COVID-19Phase 1/2NCT04869592

A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19

A Phase 1/2 study testing low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) and high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in people with COVID-19, 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

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) and high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,100 participants
Where: 1 siteChina
Study dates: 25 Apr 2021to 29 Aug 2023
Phase: Phase 1/2
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 3 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Age range: healthy people aged 3 years and and older who can provide legal identification;
The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
Inquired about medical history and physical examination, the investigator judged that the health condition is good;
No history of SARS-CoV-2 vaccination before enrollment;
Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;
During the entire study follow-up period, be able and willing to complete the entire prescribed study plan.

Who cannot join

First Dose Exclusion Criteria：
Confirmed cases of SARS-CoV-2 infection, suspected cases, asymptomatic infections, or close contacts with the above population (check "China Disease Prevention and Control Information System");
Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
Positive in SARS-CoV-2 IgG and IgM antibody screening;
Have a history of SARS virus infection (self-report, on-site inquiry);
Fever (axillary temperature is not less than 37.3℃), dry cough, fatigue, nasal, congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, or dyspnea within 14 days before vaccination;

Show all 28Show fewer

Before vaccination, the results of blood biochemistry, blood routine, urine routine, and coagulation function related indexes are abnormal, which exceed the reference value range, and have clinical significance abnormalities (only refers to phase I);
Previous severe allergic reaction to vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain);
Allergic to any component of the study vaccine (such as aluminum, histidine, etc.);
Have a history of convulsions, epilepsy, encephalopathy, long-term alcoholism and drug abuse, thyroidectomy, infectious diseases, mental illness or family history;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
Known or suspected diseases include: severe respiratory disease, severe liver and kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension (systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors, various acute diseases or acute attacks of chronic diseases;
Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
Asthenia or splenectomy, functional asthenia caused by any situation;
Are receiving anti-TB (tuberculosis) treatment;
Have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days);
Have received a live attenuated vaccine within 28 days before vaccination, or received other vaccines within 14 days before vaccination;
Have received blood products within 3 months before vaccination;
Have received other study drugs within 6 months before vaccination;
Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
Other conditions considered by the investigator to be inappropriate for participation in the study.
Exclusion criteria for the second and third doses of vaccination
Positive urine pregnancy test;
Have a high fever (axillary temperature is not less than 39.0℃) for three days and severe allergic reaction after the previous dose of vaccination;
Severe adverse reactions that are causally related to the previous dose of vaccination;
For those newly discovered or newly identified after the previous dose of vaccine that does not meet the first dose selection criteria or meets the first dose exclusion criteria, the investigator will determine whether to continue participating in the study;
Other exclusion reasons 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/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy People Aged 3 Years and Older

phase I study will evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 3 years and older. 300 subjects will be enrolled and divided into 5 age groups: 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group and 3-8 years old group. In each group, there are two regimen cohort: low-dose at 0,30, 60 schedule and high-dose at 0,30,60 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1.

Phase II clinical study will explore dose and immunization procedures in 5 age groups, including 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group, and 3-8 years old group, with a total of 3280 subjects.

Conditions: COVID-19
Being tested: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell), high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell), 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.

low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)Biological
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)Biological
Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
placeboBiological
Intramuscular injection of placebo in the deltoid muscle of the upper arm

Study groups in NCT04869592
Study group	Role	What they receive
Phase 1 low-dose group	Experimental	Not described Receives: Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 1 high-dose group	Experimental	Not described Receives: Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 1 placebo group	Placebo comparator	Not described Receives: Biological: placebo
Phase 2 low-dose group A	Experimental	Not described Receives: Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 low-dose group B	Experimental	Not described Receives: Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 low-dose group C	Experimental	Not described Receives: Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 low-dose group D	Experimental	Not described Receives: Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group A	Experimental	Not described Receives: Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group B	Experimental	Not described Receives: Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group C	Experimental	Not described Receives: Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group D	Experimental	Not described Receives: Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 placebo group A	Placebo comparator	Not described Receives: Biological: placebo
Phase 2 placebo group B	Placebo comparator	Not described Receives: Biological: placebo
Phase 2 placebo group C	Placebo comparator	Not described Receives: Biological: placebo
Phase 2 placebo group D	Placebo comparator	Not described Receives: Biological: placebo

