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出境医 / 临床实验 / Long-term Follow-up to the Phase 1 Study of Adjuvanted SARS-CoV-2 (SCB 2019) Vaccine for COVID-19.
Long-term Follow-up to the Phase 1 Study of Adjuvanted SARS-CoV-2 (SCB 2019) Vaccine for COVID-19.
Study Description
Brief Summary:
To develop an effective vaccine against the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, Clover Biopharmaceuticals is conducting a Phase 1 study (CLO-SCB-2019-001) in healthy volunteers to evaluate the safety and immunogenicity of SCB-2019, a recombinant SARS-CoV-2 trimeric Spike protein (S-protein) subunit vaccine. This study, CLO-SCB-2019-002, will be a long-term follow-up study for subjects who have completed CLO-SCB-2019-001 in order to assess longer safety and immunogenicity up to 24 months after the 1st dose of vaccination.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Biological: SCB-2019 | Phase 1 |
Detailed Description:
Once a subject has completed the 6-month visit of study CLO-SCB-2019-001, he/she will enter this study automatically, since subjects were requested to sign the informed consent form for this long term follow-up study at the same time they consent to study CLO-SCB-2019-001.
After study CLO-SCB-2019-001 ends and the treatment assignments are unblinded, those subjects who have received placebo and provided there is active study vaccine available, will be given the option to receive 2 doses of active study vaccine 21 days apart (defined as treatment cross-over). Afterwards they will be followed up until 18 months after the 1st dose of the cross-over vaccination.
Subjects that received SCB-2019 vaccine adjuvanted with AS03 in study CLO-SCB-2019-001 will be followed up for safety only for 12 months after the 1st dose received (V10, day 366).
Statistical methods:
The following descriptive statistics will be used as applicable to summarize the study data unless otherwise specified. Individual subject data will be presented in listings.
- Continuous variables: sample size [n], mean, standard deviation [SD], median, minimum [Min], and maximum [Max].
- Categorical variables: frequencies and percentages. All safety analyses will be performed on the Safety Analysis Set. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) central coding dictionary, version 22.0 (or higher). The percentage of subjects with at least 1 adverse event (AE), adverse event of special interest (AESI), or serious adverse event (SAE) will be tabulated with exact 95% confidence interval (CI) for each treatment and overall. Adverse events/SAEs leading to withdrawal and all pregnancies occurring during the study period will be tabulated with exact 95% CI. The percentage of subjects with at least 1 local AE (solicited and unsolicited), at least 1 general AE (solicited and unsolicited) and any AE will be tabulated, with exact 95% CI. The same computations will be done for Grade 3, any AEs considered related to vaccination, any Grade 3 AEs considered related to vaccination, SAEs and AESIs. Analysis of immunogenicity will be based on the Per Protocol Set. If, at any timepoint, the percentage of vaccinated subjects with serological results excluded from the Per Protocol Set for analysis of immunogenicity is 10% or more, a second analysis based on the Immunogenicity Analysis Set will be performed to complement the Per Protocol Analysis. Observed values and ratio/change from Baseline values (as applicable) will be summarized for each treatment (placebo, vaccine, and with addition of each adjuvant) and at each timepoint where blood samples are collected. Individual data listings of any Coronavirus disease 2019 (COVID-19) cases during the study will be provided. Number of cases that undergo COVID-19 workup as well as the incidence of COVID-19 positive results will be individually listed and summarized using summary statistics per treatment group and per protocol scheduled time point. Time to COVID-19 positive result will also be summarized using Kaplan-Meier methods and the median time to COVID-19 positive result will be estimated and presented with the 95% CIs, if estimable, separately for each treatment group. In addition, clinical risk assessment of COVID-19 at the time of the case workup as assessed by the National Early Warning Score 2 (NEWS2) system will be individually listed and summarized per treatment group.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Long-term Follow-up Study to the Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of SCB-2019, a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19 |
| Actual Study Start Date : | January 19, 2021 |
| Estimated Primary Completion Date : | May 31, 2023 |
| Estimated Study Completion Date : | September 14, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Subjects Without Treatment Cross-over
these subjects will not receive any vaccination during this study.
|
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|
Active Comparator: Subjects With Treatment Cross-over (From 1st Dose of Active Study Vaccine Onwards)
Once the treatment assignments of study CLO-SCB-2019-001 are unblinded, those subjects who have received placebo and provided there is active study vaccine available, will be given the option to receive 2 doses of active study vaccine 21 days apart (ie, treatment cross-over)
|
Biological: SCB-2019
a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19.
