Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04932824




Registration number
NCT04932824
Ethics application status
Date submitted
13/04/2021
Date registered
21/06/2021
Date last updated
11/02/2022

Titles & IDs
Public title
Long-term Follow-up to the Phase 1 Study of Adjuvanted SARS-CoV-2 (SCB 2019) Vaccine for COVID-19.
Scientific 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
Secondary ID [1] 0 0
CLO-SCB-2019-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SCB-2019

No intervention: Subjects Without Treatment Cross-over - these subjects will not receive any vaccination during this study.

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)

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.


Treatment: Other: SCB-2019
a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of AESIs and SAEs
Timepoint [1] 0 0
from 6 to 24 months after the 1st vaccination dose
Primary outcome [2] 0 0
Incidence of AESIs and SAEs
Timepoint [2] 0 0
up to 12 months after booster dose
Primary outcome [3] 0 0
Serum anti-SCB-2019 IgG antibody titers
Timepoint [3] 0 0
from 6 to 24 months after the 1st vaccination dose
Primary outcome [4] 0 0
Serum anti-SCB-2019 IgG antibody titers
Timepoint [4] 0 0
up to 12 months after booster dose
Secondary outcome [1] 0 0
Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)
Timepoint [1] 0 0
from 6 to 24 months after the 1st vaccination dose
Secondary outcome [2] 0 0
Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)
Timepoint [2] 0 0
up to 12 months after booster dose

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/12/2021
Sample size
Target
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
Territory WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clover Biopharmaceuticals AUS Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04932824