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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352608
Recruitment Status : Active, not recruiting
First Posted : April 20, 2020
Last Update Posted : July 29, 2021
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 Biological: Three doses of medium 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 Biological: Three doses of placebo at the emergency vaccination schedule Biological: Three doses of medium 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 Biological: Three 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. 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 .

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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
Actual Primary Completion Date : July 10, 2020
Estimated Study Completion Date : September 30, 2021

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




Primary Outcome Measures :
  1. Safety indexes of adverse reactions [ Time Frame: From Day 0 to Day 28 after each dose ]
    Incidence of adverse reactions occured from Day 0 to Day 28 after each dose

  2. Immunogenicity indexes of neutralizing-antibody seroconversion rates [ Time Frame: 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 :
  1. Safety indexes of adverse reactions [ Time Frame: 7 days after each dose of vaccination ]
    Incidence of adverse reactions 7 days after each dose of vaccination

  2. Safety indexes of Incidence of abnormal laboratory index [ Time Frame: 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

  3. Safety indexes of serious adverse events (SAEs) [ Time Frame: 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

  4. Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies [ Time Frame: 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

  5. Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies [ Time Frame: 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)

  6. Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ [ Time Frame: 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)

  7. Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ [ Time Frame: 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)

  8. Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ [ Time Frame: 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)

  9. Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ [ Time Frame: 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)

  10. Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies [ Time Frame: 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)

  11. Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies [ Time Frame: 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)



Information from the National Library of Medicine

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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


Locations
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China, Jiangsu
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China, 221200
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 29, 2021
Last Verified: July 2021

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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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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs