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A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above (COVID-19)

Primary Purpose

COVID-19

Status

Active

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Omicron COVID-19 Vaccine (Vero Cell), Inactivated

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Omicron, inactivated vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects aged 18 years old and above.
By asking for medical history and physical examination, the investigator judged - that the health condition is well.
Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

Confirmed or suspected cases of SARS-CoV-2 Infection.
Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
Has received COVID-19 vaccine (include mRNA, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.)
Axillary body temperature > 37.3 ℃ before vaccination
Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred (self-report, on-site inquiry).
History of hospital-diagnosed thrombocytopenia or other coagulation disorder
Known immunological impairment or low level with hospital diagnosis
History of uncontrolled epilepsy, other progressive neurological disorders, or Guillain-Barre syndrome (self-report, on-site inquiry).
Known or suspected concomitant serious diseases include: respiratory disease, acute infection or active chronic disease, liver and kidney disease, severe diabetes, malignant tumor, infection or allergic skin disease, HIV infection.
Severe cardiovascular disease (cardiopulmonary failure, uncontrolled hypertension, etc.) diagnosed by the hospital, active chronic respiratory disease
Live attenuated vaccine is inoculated within 1 month before this vaccination
other vaccines are inoculated within 14 days before this vaccination.
be participating in or plan to participate in other vaccine clinical trials during this study.
Contraindications related to vaccination as considered by other investigators.

Sites / Locations

Shulan (hangzhou) Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

subjects aged 18-59 years old

subjects aged 60 years old and above

Arm Description

Outcomes

Primary Outcome Measures

The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2

The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2

Incidence of adverse reactions

Secondary Outcome Measures

The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2

The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2

The incidence of any adverse reactions/events

The incidence of serious adverse events (SAE) and adverse events special interest (AESI)

The neutralizing antibody GMT

The proportion of subjects of neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64

Full Information

NCT ID

NCT05365724

First Posted

April 30, 2022

Last Updated

June 15, 2023

Sponsor

China National Biotec Group Company Limited

Collaborators

Beijing Institute of Biological Products Co Ltd., Shulan (Hangzhou) Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05365724

Brief Title

A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above

Acronym

COVID-19

Official Title

A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above With no Vaccination History of COVID-19 Vaccine

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China National Biotec Group Company Limited

Collaborators

Beijing Institute of Biological Products Co Ltd., Shulan (Hangzhou) Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above with no vaccination history of the COVID-19 vaccine. 200 health subjects will be recruited in this study, including 150 aged 18-59 years old and 50 aged 60 years old and above. All subjects will be received 2 doses of Omicron COVID-19 Vaccine (Vero Cell), Inactivated according to the immunization schedule of 0, 21-28 days. The change in neutralizing antibody level at 28 days after the second dose was used to determine whether to receive a further booster dose for ≥3 months. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on Day 0 before vaccination,Day 14 after dose 1, before dose 2 and on day 14, 28 and month 3, 6, 9, 12 after dose 2. Serum antibody levels, cellular immune responses will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, Omicron, inactivated vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Arm Title

subjects aged 18-59 years old

Arm Type

Experimental

Arm Title

subjects aged 60 years old and above

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Omicron COVID-19 Vaccine (Vero Cell), Inactivated

Intervention Description

2 doses of vaccine according to the immunization schedule of 0, 21-28 days

Primary Outcome Measure Information:

Title

The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2

Time Frame

On Day 28 after Dose 2

Title

The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2

Time Frame

On Day 28 after Dose 2

Title

Incidence of adverse reactions

Time Frame

within 28 days after vaccination

Secondary Outcome Measure Information:

Title

The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2

Time Frame

On Day 14 after Dose 2

Title

The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2

Time Frame

On Day 14 after Dose 2

Title

The incidence of any adverse reactions/events

Time Frame

28 days after each immunization

Title

The incidence of serious adverse events (SAE) and adverse events special interest (AESI)

Time Frame

From the beginning of the first dose to 12 months after the second immunization

Title

The neutralizing antibody GMT

Time Frame

on 3rd month, 6th month, 9th month, and 12th month after Dose 2

Title

The proportion of subjects of neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64

Time Frame

on 3rd month, 6th month, 9th month, and 12th month after Dose 2

Other Pre-specified Outcome Measures:

Title

The neutralizing antibody GMT to different variants of SARS-CoV-2

Time Frame

On Day 28 after Dose 2

Title

The IgG antibody lever against Omicron SARS-CoV-2

Time Frame

On Day 14 and 28 after Dose 2

Title

The incidence of COVID-19 cases

Time Frame

From 14 day after Dose 2

Title

The incidence of severe cases of COVID-19, including deaths accompanied by COVID-19)

Time Frame

From 14 day after Dose 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects aged 18 years old and above. By asking for medical history and physical examination, the investigator judged - that the health condition is well. Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan. With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol. Exclusion Criteria: Confirmed or suspected cases of SARS-CoV-2 Infection. Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry). Has received COVID-19 vaccine (include mRNA, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.) Axillary body temperature > 37.3 ℃ before vaccination Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred (self-report, on-site inquiry). History of hospital-diagnosed thrombocytopenia or other coagulation disorder Known immunological impairment or low level with hospital diagnosis History of uncontrolled epilepsy, other progressive neurological disorders, or Guillain-Barre syndrome (self-report, on-site inquiry). Known or suspected concomitant serious diseases include: respiratory disease, acute infection or active chronic disease, liver and kidney disease, severe diabetes, malignant tumor, infection or allergic skin disease, HIV infection. Severe cardiovascular disease (cardiopulmonary failure, uncontrolled hypertension, etc.) diagnosed by the hospital, active chronic respiratory disease Live attenuated vaccine is inoculated within 1 month before this vaccination other vaccines are inoculated within 14 days before this vaccination. be participating in or plan to participate in other vaccine clinical trials during this study. Contraindications related to vaccination as considered by other investigators.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lanjuan Li

Organizational Affiliation

Shulan (Hangzhou) Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shulan (hangzhou) Hospital

City

Hangzhou

State/Province

Zhejiang

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above

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