A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)

Summary

This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).

Conditions

• COVID-19

Interventions

BIOLOGICAL

Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen

18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.

BIOLOGICAL

Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen

18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.

BIOLOGICAL

High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen

18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.

BIOLOGICAL

High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen

18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.

BIOLOGICAL

Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen

60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.

BIOLOGICAL

Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen

60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.

BIOLOGICAL

High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen

60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.

BIOLOGICAL

High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen

60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.

BIOLOGICAL

Low-dose placebo (18-59 years) & Two dose regimen

18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.

BIOLOGICAL

Low-dose placebo (18-59 years) & Three dose regimen

18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.

BIOLOGICAL

High-dose placebo (18-59 years) & Two dose regimen

18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.

BIOLOGICAL

High-dose placebo (18-59 years) & Three dose regimen

18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.

BIOLOGICAL

Low-dose placebo (60-85 years) & Two dose regimen

60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.

BIOLOGICAL

Low-dose placebo (60-85 years) & Three dose regimen

60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.

BIOLOGICAL

High-dose placebo (60-85 years) & Two dose regimen

60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.

BIOLOGICAL

High-dose placebo (60-85 years) & Three dose regimen

60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• 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

2020-11-17

Primary Completion

2021-02-18

Completion

2021-11-23

Countries

• China

Study Locations