Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833101
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2021-04-03
Brief Title:
Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine Ad5 Vector and RBD-based Protein Subunit Vaccine
Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Organization:
Jiangsu Province Centers for Disease Control and Prevention
Study Overview
Official Title:
Safety and Immunogenicity of a Heterologous Immunization of Recombinant COVID-19 Vaccine Ad5 Vector and RBD-based Protein Subunit Vaccine Against COVID-19 in Chinese Healthy Population
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized observer-blind placebo-controlled study for evaluation of safety and immunogenicity of heterologous prime-boost immunization of recombinant COVID-19 vaccine adenovirus type-5 vector and RBD-based protein subunit vaccine ZF2001 against COVID-19 in Chinese healthy population 120 healthy subjects aged over 18 years of age who have been vaccinated with recombinant adenovirus type-5 vectored vaccine will be recruited in this study Of them 60 subjects will be enrolled in the 0-28 days regimen and other 60 will be enrolled in 0-56 days regimen Subjects 30 of them are 18-59 years old and 30 are 60 years old and above in each regimen will be randomly vaccinated with the second dose of subunit vaccineZF2001 against COVID-19 or a commercial influenza vaccine in a ratio of 21 They will then be vaccinated with the third dose of ZF2001 on month 4 after the second dose The occurrence of adverse events within 28 days and serious adverse events within 6 months after the last vaccination will be observed In addition blood samples will be collected on day 0 before the second vaccination day 14 28 after the second vaccination and day 14 month 6 after third vaccination to test serum antibody levels and to profile the immune cells subgroups and germlines Each subject will remain in this study for approximately 12 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None