NCT04352608

Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)

A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 744 (actual)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged 18\~59 Years.

Detailed description

This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18\~59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ. All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28 and one dose of booster immunization will be given 6 months after primary immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or 0,28,56 .

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule	Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
BIOLOGICAL	Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule	Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
BIOLOGICAL	Two doses of placebo at the emergency vaccination schedule	Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.
BIOLOGICAL	Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule	Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.
BIOLOGICAL	Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule	Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ
BIOLOGICAL	Two doses of placebo at the routine vaccination schedule	Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.
BIOLOGICAL	Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule	Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
BIOLOGICAL	Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule	Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
BIOLOGICAL	Three doses of placebo at the emergency vaccination schedule	Three doses of placebo at the schedule of day 0,14,42
BIOLOGICAL	Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule	Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
BIOLOGICAL	Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule	Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
BIOLOGICAL	Three doses of placebo at the routine vaccination schedule	Three doses of placebo at the schedule of day 0,28,56

Timeline

• Start date: 2020-04-16
• Primary completion: 2020-07-10
• Completion: 2021-07-24
• First posted: 2020-04-20
• Last updated: 2022-02-24

Locations

1 site across 1 country: China