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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617483
• Other study ID #: PRO-nCOV-3001
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2020
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: May 31, 2021
• Est. primary completion date: November 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.
• Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.
• Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly
The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.

Locations

Country	Name	City	State
China	Dafeng District Center for Disease Prevention and Control	Yancheng	Jiangsu

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