Back to resultsSafety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Two doses of placebo at the schedule of day 0,28
Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged ≥60 years;
- Be able to understand and sign the informed consent voluntarily;
- Provide legal identification;
Exclusion Criteria:
- Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
- Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
- Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
- Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
- History of SARS;
- History of SARS-CoV-2 infection;
- History of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
- Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
- Serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis;
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- Long history of alcohol or drug abuse;
- Receipt of blood products 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;
- According to the investigator's judgment, the subject has any other factors that are not suitable for the clinical trial.
Sites / Locations
- Renqiu City Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
Experimental Vaccine-medium dosage
Experimental Vaccine-high dosage
Placebo
Experimental Vaccine-low dosage
Arm Description
24 participants in medium-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in medium-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose ) and the second booster dose (the fourth dose) 1 year after the second dose.
24 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose .
24 participants including 12 at medium dosage stage and 12 at high dosage in phase Ⅰ will receive two doses of placebo according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 50 participants in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
100 participants at low dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
Outcomes
Primary Outcome Measures
Safety index-incidence of adverse reactions
Incidence of adverse reactions after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination.
Secondary Outcome Measures
Safety index-incidence rate of adverse reactions
Incidence rate of adverse reactions within 7 days after each dose vaccination
Safety index-incidence rate of serious adverse events in phase Ⅰ
Incidence rate of SAEs from the beginning of the vaccination to 6 months after the booster immunization in phase Ⅰ
Safety index-incidence rate of serious adverse events in phase Ⅱ
Incidence rate of SAEs from the beginning of the vaccination to 12 months after the booster immunization vaccination in phase Ⅱ
Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies
The seropositive rate, GMT, and GMI of neutralizing antibodies 28 days after the second dose vaccination;
Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ
The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the first dose vaccination in phase Ⅰ
Full Information
NCT ID
NCT04383574
First Posted
May 9, 2020
Last Updated
August 9, 2022
Sponsor
Sinovac Life Sciences Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04383574
Brief Title
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)
Official Title
A Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cell), in Healthy Elderly Aged 60 Years and Above
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy elderly aged 60 years and above.
Detailed Description
This study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2 clinical trial in healthy elderly aged 60 years and above. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 422 subjects will be enrolled, with 72 in phase 1 and 350 in phase 2. 72 Subjects with 36 in medium-dosage group and 36 in high-dosage group in phase 1 will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and the subjects at each dosage group will be assigned in a 2:1 ratio to receive investigational vaccine or placebo respectively.All enrolled subjects will receive 1 dose of booster immunization 1 year after primary immunization.350 Subjects in phase 2 will receive two doses of primary immunization according to the immunization schedule of day 0,28,the subjects will be assigned in a ratio of 2:2:2:1 to receive the low dosage, medium dosage, high dosage vaccine, or placebo. All enrolled subjects will received 1 dose of booster immunization(the third dose ) 6 months after primary immunization.And subjects in medium-dosage group and high -dosage group will receive the second booster dose (the fourth dose) 1 year after the second dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
422 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Vaccine-medium dosage
Arm Type
Experimental
Arm Description
24 participants in medium-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in medium-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose ) and the second booster dose (the fourth dose) 1 year after the second dose.
Arm Title
Experimental Vaccine-high dosage
Arm Type
Experimental
Arm Description
24 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose .
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
24 participants including 12 at medium dosage stage and 12 at high dosage in phase Ⅰ will receive two doses of placebo according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 50 participants in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
Arm Title
Experimental Vaccine-low dosage
Arm Type
Experimental
Arm Description
100 participants at low dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
Intervention Type
Biological
Intervention Name(s)
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Intervention Description
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd..Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (600SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.
Intervention Type
Biological
Intervention Name(s)
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Intervention Description
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.
Intervention Type
Biological
Intervention Name(s)
Two doses of placebo at the schedule of day 0,28
Intervention Description
The placebo was manufactured by Sinovac Research & Development Co., Ltd., Two doses of placebo at the schedule of day 0,28,and one dose of booster immunization with placebo 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
Intervention Type
Biological
Intervention Name(s)
Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Intervention Description
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd..Two doses of low dosage (300SU/0.5ml)experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with low dosage (300SU/0.5ml) experimental vaccine 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
Primary Outcome Measure Information:
Title
Safety index-incidence of adverse reactions
Description
Incidence of adverse reactions after each dose vaccination
Time Frame
Day 0-28 after each dose vaccination
Title
Immunogenicity index-seroconversion rates of neutralizing antibody
Description
The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination.
