CompletedNCT04383574Updated Aug 11, 2022

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

A Phase 1/2 interventional study of Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 in COVID-19, sponsored by Sinovac Life Sciences Co., Ltd.. Completed at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by Sinovac Life Sciences Co., Ltd. · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 422
Allocation: Randomized
Ages: 60 Years and older
Sex: All

Study summary

This study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy elderly aged 60 years and above.

Read the detailed description

This study is a randomized, double-blinded, single-center, placebo-controlled phase 1\&2 clinical trial in healthy elderly aged 60 years and above. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 422 subjects will be enrolled, with 72 in phase 1 and 350 in phase 2. 72 Subjects with 36 in medium-dosage group and 36 in high-dosage group in phase 1 will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and the subjects at each dosage group will be assigned in a 2:1 ratio to receive investigational vaccine or placebo respectively.All enrolled subjects will receive 1 dose of booster immunization 1 year after primary immunization.350 Subjects in phase 2 will receive two doses of primary immunization according to the immunization schedule of day 0,28,the subjects will be assigned in a ratio of 2:2:2:1 to receive the low dosage, medium dosage, high dosage vaccine, or placebo. All enrolled subjects will received 1 dose of booster immunization(the third dose ) 6 months after primary immunization.And subjects in medium-dosage group and high -dosage group will receive the second booster dose (the fourth dose) 1 year after the second dose.

Conditions studied

COVID-19

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 422 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Sinovac Life Sciences Co., Ltd. is the lead sponsor of 26 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 60 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy adults aged ≥60 years;
Be able to understand and sign the informed consent voluntarily;
Provide legal identification;

Exclusion criteria

Exclusion Criteria:

Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
History of SARS;
History of SARS-CoV-2 infection;
History of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
Autoimmune disease or immunodeficiency / immunosuppression;
Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
Serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis;
Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia 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;
Long history of alcohol or drug abuse;
Receipt of blood products 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;
Acute diseases or acute exacerbation of 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 the clinical trial.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 422 participants (actual)

Study arms

Experimental
Experimental Vaccine-medium dosage
24 participants in medium-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in medium-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose ) and the second booster dose (the fourth dose) 1 year after the second dose.
Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Experimental
Experimental Vaccine-high dosage
24 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose .
Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Placebo comparator
Placebo
24 participants including 12 at medium dosage stage and 12 at high dosage in phase Ⅰ will receive two doses of placebo according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 50 participants in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
Biological: Two doses of placebo at the schedule of day 0,28
Experimental
Experimental Vaccine-low dosage
100 participants at low dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

Interventions

BiologicalTwo doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (600SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.
BiologicalTwo doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.
BiologicalTwo doses of placebo at the schedule of day 0,28
The placebo was manufactured by Sinovac Research \& Development Co., Ltd., Two doses of placebo at the schedule of day 0,28,and one dose of booster immunization with placebo 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
BiologicalTwo doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of low dosage (300SU/0.5ml)experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with low dosage (300SU/0.5ml) experimental vaccine 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.

What researchers measure

Primary outcomes

Safety index-incidence of adverse reactions
Incidence of adverse reactions after each dose vaccination
Time frame: Day 0-28 after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination.
Time frame: 28 days after the second dose vaccination

Secondary outcomes

Safety index-incidence rate of adverse reactions
Incidence rate of adverse reactions within 7 days after each dose vaccination
Time frame: within 7 days after each dose vaccination
Safety index-incidence rate of serious adverse events in phase Ⅰ
Incidence rate of SAEs from the beginning of the vaccination to 6 months after the booster immunization in phase Ⅰ
Time frame: From the beginning of the vaccination to 6 months after the booster immunization
Safety index-incidence rate of serious adverse events in phase Ⅱ
Incidence rate of SAEs from the beginning of the vaccination to 12 months after the booster immunization vaccination in phase Ⅱ
Time frame: From the beginning of the vaccination to 12 months after the booster immunization vaccination
Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies
The seropositive rate, GMT, and GMI of neutralizing antibodies 28 days after the second dose vaccination;
Time frame: 28 days after the second dose vaccination
Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ
The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the first dose vaccination in phase Ⅰ
Time frame: 28 days after the first dose vaccination in phase Ⅰ

Other outcomes

Immunogenicity index -seropositive rate and GMT of neutralizing antibodies
The seropositive rate and GMT 6 months after the second dose vaccination
Time frame: 6 months after the second dose vaccination
Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅰ
The seropositive rate and GMT 12 months after the second dose vaccination in phase Ⅰ
Time frame: 12 months after the second dose vaccination
Immunogenicity index -seropositive rate, GMT, and GMI of neutralizing antibodies
The seropositive rate, GMT, and GMI 28 days after the booster vaccination in phase Ⅰ
Time frame: 28 days after the booster vaccination
Immunogenicity index -seropositive rate, GMT of neutralizing antibodies in phase Ⅱ
The seropositive rate, GMT, and GMI 7 days (or 14 days) and 28 days after the booster vaccination in phase Ⅱ
Time frame: 7 days (or 14 days) and 28 days after the booster vaccination
Immunogenicity index -seropositive rate and GMT of neutralizing antibodies
The seropositive rate and GMT 6 months after the booster vaccination
Time frame: 6 months after the booster vaccination
Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅱ
The seropositive rate and GMT 12 months after the booster vaccination in phase Ⅱ
Time frame: 12 months after the booster vaccination
Immunogenicity index-seropositive rate,GMT and GMI of neutralizing antibodies
The seropositive rate, GMT and GMI of neutralizing antibody against CZ, Delta and Omicron antigens 14 days after the fourth dose.
Time frame: 14 days after the fourth dose
Immunogenicity index-Seropositive rate and GMTof neutralizing antibodies
The seropositive rate and GMT of neutralizing antibody against Delta and Omicron antigens 6 months after the fourth dose.
Time frame: 6 months after the fourth dose

Study locations

1 site

Renqiu City Center for Disease Control and Prevention
Renqiu, Hebei 062550, China

References and documents

Publications

Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w. PubMed 35660738 ↗
Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8. PubMed 34890537 ↗
Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3. PubMed 33548194 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04383574
Lead sponsor: Sinovac Life Sciences Co., Ltd.
Responsible party: Sponsor
First posted: May 12, 2020
Start date: May 22, 2020
Primary completion: Dec 28, 2021
Completion: May 31, 2022
Last update: Aug 11, 2022

Study contacts

Yuliang Zhao, Master

principal investigator · Hubei Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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