COVID-19Phase 2/3NCT05193279

Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age

A Phase 2/3 study testing Candidate vaccine, SCB-2019 in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 2 sites in Colombia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This is a phase 2/3, randomized, controlled study to assess the reactogenicity, safety and immunogenicity of adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019), when administered as 2-dose vaccination series in children below 18 years of age. Read more about this study

Who is it for?: Ages Up to 17 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Candidate vaccine, SCB-2019
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 2 sitesColombia
Study dates: 5 Oct 2022to 15 Dec 2022
Phase: Phase 2/3
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 Up to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female <18 years of age. Participants will be stratified into different age cohorts (≥12 to < 18 years, ≥5 to < 12 years, ≥2 to < 5 years, and < 2 years of age) based on the age on the day of inclusion.
Individuals and their legally authorized representative (LAR) are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
Individuals are willing and able to give an assent (if applicable) and their LARs are willing and able to give informed consent on their behalf, prior to screening
Healthy participants (phase 2 and phase 3) or participants with pre-existing medical conditions who are in a stable medical condition (phase 2)
For infants (<1-year-old) - born at full term (gestational age ≥37 weeks) and with a normal birth weight (≥2500 grams).
Female participants of childbearing potential may be enrolled in the study, if the participant has practiced highly effective contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination and has agreed to continue adequate contraception for 3 months after the last vaccination

Who cannot join

Individuals with fever >38.0°C [≥ 100.4°F] (irrespective of method used), or any acute illness at baseline (Day 1) or within 3 days prior to randomization.
Individuals with laboratory-confirmed SARS-CoV-2 infection [as defined by Rapid COVID Antigen Test or an equivalent at Day 1] or with history of laboratory-confirmed/medically-diagnosed COVID-19 (for phase 2 participants only).
Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1, or plan to receive an investigational or licensed COVID-19 vaccine during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease [e.g., malignancy, human immunodeficiency virus (HIV) infection] or immunosuppressive/cytotoxic therapy (e.g., systemic corticosteroids, medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 3 months prior to Day 1. Inhaled, intranasal, topical steroids as well as a single dose of systemic steroids, are allowed.
Individuals with any progressive or severe neurologic disorder, seizure disorder (including febrile seizures) or history of Guillain-Barré syndrome.
Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.

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Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction
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.
Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 28 days after the second (phase 2) or third (phase 3) vaccination.
Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection
Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period
Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

Clínica de la Costa Ltda
Barranquilla, 080020
Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S.
Cali

Other trials in Colombia

About this study

Official title: A Randomized, Controlled, Dose-finding, Observer-blind, Phase 2/3 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of CpG/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccines (SCB-2019 Vaccine) in Children <18 Years of Age

Conditions: COVID-19
Being tested: Candidate vaccine, SCB-2019
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

