Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine

NCT05329038 | Unknown Phase 4

• 1 other identifier: PRO-nCOV-MA4009-SD
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ⅳ follow-up clinical trial based on the previous Phase Ⅳ clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2

  The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.

  14 days after the booster immunization of inactivated COVID-19 vaccine

Secondary Outcomes (10)

• Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2

  14 days after the booster immunization of inactivated COVID-19 vaccine

• GMT of neutralizing antibody against Prototype SARS-CoV-2

  14 days after the booster immunization of inactivated COVID-19 vaccine

• GMI of neutralizing antibody against Prototype SARS-CoV-2

  14 days after the booster immunization of inactivated COVID-19 vaccine

• Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains

  14 days after the booster immunization of inactivated COVID-19 vaccine

• Seropositive rate of neutralizing antibody against SARS-CoV-2 strains

  14 days after the booster immunization of inactivated COVID-19 vaccine

Study Arms (2)

Adult group

EXPERIMENTAL

90 subjects aged 18-59 years received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.

Biological: Inactivated COVID-19 Vaccine

Elderly group

EXPERIMENTAL

90 elderly aged 60 year and older received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.

Biological: Inactivated COVID-19 Vaccine

Interventions

Inactivated COVID-19 Vaccine BIOLOGICAL

600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

Also known as: CoronaVac

Adult group; Elderly group

Eligibility Criteria

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

You may qualify if:

• Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
• The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
• Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
• Proven legal identity;

You may not qualify if:

• 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;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
• Pregnancy or lactation;
• Receipt of attenuated live vaccines in the past 14 days;
• Receipt of inactivated or subunit vaccines in the past 7 days
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Rushan City Center for Disease Control and Prevention

Weihai, Shandong, 250014, 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

• Li Zhang, Master

  Shandong Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 14, 2022
• Study Start: April 19, 2022
• Primary Completion: June 19, 2022
• Study Completion: February 20, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

CN (1)