Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)

NCT ID: NCT04813562

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2022-07-30

Brief Summary

This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).

Detailed Description

This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 480 in total.

Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Middle-dose vaccine (18-59 years)

Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56

Group Type: EXPERIMENTAL

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

High-dose vaccine (18-59 years)

Two doses of High-dose vaccine at the schedule of day 0, 28, 56

Group Type: EXPERIMENTAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

Middle-dose vaccine (60-85 years)

Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56

Group Type: EXPERIMENTAL

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

High-dose vaccine (60-85 years)

Two doses of High-dose experimental vaccine at the schedule of day 0, 28, 56

Group Type: EXPERIMENTAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

Middle-dose placebo (18-59 years)

Three doses of middle-dose placebo at the schedule of day 0, 28, 56

Group Type: PLACEBO_COMPARATOR

a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

High-dose placebo (18-59 years)

Two doses of High-dose placebo at the schedule of day 0, 28, 56

Group Type: PLACEBO_COMPARATOR

a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Middle-dose placebo (60-85 years)

Three doses of middle-dose placebo at the schedule of day 0, 28, 56

Group Type: PLACEBO_COMPARATOR

a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

High-dose placebo (60-85 years)

Two doses of High-dose placebo at the schedule of day 0, 28, 56

Group Type: PLACEBO_COMPARATOR

a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56

Intervention Type: BIOLOGICAL

60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Interventions

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56

18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56

60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy subjects of ≥ 18 years old.
• The subject can understand and voluntarily sign the informed consent.
• Axillary temperature ≤37.0℃.
• General good health as established by medical history and physical examination

Exclusion Criteria

• 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 or history of Coronavirus Vaccination (including Emergency Vaccine and Experimental Vaccine).
• Positive in SARS-CoV-2 IgG or IgM antibody screening.
• Have a history of HIV infection;
• Women who are breastfeeding, pregnant, or planning to become pregnant during 6 months after full-course vaccination (based on the subject's self-report and blood pregnancy test results for women of childbearing age).
• 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(sbp≥160mmHg and/or dbp≥100mmHg) 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).
• 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.
• Have a long history of alcohol or drug abuse.
• Had urticaria one year before receiving the experimental vaccine;
• congenital or acquired angioedema/neuroedema;
• According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial, or Or influence the subject to sign the informed consent.

• Patients with severe allergic reactions after the previous dose of vaccination;
• Patients with serious adverse reactions causally related to the previous dose of vaccination.
• Other exclusion reasons suggested by the researchers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Academy of Military Medical Sciences，Academy of Military Sciences，PLA ZHONGYIANKE Biotech Co, Ltd. LIAONINGMAOKANGYUAN Biotech Co, Ltd

UNKNOWN

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengcai Zhu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Control and Prevention

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fanyue Meng, Doctor

Role: CONTACT

mfy19780712@163.com

18915999245

Facility Contacts

Mingwei Wei

Role: primary

wnmcwmw@163.com

15950529760

References

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.

Reference Type: DERIVED

PMID: 36103390 (View on PubMed)

Other Identifiers

JSVCT097

Identifier Type: -

Identifier Source: org_study_id