COVID-19Phase 1NCT04636333

Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)

A Phase 1 study testing Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 and Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. 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
What is being tested?: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 and Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 216 participants
Where: 1 siteChina
Study dates: 30 Oct 2020to 7 Jul 2022
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

Healthy subjects of ≥ 18 years old.
The subject can understand and voluntarily sign the informed consent.
The subject can The subject canprovide legal identification.

Who cannot join

Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
Have a history of SARS.
Have a history of SARS-CoV-2 infection.

Show all 44Show fewer

Positive in SARS-CoV-2 IgG or IgM antibody screening.
Positive in RT-PCR test of SARS-CoV-2 in throat swab.
Positive in HIVantibody screening.
Women who are breastfeeding, pregnant, or planning to become pregnant during the study period (based on the subject's self-report and blood pregnancy test results for women of childbearing age), or men who plan to conceive their partners during the study period.
Subjects with body mass index (BMI) ≥35 kg/m2.
Have a history of asthma, a history of vaccine or vaccine component allergy, have serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
Subjects with severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.
Subjects with severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
Subjects with thyroid disease or history of thyroidectomy, no spleen, functional asthenia, and any spleen or splenectomy caused by any condition.
Abnormal blood coagulation function diagnosed by a doctor (such as coagulation factor deficiency, coagulopathy, abnormal platelet) or obvious bruise or coagulation disorder.
Have received immunosuppressant therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis).
Physical examination or chest CT imaging reveals clinically significant abnormalities.
Abnormal laboratory test results such as hematology and biochemistry that are beyond the reference value range and have clinical significance.
Routine blood test: white blood cell count, hemoglobin, platelet count.
Blood biochemical index detection: alanine aminotransferase (ALT), aspartate aminotransferase (AST), fasting blood glucose, C-reactive protein, total bilirubin (TBIL), creatinine (CR), creatine phosphokinase (CPK).
Urine routine indicators: urine protein (PRO), urine sugar, urine red blood cells.
Coagulation function test: prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).
Have a long history of alcohol or drug abuse.
Received blood products within 3 months before receiving trial vaccine.
Received other study drugs within 30 days before receiving the trail vaccine.
Received a live attenuated vaccine within 14 days before receiving the experimental vaccine.
Received a subunit or inactivated vaccine within 7 days before receiving the experimental vaccine.
Various acute or chronic diseases occurred in the past 7 days.
Axillary body temperature>37.0℃ before vaccination.
According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
If one of the following (1) to (4) adverse events (AE) occurs, the vaccination is prohibited, but other research steps can be continued according to the investigator's judgment; if one of the following (5), (6) adverse events occurs , The investigator will judge whether to inoculate; if one of the following events (7) to (10) occurs, the vaccination can be postponed within the time window specified in the plan.
(1)The subjects used the same vaccine other than the experimental vaccine during the study.
(2)Any serious adverse reactions that are causally related to vaccination.
(3)Severe allergic or hypersensitivity reactions after vaccination (including urticaria/skin rash within 30 minutes after vaccination).
(4)Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection.
(5)Acute or new-onset chronic disease after vaccination.
(6)Other reactions (including severe pain, severe swelling, severe activity limitation, persistent high fever, severe headache, or other systemic or local reactions) are judged by the investigator.
(7)Acute illness at the time of vaccination (Acute illness refers to moderate or severe illness with or without fever).
(8)Axillary temperature >37.0℃ before vaccination.
(9)Vaccination of subunit vaccine or inactivated vaccine within 7 days, live attenuated vaccine within 14 days.
(10)According to the investigator's judgment, the subject has any other factors that are not suitable for vaccination.

Trial locations and contacts

1 site in 1 country.

Fanyue Meng, Doctor contact

18915999245

mfy19780712@163.com

China1 site, 1 recruiting

Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu
Mingwei Wei, 15950529760, wnmcwmw@163.com
Recruiting

Other trials in China

About this study

Official title: Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study

Read the detailed description

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. Healthy adults who are ≥18 years old and ≤59 years old will be enrolled in the adult group and healthy elderly population who are >59 years old will be enrolled in the elderly group. To ensure the enrollment of healthy subjects, screening tests (hematology, biochemistry, and urinalysis) will be performed prior to the vaccination. In the adults group, there are four regimen cohort: middle-dose at 0, 14 schedule, high-dose at 0, 14 schedule, middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. In the elderly group, there are two regimen cohort: middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1.

The study will set up an Independent Data Monitoring Committee (IDMC) to conduct overall supervision. The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended.

