NCT05013983

Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells) in Children and Adolescents

Single-center, Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells) in Healthy People Aged 6-17 Years

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: WestVac Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).

Detailed description

This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg). The phase Ⅰ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 30 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 120 in total. The phase Ⅱ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 480 in total.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant COVID-19 vaccine (Sf9 cells)	This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
OTHER	Placebo control	Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2021-08-20
• Last updated: 2025-03-28

Locations

1 site across 1 country: China