Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)

Summary

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are \>59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

Conditions

• COVID-19

Interventions

BIOLOGICAL

Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14

Two doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14.

BIOLOGICAL

Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28

Three doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.

BIOLOGICAL

Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14

Two doses of high-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHOCell) at the schedule of day 0, 14.

BIOLOGICAL

Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28

Three doses of middle-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.

BIOLOGICAL

Two doses of placebo at the schedule of day 0, 14 #middle-dose group#

Two doses of placebo (0.5ml) at the schedule of day 0, 14.

BIOLOGICAL

Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#

Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.

BIOLOGICAL

Two doses of placebo at the schedule of day 0, 14 #High-dose group#

Two doses of placebo (0.5ml) at the schedule of day 0, 14.

BIOLOGICAL

Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#

Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.

Sponsors & Collaborators

• Academy of Military Medical Sciences，Academy of Military Sciences，PLA

  collaborator UNKNOWN

• ZHONGYIANKE Biotech Co, Ltd.

  collaborator UNKNOWN

• 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

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-30

Primary Completion

2021-12-07

Completion

2022-07-07

Countries

• China

Study Locations