MedTrace Logo

Phase I Clinical Trial of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above

NCT05408312 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-01-16

No results posted yet for this study

Summary

phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older.

A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.

Conditions

Interventions

BIOLOGICAL

Experimental Vaccine 1

Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm

BIOLOGICAL

Experimental Vaccine 2

Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm

BIOLOGICAL

Experimental Vaccine 3

Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm

BIOLOGICAL

placebo

Intramuscular injection of low-dose Recombinant placebo in the deltoid muscle of the upper arm

Sponsors & Collaborators

  • Lanzhou Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • National Vaccine and Serum Institute, China

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-18
Primary Completion
2024-02-28
Completion
2024-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408312 on ClinicalTrials.gov