Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
Study Details
Study Description
Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ 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 adults aged 18~59 Years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ. All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28 and one dose of booster immunization will be given 6 months after primary immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or 0,28,56 .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Emergency schedule & Two doses of medium dosage vaccine 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the emergency schedule |
Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
|
| Experimental: Emergency schedule & Two doses of high dosage vaccine 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the emergency schedule |
Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
|
| Placebo Comparator: Emergency schedule &Two doses of placebo 24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the emergency vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the emergency schedule |
Biological: Two doses of placebo at the emergency vaccination schedule
Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.
|
| Experimental: Routine schedule & Two doses of medium dosage vaccine 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the routine schedule |
Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.
|
| Experimental: Routine schedule &Two doses of high dosage vaccine 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the routine schedule |
Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ
|
| Placebo Comparator: Routine schedule & Two doses of placebo 24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the routine vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the routine schedule |
Biological: Two doses of placebo at the routine vaccination schedule
Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.
|
| Experimental: Emergency schedule & Three doses of medium dosage vaccine 60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule |
Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
|
| Experimental: Emergency schedule & Three doses of high dosage vaccine 60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule |
Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
|
| Placebo Comparator: Emergency schedule &Three doses of placebo 30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule |
Biological: Three doses of placebo at the emergency vaccination schedule
Three doses of placebo at the schedule of day 0,14,42
|
| Experimental: Routine schedule & Three doses of medium dosage vaccine 60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule |
Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
|
| Experimental: Routine schedule &Three doses of high dosage vaccine 60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule |
Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
|
| Placebo Comparator: Routine schedule &Three doses of placebo 30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule |
Biological: Three doses of placebo at the routine vaccination schedule
Three doses of placebo at the schedule of day 0,28,56
|
Outcome Measures
Primary Outcome Measures
- Safety indexes of adverse reactions [From Day 0 to Day 28 after each dose]
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
- Immunogenicity indexes of neutralizing-antibody seroconversion rates [The 14th day /the 28th day after two doses of vaccination]
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
Secondary Outcome Measures
- Safety indexes of adverse reactions [7 days after each dose of vaccination]
Incidence of adverse reactions 7 days after each dose of vaccination
- Safety indexes of Incidence of abnormal laboratory index [On the 3th day after each dose of vaccination in phase Ⅰ]
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 Ⅰ
- Safety indexes of serious adverse events (SAEs） [From the beginning of the vaccination to 6 months post the whole-schedule vaccination]
Incidence of SAEs from the beginning of the vaccination to 6 months post the whole-schedule vaccination
- Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies [14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination]
The seropositive rate, GMT, and GMI of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies [28 days after the two doses (emergency schedule)]
The seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies 28 days after the two doses (emergency schedule)
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ [28 days after the third dose （only for days 0,14,42 and days 0,28,56 schedule）]
Phase Ⅱ:The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the third dose（only for days 0,14,42 and days 0,28,56 schedule）
- Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ [14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）]
Phase Ⅱ:The seropositivity rate, GMT, and GMI 14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ [7/14/21 days after the first dose vaccination (emergency schedule)]
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 7/14/21 days after the first dose vaccination (emergency schedule)
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ [28/35/42 days after the first dose vaccination (routine schedules)]
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 28/35/42 days after the first dose vaccination (routine schedules)
- Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies [7/14/21/28/42 days after the first dose vaccination (emergency schedule)]
Phase Ⅰ:The seropositive rate of IgG, IgM antibodies 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
- Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies [28/35/42/56 days after the first dose vaccination (routine schedule)]
Phase Ⅰ: The seropositive rate of IgG,IgM antibodies 28/35/42/56 days after the first dose vaccination (routine schedule)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adults aged 18-59 years;
-
Proven legal identity;
-
Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
Exclusion Criteria:
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Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
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History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
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Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
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Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
-
Self-reported history of SARS;
-
Self-reported history of new coronavirus infection;
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Positive in serum antibodies (IgG or IgM) screening of COVID-19;
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Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
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Women who are breastfeeding, pregnant or planning to become pregnant during the study period;
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BMI≥35 kg/m2;
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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;
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Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
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Autoimmune disease or immunodeficiency / immunosuppression;
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Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.;
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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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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;
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Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
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Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials);
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History of alcohol or drug abuse;
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Receipt of blood products within in the past 3 months;
-
Receipt of other investigational drugs in the past 30 days;
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Receipt of attenuated live vaccines in the past 14 days;
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Receipt of inactivated or subunit vaccines in the past 7 days;
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Attacks of acute diseases or 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 participating in the clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Suining County Center for Disease Control and Prevention | Xuzhou | Jiangsu | China | 221200 |
Sponsors and Collaborators
- Sinovac Research and Development Co., Ltd.
Investigators
- Principal Investigator: Fengcai Zhu, Doctor, Jiangsu Provincial Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-1001