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

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.

Conditions

• COVID-19

Interventions

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

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Fengcai Zhu, Doctor · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-16

Primary Completion

2020-07-10

Completion

2021-07-24

Countries

• China

Study Locations