up to Day 29
SAEs, AEs leading to early termination from the study, MAAEs, and AESIs
Measured: Through study completion, an average of 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start13 Jun 2022
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clover Biopharmaceuticals AUS Pty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188677
- Sponsor's protocol ID
- CLO-SCB-2019-015
- Status last verified
- Aug 2023
- First submitted
- 10 Jan 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37439701
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05188677
- Acronym / sponsor ID
- CLO-SCB-2019-015
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,831 participants (actual)
- Lead sponsor
- Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Group 1a (primary series: Comirnaty) | Experimental | Biological: Candidate vaccine, SCB-2019participants will receive one dose of SCB-2019 vaccine on Day 1 |
| Group 1b (primary series: Comirnaty) | Active comparator | Biological: Comirnaty Vaccineparticipants will receive one dose of Comirnaty vaccine on Day 1 |
| Group 2a (primary series: Vaxzevria) | Experimental | Biological: Candidate vaccine, SCB-2019participants will receive one dose of SCB-2019 vaccine on Day 1 |
| Group 2b (primary series: Vaxzevria) | Active comparator | Biological: Vaxzevria Vaccineparticipants will receive one dose of Vaxzevria vaccine on Day 1 |
| Group 3a (primary series: CoronaVac) | Experimental | Biological: Candidate vaccine, SCB-2019participants will receive one dose of SCB-2019 vaccine on Day 1 |
| Group 3b (primary series: CoronaVac) | Active comparator | Biological: CoronaVac Vaccineparticipants will receive one dose of CoronaVac vaccine on Day 1 |
| Group 4a (primary series and booster dose CoronaVac) | Experimental | Biological: Candidate vaccine, SCB-2019participants will receive one dose of SCB-2019 vaccine on Day 1 |
| Group 4b (primary series and booster dose CoronaVac) | Active comparator | Biological: CoronaVac Vaccineparticipants will receive one dose of CoronaVac on Day 1; |
| Group 4c (primary series and booster dose CoronaVac) | Experimental | Biological: Candidate vaccine, SCB-2019participants will receive a half dose of SCB-2019 vaccine on Day 1 |
| Group 5a (primary series: CoronaVac) | Experimental | Biological: Candidate vaccine, SCB-2019participants will receive a dose of 2-vial presentation of SCB-2019 vaccine |
| Group 5b (primary series: CoronaVac) | Experimental | Biological: Candidate vaccine, SCB-2019participants will receive a dose of 3-vial presentation of SCB-2019 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candidate vaccine, SCB-2019a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection | Biological | Group 1a (primary series: Comirnaty), Group 2a (primary series: Vaxzevria), Group 3a (primary series: CoronaVac), Group 4a (primary series and booster dose CoronaVac), Group 4c (primary series and booster dose CoronaVac), Group 5a (primary series: CoronaVac), Group 5b (primary series: CoronaVac) |
| Comirnaty Vaccineintramuscular injection | Biological | Group 1b (primary series: Comirnaty) |
| Vaxzevria Vaccineintramuscular injection | Biological | Group 2b (primary series: Vaxzevria) |
| CoronaVac Vaccineintramuscular injection | Biological | Group 3b (primary series: CoronaVac), Group 4b (primary series and booster dose CoronaVac) |
Primary outcome
GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15
Time frame: Day 15
GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15
Time frame: Day 15
GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15
Time frame: Day 15
Local and systemic solicited AEs reported within 7 days after study vaccination
Time frame: Up to 7 days after each vaccination
Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29
Time frame: Up to Day 29
SAEs, AEs leading to early termination from the study, MAAEs, and AESIs
Time frame: Through study completion, an average of 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 37439701Roa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candidate vaccine, SCB-2019, Comirnaty Vaccine and Vaxzevria Vaccine in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15 (time frame: Day 15). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.