Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above
A Randomized, Double-blind, Active-controlled Clinical Trial, as Well as an Immuno-bridging Clinical Trial by Parallel Testing Previous Serum After Primary Immunization, to Evaluate the Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above
1 other identifier
interventional
1,750
1 country
1
Brief Summary
This is a randomized, double-blind, active-controlled Phase Ⅲ clinical trial, as well as an immuno-bridging clinical trial by parallel testing previous serum after primary immunization of COVID-19 vaccine (Vero cell), inactivated (Omicron variant). The main purpose of this study is to evaluate the superiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant), developed by Sinovac Research and Development Co., Ltd.in subjects who have received two- or three-dose Prototype COVID-19 vaccine （CZ strain）, compared with one-dose booster of Prototype COVID-19 vaccine （CZ strain） in subjects who have received three-dose Prototype COVID-19 vaccine （CZ strain）, and to evaluate the non-inferiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant), developed by Sinovac Research and Development Co., Ltd., in subjects who have received two- or three-dose Prototype COVID-19 vaccine, compared with the immunogenicity against SARS-CoV-2 Prototype strain induced by two-dose Prototype COVID-19 vaccine（CZ strain）after primary immunization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2023
CompletedMay 31, 2024
May 1, 2024
4 months
May 18, 2022
May 30, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1)
Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of COVID-19 vaccine (Omicron variant), 28 days (Day 28) after booster vaccination among subjects with two- or three-dose COVID-19 vaccine（CZ strain） ≥6 months before
28 days (Day 28) after booster vaccination
GMTs and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1)
GMTs and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of Prototype COVID-19 vaccine, 28 days (Day 28) after booster vaccination among subjects with three-dose Prototype COVID-19 vaccine≥6 months before
28 days (Day 28) after booster vaccination
GMTs of the neutralizing antibody to SARS-CoV-2 Prototype strain(CZ strain)
GMTs of the neutralizing antibody to SARS-CoV-2 Prototype strain induced by two doses of Prototype COVID-19 vaccine, 28 days after vaccination in previous clinical trial serums
28 days after vaccination of two doses of Prototype COVID-19 vaccine
Secondary Outcomes (9)
Geometric mean increases (GMIs) and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2)
28 days (Day 28) after booster vaccination
GMIs,seroconversion rates seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2)
28 days (Day 28) after booster vaccination
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain and Delta strain
28 days (Day 28) after booster vaccination
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain) and Delta strain
28 days (Day 28) after booster vaccination
GMTs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain), Delta strain and Omicron strain (BA.1, BA.2)
28 days after primary vaccination
- +4 more secondary outcomes
Other Outcomes (1)
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain (CZ strain) and Delta strain
7 days (Day 7) and 14 days (Day 14) after booster vaccination
Study Arms (9)
Experimental group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）
EXPERIMENTAL400 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）
ACTIVE COMPARATOR200 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Experimental group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）
EXPERIMENTAL100 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）
ACTIVE COMPARATOR50 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Experimental group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）
EXPERIMENTAL400 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）
ACTIVE COMPARATOR200 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Experimental group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）
EXPERIMENTAL100 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）
ACTIVE COMPARATOR50 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Historical control group
ACTIVE COMPARATORBackup serum samples will be selected from 250 healthy adult subjects aged 26-45 years who received two doses of inactivated COVID-19 vaccine(CZ strain)from clinical trial of lot-to-lot consistency of an inactivated SARS-CoV-2 Vaccine(Pro-NCOV-4001) to detect neutralizing antibodies against the CZ, Delta and Omicron strains.
Interventions
The COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)was manufactured by Sinovac Research\& Development Co., Ltd.1200SOU inactivated SARS-CoV-2 Omicron strain in 0.5ml of aluminium hydroxide solution per injection.
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18 years and above;
- Subjects completed two doses of the prototype COVID-19 vaccine (CZ strain)(the interval between the first dose and the second dose was 1-2 months)or completed 3 doses of prototype COVID-19 vaccine (CZ strain)over 6 months (the interval between the first dose and the second dose was 1-2 months, and the interval between the second dose and the third dose was 6 months or more);
- The subjects can understand and voluntarily sign the informed consent form;
- Provide legal identification and vaccination certificate of prototype COVID-19 vaccine (CZ strain).
You may not qualify if:
- History of SARS-CoV-2 infection(laboratory confirmed);
- Close contact with a confirmed COVID-19 (nucleic acid test or antigen test positive patients)within 14 days prior to randomization;
- Received other COVID-19 vaccine in the past except for two or three doses of prototype vaccine;
- Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
- Autoimmune disease and/or blood disease history (including but not limited to systemic lupus erythematosus, thyroidectomy, autoimmune thyroid disease, any form of malignancy, absence of spleen, functional absence of spleen, or splenectomy for any condition),patients with well-controlled type 1 diabetes can be enrolled;
- Serious chronic diseases, such as serious cardiovascular diseases, hypertension, diabetes, liver and 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;
- Long-term history of alcohol or drug abuse;
- Received blood products within 3 months prior to receiving the investigational vaccine, or planning to receive the above treatments during the study period;
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huaiyin Center for Disease Control and Prevention
Huai'an, Jiangsu, 223300, China
Related Publications (1)
Hu J, Liu Y, Liu S, Shu Q, Yang X, Chu K, Qiao Y, Hu Y, Wang K, Pan H. Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial. Front Immunol. 2023 Sep 18;14:1241153. doi: 10.3389/fimmu.2023.1241153. eCollection 2023.
PMID: 37799724BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongxing Pan, Master
Jiangsu Provincial Center for Disease Prevention and Control
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2022
First Posted
May 19, 2022
Study Start
June 1, 2022
Primary Completion
September 26, 2022
Study Completion
March 9, 2023
Last Updated
May 31, 2024
Record last verified: 2024-05