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

A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac） in Health Adults Aged 26-45 Years

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）

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.

• Study Type: Interventional
• Enrollment (Actual): 1080
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Jingliang Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）; 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection; Other Names: CoronaVac
Experimental: 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.	Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）; 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection; Other Names: CoronaVac
Experimental: 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.	Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）; 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection; Other Names: CoronaVac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population	GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population	Day 28 after the second dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population	Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population	Day 28 after the second dose
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population	Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population	Day 28 after the second dose
GMT of the neutralizing antibody to live SARS-CoV-2 in total population	GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population	Day 28 after the second dose
Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population	GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population	Day 28 after the second dose
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population	Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population	Day 28 after the second dose
Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population	Seropositive rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population	Day 28 after the second dose
GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population	GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population	Day 28 after the second dose
Seropositivity rate of anti-SARS-CoV-2 S antibody	Seropositivity rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose	Day 28 after the second dose
Seroconversion rate of anti-SARS-CoV-2 S antibody	Seroconversion rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose	Day 28 after the second dose
Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody	GMC of the anti-SARS-CoV-2 S antibody at day 28 after the second dose	Day 28 after the second dose
GMI of anti-SARS-CoV-2 S antibody	GMI of the anti-SARS-CoV-2 S antibody at day 28 after the second dose	Day 28 after the second dose
Incidence of adverse reactions after vaccination	Incidence of adverse reactions from the beginning of the vaccination to 28 days after the second dose	From the beginning of the vaccination to 28 days after the second dose

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.
• Investigators: Principal Investigator: Hongxing Pan, Master, Jiangsu Provincial Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-nCOV-4001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No