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.
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 .
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.
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.
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.
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.
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
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.
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
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
Biological: Three doses of placebo at the emergency vaccination schedule
Three doses of placebo at the schedule of day 0,14,42
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
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
Biological: Three doses of placebo at the routine vaccination schedule
Three doses of placebo at the schedule of day 0,28,56
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:
- Travel history / residence history of Wuhan city and surrounding areas, or other
communities with case reports within 14 days;
- History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within
14 days;
- Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding
areas, or from communities with case reports within 14 days;
- 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;
- Positive in serum antibodies (IgG or IgM) screening of COVID-19;
- Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
- Women who are breastfeeding, pregnant or planning to become pregnant during the study
period;
- BMI≥35 kg/m2;
- 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;
- Congenital malformations or developmental disorders, genetic defects, severe
malnutrition, etc.;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension
and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant
tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- 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;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding
allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis
superficial corticosteroid therapy) in the past 6 months;
- 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);
- History of alcohol or drug abuse;
- Receipt of blood products within 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;
- 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.
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Fengcai Zhu, Doctor, Principal Investigator
Jiangsu Provincial Center for Disease Control and Prevention