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
1 other identifier
interventional
1,080
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 covid19
Started May 2021
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 10, 2021
CompletedStudy Start
First participant enrolled
May 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedApril 13, 2022
May 1, 2021
Same day
May 10, 2021
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population
Day 28 after the second dose
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population
Day 28 after the second dose
GMT of the neutralizing antibody to live SARS-CoV-2 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
Day 28 after the second dose
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population
Day 28 after the second dose
- +7 more secondary outcomes
Study Arms (3)
Inactivated SARS-CoV-2 vaccine Lot 1
EXPERIMENTALParticipants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 1 according to 0,28-day immunization schedule.
Inactivated SARS-CoV-2 vaccine Lot 2
EXPERIMENTALParticipants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 2 according to 0,28-day immunization schedule.
Inactivated SARS-CoV-2 vaccine Lot 3
EXPERIMENTALParticipants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 3 according to 0,28-day immunization schedule.
Interventions
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Eligibility Criteria
You may qualify if:
- Healthy adults aged 26-45;
- The subjects can understand and voluntarily sign the informed consent form ;
- Proven legal identity.
You may not qualify if:
- 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；
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jingliang Wu
Huai'an, Jiangsu, 223300, China
Related Publications (1)
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.
PMID: 36441137DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongxing Pan, Master
Jiangsu Provincial Center for Disease Prevention and Control
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
May 10, 2021
First Posted
May 20, 2021
Study Start
May 11, 2021
Primary Completion
May 11, 2021
Study Completion
November 30, 2021
Last Updated
April 13, 2022
Record last verified: 2021-05