Time Frame
28 days after the second dose vaccination
Secondary Outcome Measure Information:
Title
Safety index-incidence rate of adverse reactions
Description
Incidence rate of adverse reactions within 7 days after each dose vaccination
Time Frame
within 7 days after each dose vaccination
Title
Safety index-incidence rate of serious adverse events in phase Ⅰ
Description
Incidence rate of SAEs from the beginning of the vaccination to 6 months after the booster immunization in phase Ⅰ
Time Frame
From the beginning of the vaccination to 6 months after the booster immunization
Title
Safety index-incidence rate of serious adverse events in phase Ⅱ
Description
Incidence rate of SAEs from the beginning of the vaccination to 12 months after the booster immunization vaccination in phase Ⅱ
Time Frame
From the beginning of the vaccination to 12 months after the booster immunization vaccination
Title
Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies
Description
The seropositive rate, GMT, and GMI of neutralizing antibodies 28 days after the second dose vaccination;
Time Frame
28 days after the second dose vaccination
Title
Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ
Description
The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the first dose vaccination in phase Ⅰ
Time Frame
28 days after the first dose vaccination in phase Ⅰ
Other Pre-specified Outcome Measures:
Title
Immunogenicity index -seropositive rate and GMT of neutralizing antibodies
Description
The seropositive rate and GMT 6 months after the second dose vaccination
Time Frame
6 months after the second dose vaccination
Title
Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅰ
Description
The seropositive rate and GMT 12 months after the second dose vaccination in phase Ⅰ
Time Frame
12 months after the second dose vaccination
Title
Immunogenicity index -seropositive rate, GMT, and GMI of neutralizing antibodies
Description
The seropositive rate, GMT, and GMI 28 days after the booster vaccination in phase Ⅰ
Time Frame
28 days after the booster vaccination
Title
Immunogenicity index -seropositive rate, GMT of neutralizing antibodies in phase Ⅱ
Description
The seropositive rate, GMT, and GMI 7 days (or 14 days) and 28 days after the booster vaccination in phase Ⅱ
Time Frame
7 days (or 14 days) and 28 days after the booster vaccination
Title
Immunogenicity index -seropositive rate and GMT of neutralizing antibodies
Description
The seropositive rate and GMT 6 months after the booster vaccination
Time Frame
6 months after the booster vaccination
Title
Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅱ
Description
The seropositive rate and GMT 12 months after the booster vaccination in phase Ⅱ
Time Frame
12 months after the booster vaccination
Title
Immunogenicity index-seropositive rate,GMT and GMI of neutralizing antibodies
Description
The seropositive rate, GMT and GMI of neutralizing antibody against CZ, Delta and Omicron antigens 14 days after the fourth dose.
Time Frame
14 days after the fourth dose
Title
Immunogenicity index-Seropositive rate and GMTof neutralizing antibodies
Description
The seropositive rate and GMT of neutralizing antibody against Delta and Omicron antigens 6 months after the fourth dose.
Time Frame
6 months after the fourth dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged ≥60 years;
Be able to understand and sign the informed consent voluntarily;
Provide legal identification;
Exclusion Criteria:
Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
History of SARS;
History of SARS-CoV-2 infection;
History of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
Autoimmune disease or immunodeficiency / immunosuppression;
Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
Serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis;
Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
Long history of alcohol or drug abuse;
Receipt of blood products 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;
According to the investigator's judgment, the subject has any other factors that are not suitable for the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuliang Zhao, Master
Organizational Affiliation
Hubei Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renqiu City Center for Disease Control and Prevention
City
Renqiu
State/Province
Hebei
ZIP/Postal Code
062550
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35660738
Citation
Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w.
Results Reference
derived
PubMed Identifier
34890537
Citation
Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8.
Results Reference
derived
PubMed Identifier
33548194
Citation
Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)
We'll reach out to this number within 24 hrs