A Clinical Trial to Evaluate the Immunogenicity Bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in Healthy Population Aged 18-59 Years
Sponsor study identifier
interventional
1,000
1 country
1
Study Start
July 20, 2022
Actual (reported)Primary Completion
March 11, 2023
Actual (reported)Study Completion
December 30, 2023
Actual (reported)This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2022
Actual (reported)July 20, 2022
Actual (reported)July 20, 2022
Actual (reported)March 11, 2023
Actual (reported)December 30, 2023
Actual (reported)The incidence of adverse reactions(ARs).
The incidence of ARs within 7 days after each vaccination.
Day 0 to day 7
Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).
The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.
Day 72
The incidence of ARs.
Day 0 to Day 72
The incidence of adverse events (AEs).
Day 0 to Day 72
The incidence of serious adverse events (SAEs).
Day 0 to 6 months after the third vaccination.
The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.
Day 72
The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody
Day 72
Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42.
Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21，42.
This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Jiangsu Provincial Center for Disease Control and Prevention
Huai'an, Jiangsu, 210009, China
1,000 participants (actual enrollment reported by the registry).
First Submitted
February 13, 2022
First Posted
July 20, 2022
Study Start
July 20, 2022
Actual (reported)To Evaluate the Immunogenicity and Safety of Sequential Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) for SARS-CoV-2
Contact the study team to confirm eligibility.
Primary Completion
March 11, 2023
Actual (reported)Study Completion
December 30, 2023
Actual (reported)Last Updated
April 24, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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