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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 March 2022
• Main ID: NCT04352608
• Date of registration: 14/04/2020
• Prospective Registration: Yes
• Primary sponsor: Sinovac Research and Development Co., Ltd.
• Public title: Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
• Scientific title: A Randomized, Double-Blinded, Placebo-Controlled, Phase ?/? Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years
• Date of first enrolment: April 16, 2020
• Target sample size: 744
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04352608
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Fengcai Zhu, Doctor
• Affiliation: Jiangsu Provincial Center for Disease Control and Prevention

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 59 Years
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19

Intervention(s)

Biological: Three doses of placebo at the routine vaccination schedule

Biological: Two doses of placebo at the emergency vaccination schedule

Biological: Two doses of high 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

Biological: Two 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: Two doses of placebo 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 emergency vaccination schedule

Biological: Two doses of high 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

Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule

Primary Outcome(s)

Safety indexes of adverse reactions [Time Frame: From Day 0 to Day 28 after each dose]

Immunogenicity indexes of neutralizing-antibody seroconversion rates [Time Frame: The 14th day /the 28th day after two doses of vaccination]

Secondary Outcome(s)

Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase ? [Time Frame: 28/35/42 days after the first dose vaccination (routine schedules)]

Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies [Time Frame: 28/35/42/56 days after the first dose vaccination (routine schedule)]

Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies [Time Frame: 28 days after the two doses (emergency schedule)]

Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase ? [Time Frame: 7/14/21 days after the first dose vaccination (emergency schedule)]

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)]

Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase ? [Time Frame: 14 day (emergency schedule)/28 days (routine schedule) after the booster dose (only for days 0,14 and days 0,28 schedule)]

Safety indexes of adverse reactions [Time Frame: 7 days after each dose of vaccination]

Safety indexes of serious adverse events (SAEs) [Time Frame: 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 [Time Frame: 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination]

Safety indexes of Incidence of abnormal laboratory index [Time Frame: On the 3th day after each dose of vaccination in phase ?]

Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase ? [Time Frame: 28 days after the third dose (only for days 0,14,42 and days 0,28,56 schedule)]

Secondary ID(s)

PRO-nCOV-1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors