NCT04445194

Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine

A Multi-center, Double-blind, Randomized, Placebo Parallel Controlled, Safety and Tolerability Phase I Clinical Trial of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Healthy People Between 18 and 59 Years of Age

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.

Detailed description

In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose . The researchers conducted a safety evaluation and agreed to follow-up after discharge. In this trial, all adverse events (AE), all AEs from 0-7 days, and all AEs from 8-30 days will be collected 30 minutes after each dose, and all AEs will be collected from the first dose to 30 days after the entire vaccination, and the first dose will be inoculated to the full course All serious adverse events (SAE) 6 months after vaccination.

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant new coronavirus vaccine (CHO cell) low-dose group	Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
BIOLOGICAL	Recombinant new coronavirus vaccine (CHO cells) high-dose group	Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
BIOLOGICAL	Recombinant new coronavirus vaccine (CHO cells) placebo group	Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Timeline

• Start date: 2020-06-22
• Primary completion: 2020-10-22
• Completion: 2021-09-20
• First posted: 2020-06-24
• Last updated: 2020-12-03

Locations

1 site across 1 country: China