Study groups in NCT05193279
Study group	Role	What they receive
SCB-2019/SCB-2019/placebo, 12 to < 18 yrs	Experimental	Day 1 and 22: SCB-2019, Day 43: placebo Receives: Biological: Candidate vaccine, SCB-2019
Placebo/SCB-2019/SCB-2019, 12 to < 18 years	Experimental	Day 1: placebo, Day 22 and 43: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
SCB-2019/placebo/SCB-2019, 12 to < 18 years	Experimental	Day 1 and 43: SCB-2019, Day 22: placebo Receives: Biological: Candidate vaccine, SCB-2019
Low dose SCB-2019, 5 to < 12 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
Mid dose SCB-2019, 5 to < 12 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
High dose SCB-2019, 5 to < 12 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
SCB-2019/SCB-2019/placebo, 5 to < 12 yrs	Experimental	Day 1 and 22: SCB-2019, Day 43: placebo Receives: Biological: Candidate vaccine, SCB-2019
Placebo/SCB-2019/SCB-2019, 5 to < 12 years	Experimental	Day 1: placebo, Day 22 and 43: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
SCB-2019/placebo/SCB-2019, 5 to < 12 years	Experimental	Day 1 and 43: SCB-2019, Day 22: placebo Receives: Biological: Candidate vaccine, SCB-2019
Low dose SCB-2019, 2 to < 5 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
Mid dose SCB-2019, 2 to < 5 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
High dose SCB-2019, 2 to < 5 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
SCB-2019/SCB-2019/placebo, 2 to < 5 yrs	Experimental	Day 1 and 22: SCB-2019, Day 43: placebo Receives: Biological: Candidate vaccine, SCB-2019
Placebo/SCB-2019/SCB-2019, 2 to < 5 years	Experimental	Day 1: placebo, Day 22 and 43: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
SCB-2019/placebo/SCB-2019, 2 to < 5 years	Experimental	Day 1 and 43: SCB-2019, Day 22: placebo Receives: Biological: Candidate vaccine, SCB-2019
Low dose SCB-2019, birth to < 2 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
Mid dose SCB-2019, birth to < 2 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
High dose SCB-2019, birth to < 2 years	Experimental	Day 1 and 22: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
SCB-2019/SCB-2019/placebo, birth to < 2 yrs	Experimental	Day 1 and 22: SCB-2019, Day 43: placebo Receives: Biological: Candidate vaccine, SCB-2019
Placebo/SCB-2019/SCB-2019, birth to < 2 years	Experimental	Day 1: placebo, Day 22 and 43: SCB-2019 Receives: Biological: Candidate vaccine, SCB-2019
SCB-2019/placebo/SCB-2019, birth to < 2 years	Experimental	Day 1 and 43: SCB-2019, Day 22: placebo Receives: Biological: Candidate vaccine, SCB-2019

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
Proportion of subjects with solicited local and systemic adverse events
Measured: 7 days after dose 1 (Day 1-7)
Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
Proportion of subjects with solicited local and systemic adverse events
Measured: 7 days after dose 2 (Day 22-28)
Phase 2, select optimal dose level of SCB-2019 vaccine in phase 2 by age cohort (5-11 years, 2-4 years, and < 2 years), based on immunogenicity
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb)
Measured: Day 36
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 5 to 12 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study
Measured: 21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 2 to 5 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study
Measured: 21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants birth to 2 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study
Measured: 21/15 days after second SCB-2019 dose

Secondary outcomes (14)

Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
Proportion of participants achieving seroconversion for SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 5 to < 12 years minus proportion in participants 18 to < 25 years from CLO-SCB-2019-003 study
Measured: 21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
Proportion of participants achieving seroconversion for SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 2 to < 5 years minus proportion in participants 18 to < 25 years from CLO-SCB-2019-003 study
Measured: 21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
Proportion of participants achieving seroconversion for SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants birth to < 2 years minus proportion in participants 18 to < 25 years from CLO-SCB-2019-003 study
Measured: 21/15 days after second SCB-2019 dose
In phase 2 and 3, GMT of SARS-CoV-2 nAb
Measured: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants achieving seroconversion for SARS-CoV-2 nAb
Measured: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, GMFR in SARS-CoV-2 nAb
Measured: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants with SARS-CoV-2 nAb above a certain threshold
Measured: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, GMT of SCB-2019 Binding Antibody
Measured: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants achieving seroconversion for SCB-2019 binding antibody
Measured: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, GMFR of SCB-2019 binding antibody
Measured: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants with SCB-2019 binding antibody above a certain threshold
Measured: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 3, reactogenicity of the vaccine as indicated by the occurrence of solicited local and systemic reactions
In phase 3, proportion of participants with local and systemic AEs
Measured: 7 days after dose 1 (Day 1-7), dose 2 (Day 22-Day 28) and Dose 3 (Day 43-49)
Phase 2 and 3, safety of the vaccine in terms of occurrence of unsolicited adverse events
Proportion of subjects with unsolicited adverse events
Measured: Up to 21 days after the last vaccination
Phase 2 and 3, safety of the vaccine in terms of occurrence of MAAEs, SAEs, adverse events leading to discontinuation from study, and AESIs.
Proportion of participants with any adverse events in this category.
Measured: During the entire study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202215 Dec 2022