|
Outcome Measures
Primary Outcome Measures :
- Number of participants with Adverse Event of Special Interest, (AESIs) [ Time Frame: from 6 to 24 months after the 1st vaccination dose ]To evaluate the safety profile of SCB-2019 up to 24 months after the 1st vaccination dose based on AESIs;
- Number of participants with Serious Adverse Events (SAEs) [ Time Frame: from 6 to 24 months after the 1st vaccination dose ]To evaluate the safety profile of SCB-2019 up to 24 months after the 1st vaccination dose based on SAEs;
- Geometric mean titer (GMT) of serum anti-SCB-2019 IgG antibody titers. [ Time Frame: up to 24 months ]To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 24 months after the 1st vaccination dose;
- Geometric mean fold rise (GMFR) of serum anti-SCB-2019 IgG antibody titers. [ Time Frame: up to 24 months ]To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 24 months after the 1st vaccination dose;
- Seroconversion rate (SCR) of serum anti-SCB-2019 IgG antibody titers. [ Time Frame: up to 24 months ]To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 24 months after the 1st vaccination dose;
Secondary Outcome Measures :
- Geometric mean titer (GMT) of serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based). [ Time Frame: Days 275, 366, 549, and 731. ]To describe serum immune responses in terms of antibody titers competitive with binding to ACE2 (known host cell receptor to SARS-CoV-2 S-protein);
- Geometric mean fold rise (GMFR) of serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based). [ Time Frame: Days 275, 366, 549, and 731. ]To describe serum immune responses in terms of antibody titers competitive with binding to ACE2 (known host cell receptor to SARS-CoV-2 S-protein);
- Seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based). [ Time Frame: Time Frame: Days 275, 366, 549, and 731. ]To describe serum immune responses in terms of antibody titers competitive with binding to ACE2 (known host cell receptor to SARS-CoV-2 S-protein);
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- All subjects from study CLO-SCB-2019-001 will automatically move on to this long-term follow-up study if: 1) They have given informed consent for this follow-up study; and 2) They have completed the D184 visit of study CLO-SCB-2019-001 (ie, 6 months post the 1 st vaccination).
Exclusion Criteria:
- All subjects who did not participate and completed the study or did not signed the inform consent for this follow up study.
Contacts and Locations
Contacts
| Contact: Lara Hatchuel, Doctor | 0863825100 | lhatchuel@linear.org.au | |
| Contact: María del Carmen López, PhD | +525536758124 | maria.carmen@cloverbiopharma.com |
Locations
| Australia, Territory Western Australia | |
| Linear Clinical Research | Recruiting |
| Nedlands, Territory Western Australia, Australia | |
| Contact: Lara Hatchuel, Doctor 0863825100 lhatchuel@linear.org.au | |
Sponsors and Collaborators
Clover Biopharmaceuticals AUS Pty Ltd
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 13, 2021 | ||||||||
| First Posted Date ICMJE | June 21, 2021 | ||||||||
| Last Update Posted Date | June 21, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 19, 2021 | ||||||||
| Estimated Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Long-term Follow-up to the Phase 1 Study of Adjuvanted SARS-CoV-2 (SCB 2019) Vaccine for COVID-19. | ||||||||
| Official Title ICMJE | A Long-term Follow-up Study to the Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of SCB-2019, a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19 | ||||||||
| Brief Summary | To develop an effective vaccine against the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, Clover Biopharmaceuticals is conducting a Phase 1 study (CLO-SCB-2019-001) in healthy volunteers to evaluate the safety and immunogenicity of SCB-2019, a recombinant SARS-CoV-2 trimeric Spike protein (S-protein) subunit vaccine. This study, CLO-SCB-2019-002, will be a long-term follow-up study for subjects who have completed CLO-SCB-2019-001 in order to assess longer safety and immunogenicity up to 24 months after the 1st dose of vaccination. | ||||||||
| Detailed Description |
Once a subject has completed the 6-month visit of study CLO-SCB-2019-001, he/she will enter this study automatically, since subjects were requested to sign the informed consent form for this long term follow-up study at the same time they consent to study CLO-SCB-2019-001. After study CLO-SCB-2019-001 ends and the treatment assignments are unblinded, those subjects who have received placebo and provided there is active study vaccine available, will be given the option to receive 2 doses of active study vaccine 21 days apart (defined as treatment cross-over). Afterwards they will be followed up until 18 months after the 1st dose of the cross-over vaccination. Subjects that received SCB-2019 vaccine adjuvanted with AS03 in study CLO-SCB-2019-001 will be followed up for safety only for 12 months after the 1st dose received (V10, day 366). Statistical methods: The following descriptive statistics will be used as applicable to summarize the study data unless otherwise specified. Individual subject data will be presented in listings.
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | COVID-19 | ||||||||
| Intervention ICMJE | Biological: SCB-2019
a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
150 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 14, 2023 | ||||||||
| Estimated Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Australia | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04932824 | ||||||||
| Other Study ID Numbers ICMJE | CLO-SCB-2019-002 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Clover Biopharmaceuticals AUS Pty Ltd | ||||||||
| Study Sponsor ICMJE | Clover Biopharmaceuticals AUS Pty Ltd | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Clover Biopharmaceuticals AUS Pty Ltd | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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