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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352608
• Other study ID #: PRO-nCOV-1001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 16, 2020
• Est. completion date: July 24, 2021

Study information

• Verified date: July 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: July 24, 2021
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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 phase?.
• 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 phase?.
• 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 phase?.
• 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 phase?.
• 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 phase?
• 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 phase?.
• 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
• 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
• Three doses of placebo at the emergency vaccination schedule
Three doses of placebo at the schedule of day 0,14,42
• 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
• 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
• Three doses of placebo at the routine vaccination schedule
Three doses of placebo at the schedule of day 0,28,56

Locations

Country	Name	City	State
China	Suining County Center for Disease Control and Prevention	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety indexes of adverse reactions	Incidence of adverse reactions occured from Day 0 to Day 28 after each dose	From Day 0 to Day 28 after each dose
Primary	Immunogenicity indexes of neutralizing-antibody seroconversion rates	The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.	The 14th day /the 28th day after two doses of vaccination
Secondary	Safety indexes of adverse reactions	Incidence of adverse reactions 7 days after each dose of vaccination	7 days after each dose of vaccination
Secondary	Safety indexes of Incidence of abnormal laboratory index	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 ?	On the 3th day after each dose of vaccination in phase ?
Secondary	Safety indexes of serious adverse events (SAEs)	Incidence of SAEs from the beginning of the vaccination to 6 months post the whole-schedule vaccination	From the beginning of the vaccination to 6 months post the whole-schedule vaccination
Secondary	Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies	The seropositive rate, GMT, and GMI of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination	14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Secondary	Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies	The seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies 28 days after the two doses (emergency schedule)	28 days after the two doses (emergency schedule)
Secondary	Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase ?	Phase ?: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)	28 days after the third dose (only for days 0,14,42 and days 0,28,56 schedule)
Secondary	Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase ?	Phase ?: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)	14 day (emergency schedule)/28 days (routine schedule) after the booster dose (only for days 0,14 and days 0,28 schedule)
Secondary	Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase ?	Phase ?:The seroconversion rate, seropositive rate, GMT, and GMI 7/14/21 days after the first dose vaccination (emergency schedule)	7/14/21 days after the first dose vaccination (emergency schedule)
Secondary	Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase ?	Phase ?:The seroconversion rate, seropositive rate, GMT, and GMI 28/35/42 days after the first dose vaccination (routine schedules)	28/35/42 days after the first dose vaccination (routine schedules)
Secondary	Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies	Phase ?:The seropositive rate of IgG, IgM antibodies 7/14/21/28/42 days after the first dose vaccination (emergency schedule)	7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Secondary	Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies	Phase ?: The seropositive rate of IgG,IgM antibodies 28/35/42/56 days after the first dose vaccination (routine schedule)	28/35/42/56 days after the first dose vaccination (routine schedule)