Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19

COVID-19 Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged 3-17 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551547
• Other study ID #: PRO-nCOV-1003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 31, 2020
• Est. completion date: February 8, 2023

Study information

• Verified date: June 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years

Description:

This study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2 clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 552 subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: February 8, 2023
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• Healthy children and adolescents aged 3-17 years;
• The subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8-17 years old);
• Proven legal identity.

Exclusion Criteria:

• Travel history / residence history of communities with case reports within 14 days;
• History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
• Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
• 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;
• History of SARS-CoV-2 infection;
• 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 or immunodeficiency / immunosuppression;
• 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;
• Physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to

phase I clinical trials):

1. Blood routine test: white blood cell count, hemoglobin, platelet count;

2. Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;

3. Urine routine index: urine protein (PRO);

• 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;
• Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
• Axillary temperature >37.0°C;
• Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 300SU/0.5ml
• Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml

Other:
• Two doses of placebo at the schedule of day 0,28
The placebo contains no active ingredient and manufactured by Sinovac Research & Development Co., Ltd.

Locations

Country	Name	City	State
China	Zanhuang county Center for Disease Control and Prevention	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Phase ?: The seropositive rate of neutralizing antibody	The seropositive rate of neutralizing antibody against live SARS-CoV-2 6 months and 12 months after the second dose vaccination	6 months and 12 months after the second dose vaccination
Other	Phase ?:The GMT of neutralizing antibody	The GMT of neutralizing antibody against live SARS-CoV-2 6 months and 12 months after the second dose vaccination.	6 months and 12 months after the second dose vaccination.
Other	Phase ?: The seropositive rate of neutralizing antibody	The seropositive rate of neutralizing antibody against live SARS-CoV-2 3 months, 6 months, 9 months and 12 months after the second dose vaccination	3 months, 6 months, 9 months and 12 months after the second dose vaccination
Other	Phase ?: The GMT of neutralizing antibody	The GMT of neutralizing antibody against live SARS-CoV-2 3 months, 6 months, 9 months and 12 months after the second dose vaccination.	3 months, 6 months, 9 months and 12 months after the second dose vaccination.
Other	Phase ?: The seropositive rate	The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 28 days after the booster dose	28 days after the booster dose
Other	Phase ?: The GMT	The GMT of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 28 days after the booster dose	28 days after the booster dose
Other	Phase ?: The GMI	The GMI of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 28 days after the booster dose	28 days after the booster dose
Other	Phase ?: the seropositive rate	The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 6 months and 12 months after the booster dose.	6 months and 12 months after the booster dose
Other	Phase ?: the GMT	The GMT of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 6 months and 12 months after the booster dose.	6 months and 12 months after the booster dose
Primary	Safety index-incidence of adverse reactions	Incidence of adverse reactions after each dose vaccination.	Day 0-28 after each dose vaccination
Primary	Immunogenicity index-seroconversion rates of neutralizing antibody	Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (=1:8), or =4 fold increase from baseline.	The 28th day after the second dose vaccination
Secondary	Safety index-incidence of serious adverse events	SAE will be collected throughout the clinical trial.	From the beginning of the vaccination to 12 months after the second dose vaccination
Secondary	Immunogenicity index-seropositive rates of neutralizing antibody	Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer =1:8 will defined as seropositive.	The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Secondary	Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody	Neutralizing antibody assay will be performed using the micro-neutralization method.	The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Secondary	Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody	Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.	The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Secondary	Safety index-Incidence rate of adverse reactions	Incidence rate of adverse reactions within 7 days after each dose vaccination	Within 7 days after each dose vaccination
Secondary	Safety index-Incidence of abnormal laboratory index	Incidence of abnormal laboratory index (blood routine test, blood chemistry test, and urine routine test) on the 3th day after each dose of vaccination in phase ?	On the 3th day after each dose of vaccination in phase ?
Secondary	Safety index-Incidence rate of AESIs	Incidence rate of SAEs and AESIs from the beginning of the vaccination to 12 months after the last dose vaccination	From the beginning of the vaccination to 12 months after the last dose vaccination
Secondary	Immunogenicity index- GMI of neutralizing antibody	GMI of neutralizing antibodies 28 days after the second dose vaccination	28 days after the second dose vaccination
Secondary	Immunogenicity index-the seroconversion rate	The seroconversion rate 28 days after the first dose vaccination in phase ?	28 days after the first dose vaccination in phase ?
Secondary	Immunogenicity index-the seropositive rate	Seropositive rate 28 days after the first dose vaccination in phase ?	28 days after the first dose vaccination in phase ?
Secondary	Immunogenicity index-the GMT	The GMT 28 days after the first dose vaccination in phase ?	28 days after the first dose vaccination in phase ?
Secondary	Immunogenicity index-the GMI	The GMI 28 days after the first dose vaccination in phase ?	28 days after the first dose vaccination in phase ?