Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT04530656
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Trial of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell)
Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Organization:
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 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 3:1.
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:
True
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?: