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

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.

Conditions

• COVID-19

Interventions

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

Sponsors & Collaborators

• West China Second University Hospital

  collaborator OTHER

• Yunnan Center for Disease Control and Prevention

  collaborator OTHER

• Institute of Medical Biology, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Qin Yu · West China Second University Hospital

• Xiaoqiang Liu · Yunnan 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

2020-05-15

Primary Completion

2020-08-10

Completion

2021-08-31

Countries

• China

Study Locations