What is being measured

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

the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Phase 1
Measured: through 30 minutes after each dose
the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination
Phase 1
Measured: 4th day each dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Phase 1
Measured: through 7 days after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Phase 1
Measured: through 30 days after each dose
the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination
Phase 1
Measured: through 30 days after each dose
the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination
Phase 1
Measured: up to 12 months after the full course of vaccination
the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination
Phase 1
Measured: up to 12 months after the full course of vaccination
Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination
Phase 1
Measured: 15th day after the full course of vaccination
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Phase 2
Measured: through 30 minutes after each dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Phase 2
Measured: through 7 days after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Phase 2
Measured: through 30 days after each dose
the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination
Phase 2
Measured: through 40 days after each dose
the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination
Phase 2
Measured: through 60 days after each dose
the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination
Phase 2
Measured: through 30 days after each dose
the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination
Phase 2
Measured: through 40 days after each dose
the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination
Phase 2
Measured: through 60 days after each dose
the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination
Phase 2
Measured: up to 12 months after the full course of vaccination
the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination
Phase 2
Measured: up to 12 months after the full course of vaccination
Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination
Phase 2
Measured: 15th day after the full course of vaccination

Secondary outcomes (11)

Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Live SARS-CoV-2 neutralization assay) On the 30th day after the full course of vaccination, the neutralizing antibody level (wild Strains)
Phase 1
Measured: 30th day after the full course of vaccination
Seroconversion and Geometric Mean Titer (GMT) of SARS-CoV-2-Specific Binding Antibody (IgG) Before each dose, the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after full course of vaccination
Phase 1
Measured: before each dose , the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old group before each dose and on the 15th and 30th day after the full course of vaccination
Phase 1
Measured: before each dose，the 15th, 30th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-COV-2 specific neutralizing antibody (live SARS-CoV-2 neutralization assay)) On the 30th day after the full course of vaccination
Phase 2
Measured: 30th day after the full course of vaccination
Two-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Measured: before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Two-dose group: Seroconversion before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Measured: before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Two-dose group: Binding Antibody (IgG) before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Measured: before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Measured: before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group:Seroconversion before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Measured: before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group:Binding Antibody (IgG) before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Measured: before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old 0,30,60 group before each dose , the 15th and 30th day after the full course of vaccination
Phase 2
Measured: before each dose, 15th, 30th day after the full course of vaccination

Timeline

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

25 Apr 202129 Aug 2023

First posted3 May 2021
Study start25 Apr 2021
Primary completion29 Aug 2023
Study completion29 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04869592
Sponsor's protocol ID: 2021-YM-006-02
Status last verified: Dec 2025
First submitted: 24 Apr 2021
Last updated: 16 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy People Aged 3 Years and Older
ClinicalTrials.gov ID: NCT04869592
Acronym / sponsor ID: 2021-YM-006-02
Conditions: COVID-19
Keywords: COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,100 participants (actual)
Lead sponsor: National Vaccine and Serum Institute, ChinaIndustry (pharma, biotech, devices)
Collaborators: Lanzhou Institute of Biological Products Co., Ltd, Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd., Zhengzhou University
Study start: 25 Apr 2021 (actual)
Primary completion: 29 Aug 2023 (actual)
Study completion: 29 Aug 2023 (actual)
First posted: 3 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 15

Arm	Type	Receives
Phase 1 low-dose group	Experimental	Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 1 high-dose group	Experimental	Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 1 placebo group	Placebo comparator	Biological: placebo
Phase 2 low-dose group A	Experimental	Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 low-dose group B	Experimental	Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 low-dose group C	Experimental	Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 low-dose group D	Experimental	Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group A	Experimental	Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group B	Experimental	Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group C	Experimental	Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 high-dose group D	Experimental	Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Phase 2 placebo group A	Placebo comparator	Biological: placebo
Phase 2 placebo group B	Placebo comparator	Biological: placebo
Phase 2 placebo group C	Placebo comparator	Biological: placebo
Phase 2 placebo group D	Placebo comparator	Biological: placebo