Conditions: COVID-19
Being tested: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28, Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28, Two doses of placebo at the schedule of day 0, 14 #middle-dose group#
Keywords: Safety, Tolerability, Immunogenicity, SARS-CoV-2 Vaccine, Recombinant vaccine
Medical subject headings: COVID-19

What participants receive

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

Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14Biological
Two doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14.
Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Biological
Three doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14Biological
Two doses of high-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHOCell) at the schedule of day 0, 14.
Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Biological
Three doses of middle-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
Two doses of placebo at the schedule of day 0, 14 #middle-dose group#Biological
Two doses of placebo (0.5ml) at the schedule of day 0, 14.
Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#Biological
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.
Two doses of placebo at the schedule of day 0, 14 #High-dose group#Biological
Two doses of placebo (0.5ml) at the schedule of day 0, 14.
Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#Biological
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.

Study groups in NCT04636333
Study group	Role	What they receive
Middle-dose vaccine (18-59 years) & Two dose regimen	Experimental	Two doses of middle-dose experimental vaccine at the schedule of day 0, 14. Receives: Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
Middle-dose vaccine (18-59 years) & Three dose regimen	Experimental	Three doses of middle-dose experimental vaccine at the schedule of day 0, 14 28. Receives: Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
High-dose vaccine (18-59 years) & Two dose regimen	Experimental	Two doses of high-dose experimental vaccine at the schedule of day 0, 14. Receives: Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
High-dose vaccine (18-59 years) & Three dose regimen	Experimental	Two doses of High-dose vaccine at the schedule of day 0, 14, 28. Receives: Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
Middle-dose vaccine (> 59 years) & Three dose regimen	Experimental	Three doses of middle-dose experimental vaccine at the schedule of day 0, 14, 28. Receives: Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
High-dose vaccine (> 59 years) & Three dose regimen	Experimental	Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28. Receives: Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28
Middle-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	Two doses of middle-dose placebo at the schedule of day 0, 14. Receives: Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group#
Middle-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	Three doses of middle-dose placebo at the schedule of day 0, 14, 28. Receives: Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#
High-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	Two doses of high-dose placebo at the schedule of day 0, 14. Receives: Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group#
High-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	Three doses of high-dose placebo at the schedule of day 0, 14, 28. Receives: Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#
Middle-dose placebo (> 59 years) & Three dose regimen	Placebo comparator	Three doses of high-dose placebo at the schedule of day 0, 14, 28. Receives: Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#
High-dose placebo (> 59 years) & Three dose regimen	Placebo comparator	Three doses of high-dose placebo at the schedule of day 0, 14, 28. Receives: Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#

What is being measured

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

The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
Measured: 28 days after first dose

Secondary outcomes (7)

The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
Measured: 7 days after each dose
The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo
Measured: 3 days after each dose
The proportion of serious adverse events up to Month 12 after prime and boost vaccination.
Measured: Month 12 after prime and boost vaccination
The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Measured: Day 14, Day 21, Day 28, Day 42 after prime vaccination
The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Measured: Day 14, Day 21, Day 28, Day 42 after prime vaccination
The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GM at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#
Measured: Day 28, Day 35, Day 42, Day 56 after prime vaccination
The proportion of IgG antibody positive rate at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#
Measured: Day 28, Day 35, Day 42, Day 56 after prime vaccination

Timeline

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

30 Oct 20207 Jul 2022

First posted19 Nov 2020
Study start30 Oct 2020
Primary completion7 Dec 2021
Study completion7 Jul 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 216 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04636333
Sponsor's protocol ID: JSVCT096
Status last verified: Mar 2022
First submitted: 17 Nov 2020
Last updated: 31 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016.
PubMed 36103390

Want to know more?

Fanyue Meng, Doctor

18915999245

mfy19780712@163.com

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study
ClinicalTrials.gov ID: NCT04636333
Acronym / sponsor ID: JSVCT096
Conditions: COVID-19
Keywords: Safety, Tolerability, Immunogenicity, SARS-CoV-2 Vaccine, Recombinant vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 216 participants (estimated)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Collaborators: 307 Hospital of PLA, ZHONGYIANKE Biotech Co, Ltd., LIAONINGMAOKANGYUAN Biotech Co, Ltd
Study start: 30 Oct 2020 (actual)
Primary completion: 7 Dec 2021 (actual)
Study completion: 7 Jul 2022 (estimated)
First posted: 19 Nov 2020 (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.

