Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04530656
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-08-27
Brief Title:
Phase I Trial of a Recombinant SARS-CoV-2 Vaccine Sf9 Cell
Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Organization:
Jiangsu Province Centers for Disease Control and Prevention
Study Overview
Official Title:
Safety Tolerability and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine Sf9 Cell in Chinese Healthy Population Aged 18 Years and Older A Phase I Single-center Randomized Placebo-controlled Double-blind Study
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 phase I single-center randomized placebo-controlled double-blind study to evaluate safety tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine Sf9 cell in Chinese healthy population aged 18 years and older After randomization the trial for each subject will last for approximately 13 months Screening period is 1 week prior to randomization Day -7 to Day -1 and each dose of either SARS-CoV-2 vaccine Sf9 Cell or placebo will be given intramuscularly IM on Day 0 and Day 28 for a two-dose regimen or on Day 0 Day 14 and Day 28 for a three-dose regimen Subjects who are 18 years old and 55 years old will be enrolled in adult group and healthy elderly population who are 55 years old will be enrolled in elderly group After adult group completes the follow-up 7 days after first vaccination elderly group will be recruited
Detailed Description:
This is a phase I single-center randomized placebo-controlled double-blind study to evaluate safety tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine Sf9 cell in Chinese healthy population aged 18 years and older Healthy adults who are 18 years old and 55 years old will be enrolled in the adult group and healthy elderly population who are 55 years old will be enrolled in the elderly group To ensure the enrollment of healthy subjects screening tests hematology biochemistry and urinalysis will be performed prior to the vaccination In each age group there are three regimen cohort middle-dose at 0 28 schedule high-dose at 0 28 schedule and high-dose at 01428 schedule The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 31
The study will set up an Independent Data Monitoring Committee IDMC to conduct overall supervision The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended
The study will set up an Independent Data Monitoring Committee IDMC to conduct overall supervision The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended
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