Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

NCT ID: NCT04894227

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1080 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2021-11-30

Brief Summary

This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac）manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of CoronaVac in healthy adults aged 26-45 years.

Detailed Description

This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. A total of 1080 healthy subjects aged 26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.

Conditions

COVID-19

Study Design

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

Study Groups

Inactivated SARS-CoV-2 vaccine Lot 1

Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 1 according to 0,28-day immunization schedule.

Group Type: EXPERIMENTAL

Inactivated SARS-CoV-2 Vaccine (Vero cell）

Intervention Type: BIOLOGICAL

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Inactivated SARS-CoV-2 vaccine Lot 2

Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 2 according to 0,28-day immunization schedule.

Group Type: EXPERIMENTAL

Inactivated SARS-CoV-2 Vaccine (Vero cell）

Intervention Type: BIOLOGICAL

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Inactivated SARS-CoV-2 vaccine Lot 3

Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 3 according to 0,28-day immunization schedule.

Group Type: EXPERIMENTAL

Inactivated SARS-CoV-2 Vaccine (Vero cell）

Intervention Type: BIOLOGICAL

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Interventions

Inactivated SARS-CoV-2 Vaccine (Vero cell）

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Intervention Type: BIOLOGICAL

Other Intervention Names

CoronaVac

Eligibility Criteria

Inclusion Criteria

• Healthy adults aged 26-45;
• The subjects can understand and voluntarily sign the informed consent form ;
• Proven legal identity.

Exclusion Criteria

• Travel history / residence history of communities with case reports within 14 days prior to the study;
• History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days prior to the study;
• Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days prior to the study;
• Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days prior to the study;
• History of SARS-CoV-2 infection or receiving COVID-19 vaccine;
• History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
• Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)
• Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
• History of alcohol or drug abuse;
• Receipt of blood products within in the past 3 months；
• Receipt of other investigational drugs in the past 30 days；
• Receipt of attenuated live vaccines in the past 14 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;
• Onset of various acute or chronic diseases within 7 days prior to the study;
• Axillary temperature >37.0°C;
• Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months;
• The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Research and Development Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxing Pan, Master

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Prevention and Control

Locations

Jingliang Wu

Huai'an, Jiangsu, China

Countries

China

References

Zhu D, Hu Y, Jiang Z, Yang T, Chu K, Zhang H, Hu J, Meng X, Tan Z, Wu J, Lian X, Li C, Pan H. Lot-to-lot consistency, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults: A randomized, double-blind, phase IV trial. Hum Vaccin Immunother. 2022 Nov 30;18(6):2135929. doi: 10.1080/21645515.2022.2135929. Epub 2022 Nov 28.

Reference Type: DERIVED

PMID: 36441137 (View on PubMed)

Other Identifiers

PRO-nCOV-4001

Identifier Type: -

Identifier Source: org_study_id