- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04932824
Long-term Follow-up to the Phase 1 Study of Adjuvanted SARS-CoV-2 (SCB 2019) Vaccine for COVID-19.
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
Study Overview
Detailed Description
Once a subject enrolled in the dose-escalation part of study CLO-SCB-2019-001 (groups 1-15) has completed the 6-month visit, 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. For a subject who will receive active vaccine (subjects who received placebo in study CLO-SCB-2019-001) or a booster dose during this long-term study, an additional informed consent form will be signed prior to receiving vaccine.
After study CLO-SCB-2019-001 ends and the treatment assignments are unblinded, those subjects who have received placebo will be given the option to receive 2 doses of active study vaccine 21 days apart (defined as treatment cross-over); subjects who do not consent to vaccination will be discontinued from the study. Subjects who consent to vaccination 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).
Of the subjects that received SCB-2019 CpG/Alum-adjuvanted vaccine in study CLO-SCB-2019-001, the first 24 subjects that agree to receive booster dose will be consented to an additional informed consent form prior to receiving a booster dose and included in this long-term follow-up study. These 24 subjects will be followed up until 12 months after the booster dose.
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Territory Western Australia
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Nedlands, Territory Western Australia, Australia
- Linear Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Subjects Without Treatment Cross-over
these subjects will not receive any vaccination during this study.
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Experimental: 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)
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a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19.
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Experimental: Subjects who will receive Booster Vaccine
For subjects out of those who received SCB-2019 CpG/Alum-adjuvanted vaccine in study CLO-SCB-2019-001: the subjects will receive a booster dose.
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a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of AESIs and SAEs
Time Frame: from 6 to 24 months after the 1st vaccination dose
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To evaluate the safety profile of SCB-2019 up to 24 months after the 1st vaccination dose
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from 6 to 24 months after the 1st vaccination dose
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Incidence of AESIs and SAEs
Time Frame: up to 12 months after booster dose
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To evaluate the safety profile of SCB-2019 up to 12 months after booster dose
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up to 12 months after booster dose
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Serum anti-SCB-2019 IgG antibody titers
Time Frame: from 6 to 24 months after the 1st vaccination dose
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To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 24 months after the 1st vaccination dose
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from 6 to 24 months after the 1st vaccination dose
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Serum anti-SCB-2019 IgG antibody titers
Time Frame: up to 12 months after booster dose
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To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 12 months after booster dose
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up to 12 months after booster dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)
Time Frame: from 6 to 24 months after the 1st vaccination dose
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To describe serum immune responses in terms of antibody titers competitive with binding to ACE2
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from 6 to 24 months after the 1st vaccination dose
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Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)
Time Frame: up to 12 months after booster dose
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To describe serum immune responses in terms of antibody titers competitive with binding to ACE2
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up to 12 months after booster dose
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLO-SCB-2019-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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