Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)

Summary

This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).

Conditions

• COVID-19

Interventions

BIOLOGICAL

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

BIOLOGICAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

BIOLOGICAL

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

BIOLOGICAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

BIOLOGICAL

a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

BIOLOGICAL

a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

BIOLOGICAL

a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

BIOLOGICAL

a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Sponsors & Collaborators

• Academy of Military Medical Sciences，Academy of Military Sciences，PLA ZHONGYIANKE Biotech Co, Ltd. LIAONINGMAOKANGYUAN Biotech Co, Ltd

  collaborator UNKNOWN

• Jiangsu Province Centers for Disease Control and Prevention

  lead NETWORK

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-23

Primary Completion

2022-07-30

Completion

2022-07-30

Countries

• China

Study Locations