Detailed description

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. Healthy adults who are ≥18 years old and ≤59 years old will be enrolled in the adult group and healthy elderly population who are >59 years old will be enrolled in the elderly group. To ensure the enrollment of healthy subjects, screening tests (hematology, biochemistry, and urinalysis) will be performed prior to the vaccination. In the adults group, there are four regimen cohort: middle-dose at 0, 14 schedule, high-dose at 0, 14 schedule, middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. In the elderly group, there are two regimen cohort: middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 12

Arm	Type	Receives
Middle-dose vaccine (18-59 years) & Two dose regimen	Experimental	Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14Two doses of middle-dose experimental vaccine at the schedule of day 0, 14.
Middle-dose vaccine (18-59 years) & Three dose regimen	Experimental	Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Three doses of middle-dose experimental vaccine at the schedule of day 0, 14 28.
High-dose vaccine (18-59 years) & Two dose regimen	Experimental	Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14Two doses of high-dose experimental vaccine at the schedule of day 0, 14.
High-dose vaccine (18-59 years) & Three dose regimen	Experimental	Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Two doses of High-dose vaccine at the schedule of day 0, 14, 28.
Middle-dose vaccine (> 59 years) & Three dose regimen	Experimental	Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Three doses of middle-dose experimental vaccine at the schedule of day 0, 14, 28.
High-dose vaccine (> 59 years) & Three dose regimen	Experimental	Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
Middle-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group#Two doses of middle-dose placebo at the schedule of day 0, 14.
Middle-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#Three doses of middle-dose placebo at the schedule of day 0, 14, 28.
High-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group#Two doses of high-dose placebo at the schedule of day 0, 14.
High-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#Three doses of high-dose placebo at the schedule of day 0, 14, 28.
Middle-dose placebo (> 59 years) & Three dose regimen	Placebo comparator	Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#Three doses of high-dose placebo at the schedule of day 0, 14, 28.
High-dose placebo (> 59 years) & Three dose regimen	Placebo comparator	Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#Three doses of high-dose placebo at the schedule of day 0, 14, 28.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy subjects of ≥ 18 years old.
The subject can understand and voluntarily sign the informed consent.
The subject can The subject canprovide legal identification.

Key exclusion criteria (44 listed)

Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
Have a history of SARS.

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
Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14Two doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14.	Biological	Middle-dose vaccine (18-59 years) & Two dose regimen
Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Three doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.	Biological	Middle-dose vaccine (18-59 years) & Three dose regimen, Middle-dose vaccine (> 59 years) & Three dose regimen
Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14Two doses of high-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHOCell) at the schedule of day 0, 14.	Biological	High-dose vaccine (18-59 years) & Two dose regimen
Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28Three doses of middle-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.	Biological	High-dose vaccine (18-59 years) & Three dose regimen, High-dose vaccine (> 59 years) & Three dose regimen
Two doses of placebo at the schedule of day 0, 14 #middle-dose group#Two doses of placebo (0.5ml) at the schedule of day 0, 14.	Biological	Middle-dose placebo (18-59 years) & Two dose regimen
Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.	Biological	Middle-dose placebo (18-59 years) & Three dose regimen, Middle-dose placebo (> 59 years) & Three dose regimen
Two doses of placebo at the schedule of day 0, 14 #High-dose group#Two doses of placebo (0.5ml) at the schedule of day 0, 14.	Biological	High-dose placebo (18-59 years) & Two dose regimen
Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.	Biological	High-dose placebo (18-59 years) & Three dose regimen, High-dose placebo (> 59 years) & Three dose regimen

Primary outcome

The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
Time frame: 28 days after first dose

7 secondary outcomes

The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
Time frame: 7 days after each dose
The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo
Time frame: 3 days after each dose
The proportion of serious adverse events up to Month 12 after prime and boost vaccination.
Time frame: Month 12 after prime and boost vaccination
The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Time frame: Day 14, Day 21, Day 28, Day 42 after prime vaccination
The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Time frame: Day 14, Day 21, Day 28, Day 42 after prime vaccination
The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GM at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#
Time frame: Day 28, Day 35, Day 42, Day 56 after prime vaccination
The proportion of IgG antibody positive rate at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#
Time frame: Day 28, Day 35, Day 42, Day 56 after prime vaccination

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Derived from this study: PubMed 36103390Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016.

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COVID -19

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.

Fanyue Meng, Doctor contact

18915999245

mfy19780712@163.com

Fengcai Zhu, Doctor principal investigator

Jiangsu Province Centers for Disease Control and Prevention

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 3 inclusion and 44 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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?

Results are not available in the source record.

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

Contact Fanyue Meng, Doctor (18915999245, mfy19780712@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo. (time frame: 28 days after first dose). 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 NCT04636333, which also lists 1 linked publication.

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 31 Mar 2022.