First posted14 Jan 2022
Study start5 Oct 2022
Primary completion15 Dec 2022
Study completion15 Dec 2022

Why it stopped: The study was terminated during the EC submission process prior to the enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05193279
Sponsor's protocol ID: CLO-SCB-2019-007
Status last verified: Mar 2023
First submitted: 23 Dec 2021
Last updated: 24 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Dose-finding, Observer-blind, Phase 2/3 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of CpG/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccines (SCB-2019 Vaccine) in Children <18 Years of Age
ClinicalTrials.gov ID: NCT05193279
Acronym / sponsor ID: CLO-SCB-2019-007
Conditions: COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The study was terminated during the EC submission process prior to the enrollment.
Enrolment: 0 participants (actual)
Lead sponsor: Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
Study start: 5 Oct 2022 (actual)
Primary completion: 15 Dec 2022 (actual)
Study completion: 15 Dec 2022 (actual)
First posted: 14 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 21

Arm	Type	Receives
SCB-2019/SCB-2019/placebo, 12 to < 18 yrs	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, 12 to < 18 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, 12 to < 18 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 43: SCB-2019, Day 22: placebo
Low dose SCB-2019, 5 to < 12 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
Mid dose SCB-2019, 5 to < 12 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
High dose SCB-2019, 5 to < 12 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
SCB-2019/SCB-2019/placebo, 5 to < 12 yrs	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, 5 to < 12 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, 5 to < 12 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 43: SCB-2019, Day 22: placebo
Low dose SCB-2019, 2 to < 5 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
Mid dose SCB-2019, 2 to < 5 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
High dose SCB-2019, 2 to < 5 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
SCB-2019/SCB-2019/placebo, 2 to < 5 yrs	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, 2 to < 5 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, 2 to < 5 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 43: SCB-2019, Day 22: placebo
Low dose SCB-2019, birth to < 2 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
Mid dose SCB-2019, birth to < 2 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
High dose SCB-2019, birth to < 2 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019
SCB-2019/SCB-2019/placebo, birth to < 2 yrs	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 22: SCB-2019, Day 43: placebo
Placebo/SCB-2019/SCB-2019, birth to < 2 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1: placebo, Day 22 and 43: SCB-2019
SCB-2019/placebo/SCB-2019, birth to < 2 years	Experimental	Biological: Candidate vaccine, SCB-2019Day 1 and 43: SCB-2019, Day 22: placebo

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Male or female <18 years of age. Participants will be stratified into different age cohorts (≥12 to < 18 years, ≥5 to < 12 years, ≥2 to < 5 years, and < 2 years of age) based on the age on the day of inclusion.
Individuals and their legally authorized representative (LAR) are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
Individuals are willing and able to give an assent (if applicable) and their LARs are willing and able to give informed consent on their behalf, prior to screening
Healthy participants (phase 2 and phase 3) or participants with pre-existing medical conditions who are in a stable medical condition (phase 2)
For infants (<1-year-old) - born at full term (gestational age ≥37 weeks) and with a normal birth weight (≥2500 grams).

Key exclusion criteria (12 listed)

Individuals with fever >38.0°C [≥ 100.4°F] (irrespective of method used), or any acute illness at baseline (Day 1) or within 3 days prior to randomization.
Individuals with laboratory-confirmed SARS-CoV-2 infection [as defined by Rapid COVID Antigen Test or an equivalent at Day 1] or with history of laboratory-confirmed/medically-diagnosed COVID-19 (for phase 2 participants only).
Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1, or plan to receive an investigational or licensed COVID-19 vaccine during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease [e.g., malignancy, human immunodeficiency virus (HIV) infection] or immunosuppressive/cytotoxic therapy (e.g., systemic corticosteroids, medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 3 months prior to Day 1. Inhaled, intranasal, topical steroids as well as a single dose of systemic steroids, are allowed.
Individuals with any progressive or severe neurologic disorder, seizure disorder (including febrile seizures) or history of Guillain-Barré syndrome.

