COVID-19
Conditions
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.
Interventions
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.
BIOLOGICALTwo doses of high 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..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.
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.
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.
Sponsors
Sinovac Life Sciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety index-incidence of adverse reactions | Day 0-28 after each dose vaccination | Incidence of adverse reactions after each dose vaccination |
| Immunogenicity index-seroconversion rates of neutralizing antibody | 28 days after the second dose vaccination | The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety index-incidence rate of adverse reactions | within 7 days after each dose vaccination | Incidence rate of adverse reactions within 7 days after each dose vaccination |
| Safety index-incidence rate of serious adverse events in phase Ⅰ | From the beginning of the vaccination to 6 months after the booster immunization | 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 | From the beginning of the vaccination to 12 months after the booster immunization vaccination | 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 | 28 days after the second dose vaccination | 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 | 28 days after the first dose vaccination in phase Ⅰ | The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the first dose vaccination in phase Ⅰ |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity index -seropositive rate and GMT of neutralizing antibodies | 6 months after the second dose vaccination | The seropositive rate and GMT 6 months after the second dose vaccination |
| Immunogenicity index -seropositive rate, GMT, and GMI of neutralizing antibodies | 28 days after the booster vaccination | The seropositive rate, GMT, and GMI 28 days after the booster vaccination in phase Ⅰ |
| Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅰ | 12 months after the second dose vaccination | The seropositive rate and GMT 12 months after the second dose vaccination in phase Ⅰ |
| Immunogenicity index -seropositive rate, GMT of neutralizing antibodies in phase Ⅱ | 7 days (or 14 days) and 28 days after the booster vaccination | The seropositive rate, GMT, and GMI 7 days (or 14 days) and 28 days after the booster vaccination in phase Ⅱ |
| Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅱ | 12 months after the booster vaccination | The seropositive rate and GMT 12 months after the booster vaccination in phase Ⅱ |
| Immunogenicity index-seropositive rate,GMT and GMI of neutralizing antibodies | 14 days after the fourth dose | The seropositive rate, GMT and GMI of neutralizing antibody against CZ, Delta and Omicron antigens 14 days after the fourth dose. |
| Immunogenicity index-Seropositive rate and GMTof neutralizing antibodies | 6 months after the fourth dose | The seropositive rate and GMT of neutralizing antibody against Delta and Omicron antigens 6 months after the fourth dose. |
Countries
China
Outcome results
None listed