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

NCT04383574 | Completed Phase 1 DMC

• 1 other identifier: PRO-nCOV-1002
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Safety index-incidence of adverse reactions

  Incidence of adverse reactions after each dose vaccination

  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.

  28 days after the second dose vaccination

Secondary Outcomes (5)

• Safety index-incidence rate of adverse reactions

  within 7 days after each dose vaccination

• Safety index-incidence rate of serious adverse events in phase Ⅰ

  From the beginning of the vaccination to 6 months after the booster immunization

• Safety index-incidence rate of serious adverse events in phase Ⅱ

  From the beginning of the vaccination to 12 months after the booster immunization vaccination

• Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies

  28 days after the second dose vaccination

• Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ

  28 days after the first dose vaccination in phase Ⅰ

Other Outcomes (8)

• Immunogenicity index -seropositive rate and GMT of neutralizing antibodies

  6 months after the second dose vaccination

• Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅰ

  12 months after the second dose vaccination

• Immunogenicity index -seropositive rate, GMT, and GMI of neutralizing antibodies

  28 days after the booster vaccination

Study Arms (4)

Experimental Vaccine-medium dosage

EXPERIMENTAL

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 Vaccine-high dosage

EXPERIMENTAL

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

PLACEBO COMPARATOR

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 Vaccine-low dosage

EXPERIMENTAL

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

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 BIOLOGICAL

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.

Experimental Vaccine-medium dosage

Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 BIOLOGICAL

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.

Experimental Vaccine-high dosage

Two doses of placebo at the schedule of day 0,28 BIOLOGICAL

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.

Placebo

Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 BIOLOGICAL

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.

Experimental Vaccine-low dosage

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Renqiu City Center for Disease Control and Prevention

Renqiu, Hebei, 062550, China

Location

Related Publications (3)

• 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.

  PMID: 35660738 DERIVED

• 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.

  PMID: 34890537 DERIVED

• 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.

  PMID: 33548194 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuliang Zhao, Master

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 12, 2020
• Study Start: May 22, 2020
• Primary Completion: December 28, 2021
• Study Completion: May 31, 2022
• Last Updated: August 11, 2022

Record last verified: 2021-07

Locations

CN (1)