Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)

NCT05574985 | Completed

• 1 other identifier: LKM-2022-DO-NCV-01
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

Popular topic:A Clinical Study of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) Overall design:The study was designed as a randomized, open and controlled study. Study population: People aged 18 years and above and 6-15 months after the completion of basic immunization or 6-9 months after the completion of enhanced immunization with the new coronal prototype vaccine. Test groups:Study group；Control group；Observation group ①；Observation group ②

Conditions

COVID-19

Keywords

Recombinant Vaccine; Omicron-Delta

Outcome Measures

Primary Outcomes (3)

• Immunogenicity end point 1

  Blood samples were collected from subjects on the 14th day after vaccination, and serum was obtained after centrifugation. Then, the geometric mean titer (GMT) of neutralizing antibodies against COVID-19 variants (Delta, Omicron BA.2，Omicron BA.5) was obtained from the serum samples of subjects on the 14th day after vaccination.

  14 days after vaccination

• Safety end point 1

  The contact card was recovered on the 28th day after vaccination, and the clinician determined whether there was an adverse event and entered it into the EDC system. After statistical analysis, the incidence of all adverse events within 28 days was determined.

  28 days after vaccination

• Safety end point 2

  At the end of 6 months after vaccination, through telephone follow-up, the clinician learned whether the subject had serious adverse events, entered the information into the EDC system, and determined the incidence of all serious adverse events within 6 months through statistical analysis.

  6 months after vaccination

Secondary Outcomes (1)

• Immunogenicity end point 4

  6 months after vaccination

Study Arms (4)

Research Group

EXPERIMENTAL

People 6 to 15 months after the completion of basic immunization with inactivated COVID-19 vaccine were vaccinated one dose of the study vaccine

Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)

Control Group

ACTIVE COMPARATOR

People 6 to 15 months after the completion of basic immunization with inactivated COVID-19 vaccine were vaccinated with one dose of control vaccine

Biological: Inactivated COVID-19 vaccine (Vero Cell)

Observation group ①

EXPERIMENTAL

People 6 to 9 months after the completion of the inactivated COVID-19 vaccine booster immunization were vaccinated one dose of the study vaccine

Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)

Observation group ②

EXPERIMENTAL

People 6 to 15 months after the completion of basic immunization with COVID-19 recombinant vaccine were vaccinated one dose of the study vaccine

Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)

Interventions

Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) BIOLOGICAL

Injected one dose of research vaccine

Observation group ①; Observation group ②; Research Group

Inactivated COVID-19 vaccine (Vero Cell) BIOLOGICAL

Injected one dose of control vaccine

Control Group

Eligibility Criteria

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

You may qualify if:

• At the time of signing the Informed Consent, he was 18 years old or above;
• Normal body temperature (axillary temperature \< 37.3 ℃/oral temperature \< 37.5 ℃);
• Meet one of the following conditions: 1) 6-15 months after the basic immunization (2 injections) of the inactivated vaccine of the prototype strain of COVID-19-19 has been completed; 2) 6-9 months after the booster immunization (3 injections) of the inactivated vaccine of the prototype strain of COVID-19 has been completed; 3) 6-15 months after basic immunization (3 injections) of recombinant vaccine of COVID-19 prototype strain has been completed.
• The vaccines used to complete the above basic immunization or enhanced immunization were produced by Beijing Biotech, Wuhan Biotech, Sinovac and Zhifeilong Koma, and the same kind of vaccine was inoculated throughout the whole process.
• Female subjects over 18 years old were not pregnant (blood pregnancy test was negative), were not in lactation and took effective contraceptive measures within 4 weeks after inoculation; The male subject must agree to take effective contraceptive measures by himself and his partner within 4 weeks after signing the informed consent and vaccination.
• Subjects have the ability to understand the research procedure, voluntarily sign the informed consent form after informed consent, can comply with the requirements of the clinical research protocol, and can and is willing to complete the entire required research plan.

You may not qualify if:

• A history of serious allergy to any vaccine in the past, or a history of serious allergy to any component of the studied vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, allergic constitution (such as allergic to two or more drugs, food or pollen);
• Confirmed cases of novel coronavirus infection, asymptomatic infections or positive history of novel coronavirus nucleic acid testing;
• Patients with uncontrollable lymphoproliferative disease, aplastic anemia, primary immune thrombocytopenia (ITP), and haemorrhagic disease;
• A history of congenital or acquired immunodeficiency or autoimmune diseases;
• The life expectancy of patients with malignant tumors is less than 1 year;
• Patients with uncontrolled epilepsy and other progressive nervous system diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
• Patients with acute disease, or acute attack period of chronic disease, or uncontrolled severe chronic disease, such as hypertension beyond the control of drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
• Those who have received inactivated vaccine within one week or attenuated vaccine within four weeks before vaccination;
• Subjects who have participated in other clinical studies or are participating in other clinical studies within 3 months;
• The investigator believes that the subject has any disease or condition that may put the subject at risk, that the subject cannot complete the study as required by the protocol, and that there are conditions that interfere with the evaluation of vaccine response.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 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

• Huan Zhou, Professor

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 12, 2022
• Study Start: August 29, 2022
• Primary Completion: October 9, 2022
• Study Completion: March 18, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)