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

NCT05365724 | Unknown Phase 1

• 1 other identifier: CNBG-BIBP-O-2022003
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Omicron; inactivated vaccine

Outcome Measures

Primary Outcomes (3)

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

  On Day 28 after Dose 2

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

  On Day 28 after Dose 2

• Incidence of adverse reactions

  within 28 days after vaccination

Secondary Outcomes (6)

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

  On Day 14 after Dose 2

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

  On Day 14 after Dose 2

• The incidence of any adverse reactions/events

  28 days after each immunization

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

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

• The neutralizing antibody GMT

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

Other Outcomes (4)

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

  On Day 28 after Dose 2

• The IgG antibody lever against Omicron SARS-CoV-2

  On Day 14 and 28 after Dose 2

• The incidence of COVID-19 cases

  From 14 day after Dose 2

Study Arms (2)

subjects aged 18-59 years old

EXPERIMENTAL

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

subjects aged 60 years old and above

EXPERIMENTAL

Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated

Interventions

Omicron COVID-19 Vaccine (Vero Cell), Inactivated BIOLOGICAL

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

subjects aged 18-59 years old; subjects aged 60 years old and above

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Shulan (Hangzhou) Hospital: collaborator

Study Sites (1)

Shulan (hangzhou) Hospital

Hangzhou, Zhejiang, China

Location

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

• Lanjuan Li

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 9, 2022
• Study Start: May 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)