AzTrials
AzTrials

COVID-19 PneumoniaPhase 1NCT05408312

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

A Phase 1 study testing Experimental Vaccine 1, Experimental Vaccine 2 and Experimental Vaccine 3 in people with COVID-19 Pneumonia, run by National Vaccine and Serum Institute, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
Experimental Vaccine 1, Experimental Vaccine 2 and Experimental Vaccine 3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
1 siteChina
Study dates
18 Jun 2022to 28 Feb 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • First-dose exclusion criteria：
  • 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;
Show all 26Show fewer
  • 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);
  • Received live attenuated vaccine within 28 days before vaccination, and received other vaccines within 14 days before vaccination;
  • Received blood products within 3 months before vaccination;
  • Received other study drugs within 6 months before vaccination;
  • Planning to move before the end of the study or to be away from the local area for an extended period of time during a scheduled study visit;
  • The investigator judges other circumstances that are not suitable to participate in this clinical trial.
  • Positive urine pregnancy test;
  • Patients with abnormal conditions such as high fever (axillary temperature ≥39.0℃) for three days, convulsions, severe allergic reactions or any adverse reactions of the --Nervous system after the previous dose of vaccination;
  • Serious adverse reactions that are causally related to the previous dose of vaccination;
  • For those newly discovered or newly discovered after the previous dose of vaccine that do not meet the first-dose inclusion criteria or meet the first-dose exclusion criteria, the investigator will determine whether to continue participating in the study;
  • Other reasons for exclusion considered by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ning ling Center for Disease Control and Prevention

    Shangqiu, Henan

Other trials in China

About this study

Official title: Phase I Clinical Trial of Safety, Tolerance and Immunogenicity of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above

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.

Being tested
Experimental Vaccine 1, Experimental Vaccine 2, Experimental Vaccine 3, placebo
Keywords
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental Vaccine 1Biological

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

  • Experimental Vaccine 2Biological

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

  • Experimental Vaccine 3Biological

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

  • placeboBiological

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

Study groups in NCT05408312
Study groupRoleWhat they receive
Experimental group 1ExperimentalNot described
Receives: Biological: Experimental Vaccine 1
Experimental group 2ExperimentalNot described
Receives: Biological: Experimental Vaccine 2
Experimental group 3ExperimentalNot described
Receives: Biological: Experimental Vaccine 3
placebo groupPlacebo comparatorNot described
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence rate of any adverse reactions/events

    Measured: within 30 minutes after vaccination

  2. The incidence severity of any adverse reactions/events

    Measured: within 30 minutes after vaccination

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

    Measured: on the 4th day after each dose of vaccination

  4. The incidence rate of solicited adverse reactions/events

    Measured: within 0-7 days after vaccination

  5. The incidence severity of solicited adverse reactions/events

    Measured: within 0-7 days after vaccination

  6. The incidence rate of solicited adverse reactions/events

    Measured: within 8-30 days after vaccination

  7. The incidence severity of solicited adverse reactions/events

    Measured: within 8-30 days after vaccination

  8. Incidence of adverse events leading to withdrawal

    Measured: within 8-30 days after vaccination

  9. Severity of adverse events leading to withdrawal

    Measured: within 8-30 days after vaccination

  10. The incidence of SAE observed

    Measured: up to 12 months after full course of immunization

  11. The incidence of AESI observed

    Measured: up to 12 months after full course of immunization

  12. Neutralizing antibody level against SARS-CoV-2 GMT

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

  13. Neutralizing antibody level against SARS-CoV-2 IgG antibody GMC

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

  14. Neutralizing antibody level against SARS-CoV-2 positive rate

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

  15. Neutralizing antibody level against SARS-CoV-2 Positive conversion rate

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

Secondary outcomes (2)

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

    Measured: after the full course of immunization

  2. Cellular immune response level of subjects aged 18-59

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start18 Jun 2022
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05408312
Sponsor's protocol ID
CXSL2200156-Ⅰ
Status last verified
Dec 2025
First submitted
5 Jun 2022
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Experimental Vaccine 1, Experimental Vaccine 2 and Experimental Vaccine 3 in people with COVID-19 Pneumonia, run by National Vaccine and Serum Institute, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence rate of any adverse reactions/events (time frame: within 30 minutes after vaccination). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in