Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults

Phase 3

Completed

• Conditions: Covid19
• Interventions: Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14; Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly; Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14

• Registration Number: NCT04617483
• Lead Sponsor: Sinovac Research and Development Co., Ltd.

Brief Summary

This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.

Detailed Description

This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. Totally 1040 subjects，including: 130 subjects aged 18\~25 years; 520 subjects aged 26\~45 years, with 260 in each group; 130 subjects aged 46\~59 years; 260 subjects aged ≥60 years.

Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.

Study Timeline

• Study Start: 2020-10-31
• Status Verified: 2020-11
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Primary Completion: 2020-11-28
• Study Completion: 2021-05-31
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1040

Inclusion Criteria

1. Healthy adults aged 18-59 or elderly aged ≥60 years;
2. Proven legal identity.

Exclusion Criteria

1. Travel/residence history of communities with reported cases within 14 days before trial;
2. History of exposure to Novel Coronavirus infection (nucleic acid positive) within 14 days prior to the trial;
3. Exposed to patients with fever or respiratory symptoms from communities with reported cases within 14 days prior to the trial;
4. Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial;
5. History of SARS-CoV-2 infection;
6. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
7. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
8. Autoimmune disease or immunodeficiency/immunosuppression;
9. Patients with serious chronic diseases, serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.;
10. Serious neurological disorder (epilepsy, convulsions or convulsions) or psychosis;
11. History of thyroid disease or thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy caused by any circumstance;
12. Coagulation dysfunction (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by doctors;
13. Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;
14. Long history of alcohol or drug abuse;
15. Received blood products within 3 months prior to receiving the vaccine;
16. Received other research drugs within 30 days prior to receiving the vaccine;
17. Received live attenuated vaccine within 14 days prior to receiving the vaccine;
18. Received subunit or inactivated vaccine within 7 days prior to receiving the vaccine;
19. Onset of various acute or chronic diseases within 7 days prior to the study;
20. Axillary temperature of >37.0℃ before inoculation of the vaccine;
21. Those who are already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to become pregnant within 2 months;
22. In the opinion of the investigator, the participants had any other factors that made them unsuitable to participate in the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aged 26-45, Commercial Scale	Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14	Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years.
Aged ≥60, Pilot Scale	Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly	Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years.
Aged 18-59, Pilot Scale	Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14	Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years.

Primary Outcome Measures

Name	Time	Method
Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody	Day 14 after the full course vaccination	Neutralizing antibody assay will be performed using the micro-neutralization method

Secondary Outcome Measures

Name	Time	Method
Safety index-Incidence of adverse reactions	From the beginning of the vaccination to 28 days after the full course vaccination	Incidence of adverse reactions from the beginning of the vaccination to 28 days after the full course vaccination
Safety index-Incidence of serious adverse events	From the beginning of the vaccination to 6 months after the full course vaccination	SAE will be collected throughout the clinical trial
Immunogenicity index-Seroconversion rate of the neutralizing antibody	Day 14 after the full course vaccination	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
Immunogenicity index-Seropositive rate of the neutralizing antibody	Day 14 after the full course vaccination	Neutralizing antibody assay will be performed using the micro-neutralization method. Subjects with a antibody titer ≥1:8 will defined as seropositive

Trial Locations

Locations (1)

Dafeng District Center for Disease Prevention and Control; 🇨🇳 Yancheng, Jiangsu, China