Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05365724
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : May 9, 2022
Sponsor:
Collaborators:
Beijing Institute of Biological Products Co Ltd.
Shulan Hospital of Hangzhou
Information provided by (Responsible Party):
China National Biotec Group Company Limited

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.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: subjects aged 18-59 years old Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
2 doses of vaccine according to the immunization schedule of 0, 21-28 days

Experimental: subjects aged 60 years old and above Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
2 doses of vaccine according to the immunization schedule of 0, 21-28 days




Primary Outcome Measures :
  1. The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 28 after Dose 2 ]
  2. The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 28 after Dose 2 ]
  3. Incidence of adverse reactions [ Time Frame: within 28 days after vaccination ]

Secondary Outcome Measures :
  1. The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 14 after Dose 2 ]
  2. The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2 [ Time Frame: On Day 14 after Dose 2 ]
  3. The incidence of any adverse reactions/events [ Time Frame: 28 days after each immunization ]
  4. 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 ]
  5. The neutralizing antibody GMT [ Time Frame: on 3rd month, 6th month, 9th month, and 12th month after Dose 2 ]
  6. 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 Outcome Measures:
  1. The neutralizing antibody GMT to different variants of SARS-CoV-2 [ Time Frame: On Day 28 after Dose 2 ]
  2. The IgG antibody lever against Omicron SARS-CoV-2 [ Time Frame: On Day 14 and 28 after Dose 2 ]
  3. The incidence of COVID-19 cases [ Time Frame: From 14 day after Dose 2 ]
  4. The incidence of severe cases of COVID-19, including deaths accompanied by COVID-19) [ Time Frame: From 14 day after Dose 2 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05365724


Contacts
Layout table for location contacts
Contact: Guiling Chen, PhD +86 571 56097873 chenguiling707@126.com

Locations
Layout table for location information
China, Zhejiang
Shulan (hangzhou) Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Guiling Chen, PhD         
Sponsors and Collaborators
China National Biotec Group Company Limited
Beijing Institute of Biological Products Co Ltd.
Shulan Hospital of Hangzhou
Investigators
Layout table for investigator information
Principal Investigator: Lanjuan Li Shulan Hospital of Hangzhou
Layout table for additonal information
Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT05365724    
Other Study ID Numbers: CNBG-BIBP-O-2022003
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Biotec Group Company Limited:
COVID-19
Omicron
inactivated vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases