NCT04412538

Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19

A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 942 (actual)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged 18\~59 Years.

Detailed description

This phase Ia/IIa trial is designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules based upon the randomized, double-blind and placebo-controlled principle. A total of 942 subjects aged 18 to 59 years old will be enrolled in the study, of which 192 and 750 will be enrolled for phase Ia and phase Ⅱa,respectively.The enrolled subjects in phase Ia receive two doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 14 or 28 days, while the enrolled subjects in Phase Ⅱa receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 14 or 28 days.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule	Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
BIOLOGICAL	Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule	Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
BIOLOGICAL	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule	Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
BIOLOGICAL	Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule	Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
BIOLOGICAL	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule	Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
BIOLOGICAL	High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule	Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
BIOLOGICAL	Placebo on a 0- and 28-day schedule	Two doses of placebo at the vaccination schedule of day 0,28
BIOLOGICAL	Placebo on a 0- and 14-day schedule	Two doses of placebo at the vaccination schedule of day 0,14

Timeline

• Start date: 2020-05-15
• Primary completion: 2020-08-10
• Completion: 2021-08-31
• First posted: 2020-06-02
• Last updated: 2023-10-11

Locations

1 site across 1 country: China