Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19

NCT05079217 | Unknown Phase 4

• 1 other identifier: PRO-nCOV-4007
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）

  GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.

  Day 28 after booster vaccination

Secondary Outcomes (11)

• Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain）

  Day 28 after booster vaccination

• Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain）

  Day 28 after booster vaccination

• Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain）

  Day 28 after booster vaccination

• Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain）

  Day 28 after booster vaccination

• Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain）

  Day 28 after booster vaccination

Other Outcomes (2)

• Immunogenicity index-the seropositive rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）

  6 months after the booster vaccination

• Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）

  6 months after the booster vaccination

Study Arms (2)

Experimental Group

EXPERIMENTAL

600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .

Biological: High-dosage SARS-CoV-2 vaccine

Control Group

ACTIVE COMPARATOR

600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .

Biological: Medium-dosage SARS-CoV-2 vaccine

Interventions

High-dosage SARS-CoV-2 vaccine BIOLOGICAL

SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Also known as: CoronaVac

Experimental Group

Medium-dosage SARS-CoV-2 vaccine BIOLOGICAL

SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Also known as: CoronaVac

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-59;
• Proven legal identity;
• The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
• Have received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd at an interval of 21 to 35 days and is currently 6-8 months (180 to 240 days) after the second dose.

You may not qualify if:

• History of SARS-CoV-2 infection(laboratory confirmed);
• Have received three and more doses of inactivated SARS-CoV-2 vaccine;
• Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
• Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
• 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;
• 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;
• Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
• Axillary temperature \>37.0°C;
• Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Xinqi City Center for Disease Control and Prevention

Xinqi, Jiangsu, 221400, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hongxing Pan, Master

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 15, 2021
• Study Start: December 17, 2021
• Primary Completion: December 21, 2021
• Study Completion: June 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2021-10

Locations

CN (1)