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Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352608
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

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
COVID-19 Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Biological: Two doses of placebo at the emergency vaccination schedule Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Biological: Two doses of placebo at the routine vaccination schedule 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. Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : August 13, 2020
Estimated Study Completion Date : December 13, 2020

Arm Intervention/treatment
Experimental: Emergency schedule & Medium dosage vaccine
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination 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

Experimental: Emergency schedule & High dosage vaccine
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination 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

Placebo Comparator: Emergency schedule & Placebo
Two doses of placebo at the emergency vaccination schedule
Biological: Two doses of placebo at the emergency vaccination schedule
Two doses of placebo at the schedule of day 0,14

Experimental: Routine schedule & Medium dosage vaccine
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination 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

Experimental: Routine schedule & High dosage vaccine
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination 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

Placebo Comparator: Routine schedule & Placebo
Two doses of placebo at the routine vaccination schedule
Biological: Two doses of placebo at the routine vaccination schedule
Two doses of placebo at the schedule of day 0,28




Primary Outcome Measures :
  1. Safety indexes of adverse reactions [ Time Frame: From the beginning of the vaccination to 28 days after the whole schedule vaccination ]
    Occurence of adverse reactions post vaccination

  2. Immunogenicity indexes of neutralizing-antibody seroconversion rates for the emergency vaccination schedule (day 0,14) [ Time Frame: The 14th day after two doses of vaccination ]
    The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum

  3. Immunogenicity indexes of neutralizing-antibody seroconversion rates for the routine vaccination schedule (day 0,28) [ Time Frame: The 28th day after two doses of vaccination ]
    The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum


Secondary Outcome Measures :
  1. Safety indexes of adverse reactions [ Time Frame: 0~7 days after each dose injection ]
    Occurence of adverse reactions post vaccination

  2. Occurrence of abnormal changes of laboratory safety examinations (hemoglobin,WBCs, platelets, ALT, AST, total bilirubin, creatinine, creatine phosphokinase, urine protein, urine sugar, urinary erythrocyte) [ Time Frame: The 3rd day after each dose injection ]
    Safety index, abnormal changes will be defined as any one of the lab indexes experiencing changes out of clinical reference value range.

  3. Safety indexes of serious adverse events (SAEs) [ Time Frame: From the beginning of the vaccination to 6 months after two doses of vaccination ]
    Occurence of SAEs post vaccination

  4. Immunogenicity indexes of neutralizing-antibody seroconversion rates [ Time Frame: 7,14,21,42 days after the first dose injection for emergency vaccination schedule and 28,35,42 days after the first dose injection for the routine vaccination schedules ]
    The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum

  5. Immunogenicity indexes of IgG antibody seropositivity rates [ Time Frame: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule ]
    The seropositivity rates of IgG antibody tested by ELISA serum

  6. Immunogenicity indexes IgM antibody seropositivity rates [ Time Frame: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule ]
    The seropositivity rates of IgM antibody tested by ELISA serum

  7. Immunogenicity indexes of GMT of neutralizing-antibody [ Time Frame: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule ]
    The GMT of neutralizing antibody against 2019 novel coronavirus tested by micro-neutralization assay in serum

  8. Immunogenicity indexes of GMR of neutralizing-antibody [ Time Frame: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule ]
    The GMR of neutralizing antibody against 2019 novel coronavirus tested by micro-neutralization assay in serum


Other Outcome Measures:
  1. Immunogenicity indexes of cellular immune [ Time Frame: The 14th day after each dose vaccination ]
    specific cellular immune responses

  2. Immunogenicity indexes of neutralizing-antibody persistence [ Time Frame: 6 months after two doses of vaccination ]
    he seropositivity rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum

  3. Immunogenicity indexes of neutralizing-antibody GMT [ Time Frame: 6 months after two doses of vaccination ]
    The GMT of neutralizing antibody against 2019 novel coronavirus tested by micro-neutralization assay in serum

  4. Safety indexes-Seropositivity rates of antinuclear antibody [ Time Frame: The 7th day after each dose injection ]
    Seropositivity rates of antinuclear antibody in serum

  5. Safety indexes-Level of Inflammatory factors [ Time Frame: The 7th day after each dose injection ]
    Level of Inflammatory factors in serum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352608


Contacts
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Contact: Fengcai Zhu, Doctor 86-18118996996 jszfc@vip.sina.com
Contact: Hongxing Pan, Doctor 86-18118996996 panhongxing@126.com

Locations
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China, Jiangsu
Suining County Center for Disease Control and Prevention Recruiting
Xuzhou, Jiangsu, China, 221200
Contact: Congbing Jiang, Bachelor    86-18751728180    413659915@qq.com   
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Fengcai Zhu, Doctor Jiangsu Provincial Center for Disease Control and Prevention
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04352608    
Other Study ID Numbers: PRO-nCOV-1001
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs