NCT04636333

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

Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Healthy adults who are ≥18 years old and ≤59 years old will be enrolled in the adult group and healthy elderly population who are \>59 years old will be enrolled in the elderly group. To ensure the enrollment of healthy subjects, screening tests (hematology, biochemistry, and urinalysis) will be performed prior to the vaccination. In the adults group, there are four regimen cohort: middle-dose at 0, 14 schedule, high-dose at 0, 14 schedule, middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. In the elderly group, there are two regimen cohort: middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1. The study will set up an Independent Data Monitoring Committee (IDMC) to conduct overall supervision. The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-30
• Primary completion: 2021-12-07
• Completion: 2022-07-07
• First posted: 2020-11-19
• Last updated: 2022-03-31

Locations

1 site across 1 country: China