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Age range: healthy people aged 3 years and and older who can provide legal identification;
The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
Inquired about medical history and physical examination, the investigator judged that the health condition is good;
No history of SARS-CoV-2 vaccination before enrollment;
Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;

Key exclusion criteria (28 listed)

First Dose Exclusion Criteria：
Confirmed cases of SARS-CoV-2 infection, suspected cases, asymptomatic infections, or close contacts with the above population (check "China Disease Prevention and Control Information System");
Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
Positive in SARS-CoV-2 IgG and IgM antibody screening;
Have a history of SARS virus infection (self-report, on-site inquiry);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm	Biological	Phase 1 low-dose group, Phase 2 low-dose group A, Phase 2 low-dose group B, Phase 2 low-dose group C, Phase 2 low-dose group D
high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm	Biological	Phase 1 high-dose group, Phase 2 high-dose group A, Phase 2 high-dose group B, Phase 2 high-dose group C, Phase 2 high-dose group D
placeboIntramuscular injection of placebo in the deltoid muscle of the upper arm	Biological	Phase 1 placebo group, Phase 2 placebo group A, Phase 2 placebo group B, Phase 2 placebo group C, Phase 2 placebo group D

Primary outcome

the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Time frame: through 30 minutes after each dose
Phase 1
the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination
Time frame: 4th day each dose
Phase 1
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Time frame: through 7 days after each dose
Phase 1
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Time frame: through 30 days after each dose
Phase 1
the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination
Time frame: through 30 days after each dose
Phase 1
the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination
Time frame: up to 12 months after the full course of vaccination
Phase 1
the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination
Time frame: up to 12 months after the full course of vaccination
Phase 1
Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination
Time frame: 15th day after the full course of vaccination
Phase 1
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Time frame: through 30 minutes after each dose
Phase 2
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Time frame: through 7 days after each dose
Phase 2
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Time frame: through 30 days after each dose
Phase 2
the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination
Time frame: through 40 days after each dose
Phase 2
the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination
Time frame: through 60 days after each dose
Phase 2
the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination
Time frame: through 30 days after each dose
Phase 2
the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination
Time frame: through 40 days after each dose
Phase 2
the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination
Time frame: through 60 days after each dose
Phase 2
the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination
Time frame: up to 12 months after the full course of vaccination
Phase 2
the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination
Time frame: up to 12 months after the full course of vaccination
Phase 2
Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination
Time frame: 15th day after the full course of vaccination
Phase 2

11 secondary outcomes

Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Live SARS-CoV-2 neutralization assay) On the 30th day after the full course of vaccination, the neutralizing antibody level (wild Strains)
Time frame: 30th day after the full course of vaccination
Seroconversion and Geometric Mean Titer (GMT) of SARS-CoV-2-Specific Binding Antibody (IgG) Before each dose, the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after full course of vaccination
Time frame: before each dose , the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old group before each dose and on the 15th and 30th day after the full course of vaccination
Time frame: before each dose，the 15th, 30th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-COV-2 specific neutralizing antibody (live SARS-CoV-2 neutralization assay)) On the 30th day after the full course of vaccination
Time frame: 30th day after the full course of vaccination
Two-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Time frame: before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Two-dose group: Seroconversion before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Time frame: before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Two-dose group: Binding Antibody (IgG) before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Time frame: before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Time frame: before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group:Seroconversion before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Time frame: before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group:Binding Antibody (IgG) before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Time frame: before each dose，the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old 0,30,60 group before each dose , the 15th and 30th day after the full course of vaccination
Time frame: before each dose, 15th, 30th day after the full course of vaccination

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 28 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 and severity of any adverse reactions/events within 30 minutes after each dose of vaccination (time frame: through 30 minutes after each dose). The study lists 19 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 NCT04869592.

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 last refreshed its copy on 2 Nov 2026.