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	Biological	High dose SCB-2019, 2 to < 5 years, High dose SCB-2019, 5 to < 12 years, High dose SCB-2019, birth to < 2 years, Low dose SCB-2019, 2 to < 5 years, Low dose SCB-2019, 5 to < 12 years, Low dose SCB-2019, birth to < 2 years, Mid dose SCB-2019, 2 to < 5 years, Mid dose SCB-2019, 5 to < 12 years, Mid dose SCB-2019, birth to < 2 years, Placebo/SCB-2019/SCB-2019, 12 to < 18 years, Placebo/SCB-2019/SCB-2019, 2 to < 5 years, Placebo/SCB-2019/SCB-2019, 5 to < 12 years, Placebo/SCB-2019/SCB-2019, birth to < 2 years, SCB-2019/SCB-2019/placebo, 12 to < 18 yrs, SCB-2019/SCB-2019/placebo, 2 to < 5 yrs, SCB-2019/SCB-2019/placebo, 5 to < 12 yrs, SCB-2019/SCB-2019/placebo, birth to < 2 yrs, SCB-2019/placebo/SCB-2019, 12 to < 18 years, SCB-2019/placebo/SCB-2019, 2 to < 5 years, SCB-2019/placebo/SCB-2019, 5 to < 12 years, SCB-2019/placebo/SCB-2019, birth to < 2 years

Primary outcome

Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
Time frame: 7 days after dose 1 (Day 1-7)
Proportion of subjects with solicited local and systemic adverse events
Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety
Time frame: 7 days after dose 2 (Day 22-28)
Proportion of subjects with solicited local and systemic adverse events
Phase 2, select optimal dose level of SCB-2019 vaccine in phase 2 by age cohort (5-11 years, 2-4 years, and < 2 years), based on immunogenicity
Time frame: Day 36
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb)
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
Time frame: 21/15 days after second SCB-2019 dose
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 5 to 12 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
Time frame: 21/15 days after second SCB-2019 dose
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 2 to 5 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study
Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
Time frame: 21/15 days after second SCB-2019 dose
GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants birth to 2 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study

14 secondary outcomes

Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years)
Time frame: 21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years)
Time frame: 21/15 days after second SCB-2019 dose
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years)
Time frame: 21/15 days after second SCB-2019 dose
In phase 2 and 3, GMT of SARS-CoV-2 nAb
Time frame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants achieving seroconversion for SARS-CoV-2 nAb
Time frame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, GMFR in SARS-CoV-2 nAb
Time frame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants with SARS-CoV-2 nAb above a certain threshold
Time frame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, GMT of SCB-2019 Binding Antibody
Time frame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants achieving seroconversion for SCB-2019 binding antibody
Time frame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, GMFR of SCB-2019 binding antibody
Time frame: Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)
In phase 2 and 3, proportion of participants with SCB-2019 binding antibody above a certain threshold
Time frame: Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)
In phase 3, reactogenicity of the vaccine as indicated by the occurrence of solicited local and systemic reactions
Time frame: 7 days after dose 1 (Day 1-7), dose 2 (Day 22-Day 28) and Dose 3 (Day 43-49)
Phase 2 and 3, safety of the vaccine in terms of occurrence of unsolicited adverse events
Time frame: Up to 21 days after the last vaccination
Phase 2 and 3, safety of the vaccine in terms of occurrence of MAAEs, SAEs, adverse events leading to discontinuation from study, and AESIs.
Time frame: During the entire study period

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.

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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 2/3 study testing Candidate vaccine, SCB-2019 in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 2 sites in Colombia.

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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 24 Mar 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 Colombia. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety (time frame: 7 days after dose 1 (Day 1-7)). 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 NCT05193279.

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 Mar 2023.