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

NCT05408312 | Completed Phase 1

• 1 other identifier: CXSL2200156-Ⅰ
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19 Pneumonia

Keywords

COVID-19

Outcome Measures

Primary Outcomes (15)

• The incidence rate of any adverse reactions/events

  within 30 minutes after vaccination

• The incidence severity of any adverse reactions/events

  within 30 minutes after vaccination

• the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine

  on the 4th day after each dose of vaccination

• The incidence rate of solicited adverse reactions/events

  within 0-7 days after vaccination

• The incidence severity of solicited adverse reactions/events

  within 0-7 days after vaccination

• The incidence rate of solicited adverse reactions/events

  within 8-30 days after vaccination

• The incidence severity of solicited adverse reactions/events

  within 8-30 days after vaccination

• Incidence of adverse events leading to withdrawal

  within 8-30 days after vaccination

• Severity of adverse events leading to withdrawal

  within 8-30 days after vaccination

• The incidence of SAE observed

  up to 12 months after full course of immunization

• The incidence of AESI observed

  up to 12 months after full course of immunization

• Neutralizing antibody level against SARS-CoV-2 GMT

  Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization

• Neutralizing antibody level against SARS-CoV-2 IgG antibody GMC

  Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization

• Neutralizing antibody level against SARS-CoV-2 positive rate

  Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization

• Neutralizing antibody level against SARS-CoV-2 Positive conversion rate

  Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization

Secondary Outcomes (2)

• GMT of GEN2-Recombinant COVID-19 Vaccine (CHO cells, NVSI-06-08) against VOC in healthy people aged 18 and above

  after the full course of immunization

• Cellular immune response level of subjects aged 18-59

  Before the first vaccination ， 15 days after the full course of immunization

Study Arms (4)

Experimental group 1

EXPERIMENTAL

Biological: Experimental Vaccine 1

Experimental group 2

EXPERIMENTAL

Biological: Experimental Vaccine 2

Experimental group 3

EXPERIMENTAL

Biological: Experimental Vaccine 3

placebo group

PLACEBO COMPARATOR

Biological: placebo

Interventions

Experimental Vaccine 1 BIOLOGICAL

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

Experimental group 1

Experimental Vaccine 2 BIOLOGICAL

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

Experimental group 2

Experimental Vaccine 3 BIOLOGICAL

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

Experimental group 3

placebo BIOLOGICAL

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

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: healthy people aged 18 and above, who can provide legal identification;
• No history of t SARS-CoV-2 vaccination;
• Able to provide a negative nucleic acid test certificate for the new coronavirus within 48 hours;
• Have the ability to understand (if illiterate, a fair witness is required to accompany the informed consent) research procedures, have informed consent, voluntarily sign the informed consent form, and be able to comply with the requirements of the clinical research protocol；
• Inquire about medical history and physical examination, and the investigator judges that the health status is good;
• Females of childbearing age (menarche to menopause) were not pregnant (negative urine pregnancy test) at enrollment, were not breastfeeding, and had no reproductive plans within the first 6 months after enrollment and took effective contraceptive measures; 2 weeks prior to enrollment have taken effective contraceptive measures;
• Able and willing to complete the entire prescribed study plan throughout the study follow-up period.

You may not qualify if:

• Confirmed cases, suspected cases, asymptomatic infections, or close contacts of the above-mentioned groups of SARS-CoV-2 infection (check "China Disease Prevention and Control Information System");
• Axillary body temperature ≥37.3℃ before vaccination;
• Positive test for novel coronavirus antibody (IgG+IgM);
• Have a history of SARS virus infection (self-report, on-site inquiry);
• Fever (axillary temperature ≥37.3℃), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before vaccination;
• The test results of blood biochemistry, blood routine, urine routine and coagulation function-related indexes before vaccination are abnormal, which are beyond the reference value range and have clinically significant abnormalities;
• Severe allergic reactions (such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain) have occurred in the past;
• Allergy to any component of the study vaccine (such as: aluminum, histidine, etc.);
• Patients with convulsions, epilepsy, encephalopathy or other progressive neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.), long-term history of alcohol and drug abuse, history of thyroidectomy, infectious diseases, mental illness medical or family history;
• Known or suspected diseases include: severe respiratory disease, severe liver and kidney disease, severe cardiovascular disease, uncontrolled hypertension (systolic blood pressure ≥140mmHg, diastolic blood pressure ≥90mmHg), diabetic complications, malignant tumors, Various acute diseases, acute exacerbations of chronic diseases or severe chronic diseases;
• Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
• Thrombocytopenia, history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
• Asplenia or splenectomy, functional asplenia caused by any circumstance;
• Are receiving anti-TB (tuberculosis) treatment;
• Received immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days);

Sponsors & Collaborators

• National Vaccine and Serum Institute, China: lead
• Lanzhou Institute of Biological Products Co., Ltd: collaborator
• Beijing Institute of Biological Products Co Ltd.: collaborator

Study Sites (1)

Ning ling Center for Disease Control and Prevention

Shangqiu, Henan, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 7, 2022
• Study Start: June 18, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)