Omicron BA.4/5-Delta COVID-19 Vaccine Phase I Clinical Trial

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) in People Aged 18 Years and Above.

The purpose of this study is to evaluate the safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) after vaccination in people aged 18 and over. It is planned to screen 100 subjects who are 18 years old and above and more than 6 months since the last new coronavirus infection or new coronavirus vaccine. All subjects collected venous blood before vaccination, 14 days, 3 months, and 6 months after vaccination for immunological detection of neutralizing antibody of the new coronavirus prototype strain, Delta strain and Omicron strain (BA.4/5, XBB); All adverse events (AEs) within 30 minutes after vaccination, all AEs (including solicited and non-solicited AEs) on days 0-7, all AEs (non-solicited AEs) on days 8-30, and all AEs within 12 months after vaccination were collected. serious adverse events (SAE) and adverse events of special interest (AESI).

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells); Biological: Placebo

Detailed Description

Solicitation AEs (the following events occurring within 7 days of vaccination):

AESI:

Select 100 cases of people aged 18 years and above and more than 6 months after the last new coronavirus infection or vaccination, and evaluate the effectiveness of Omicron BA.4/5-Delta strain recombinant new coronavirus protein vaccine (CHO cells) in people aged 18 years and above. Safety after vaccination in the population.

Non-vaccination site (systemic) adverse events: fever, headache, fatigue/asthenia, nausea, vomiting, diarrhea, myalgia (non-vaccination site), cough, acute allergic reaction.

Venous blood was collected from all subjects before vaccination, 14 days, 3 months, and 6 months after vaccination for immunological detection of neutralizing antibodies against the new coronavirus prototype strain, Delta strain, and Omicron strain (BA.4/5, XBB).

Adverse events at the vaccination site (local): pain, swelling, induration, redness, rash, itching; Myocarditis/pericarditis, thrombosis, thrombocytopenia, etc., immune-related diseases (psoriasis, rheumatoid arthritis, etc.), nervous system-related diseases (Glibari syndrome, peripheral neuropathy, Bell's palsy).

Pregnancy events that occurred within 12 months after vaccination of subjects in this trial were collected, and neonates whose pregnancy outcome was delivery during the study period were followed up for long-term safety (follow-up until 12 months after delivery).

Immunogenicity observation:

Safety observations:

AEs, AESIs and SAEs: collect all adverse events (AEs) 30 minutes after vaccination, all AEs 0-7 days (including solicited and non-solicited AEs), 8-30 days all AEs (non-solicited AEs), vaccination All serious adverse events (SAEs) and adverse events of special interest (AESIs) within the last 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Junshi Zhao, Master; Phone Number: 17788903138; Email: ymlc02@hncdc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 18 and above when signing the informed consent form;
• The subject himself voluntarily participates in this research, and signs the informed consent form, and can provide legal identification, understand and abide by the requirements of the trial protocol;
• Female subjects of childbearing age and male subjects must agree to take effective contraceptive measures during the study.

Exclusion Criteria:

• Less than 6 months since the last COVID-19 infection or COVID-19 vaccination；
• Prior history of severe allergy to any vaccine, or to any component of the experimental vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, allergy (such as allergy to two or more drugs, food or pollen);
• Suspected or confirmed fever (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃) within 72 hours before enrollment, or axillary body temperature ≥37.3℃/ mouth temperature ≥37.5℃ on the day of enrollment;
• Patients with uncontrolled lymphoproliferative disease, unmitigated aplastic anemia, primary immune thrombocytopenia (ITP) activity, uncontrolled coagulation disease, etc.;
• a history of congenital or acquired immunodeficiency or autoimmune disease; Absence of spleen, or history of splenic surgery, trauma or immunomodulator treatment within 6 months, such as immunosuppressive dose of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day for more than a week); Or monoclonal antibodies; Thymosin; Or interferon; Topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted;
• Non-live vaccine should be administered within 14 days before vaccination, and live attenuated vaccine should be administered within 30 days;
• Patients with malignant tumors who are undergoing chemotherapy, radiotherapy, immunotherapy, etc., before and after surgery; Patients with organ transplant status;
• People with uncontrolled epilepsy and other progressive neurological disorders (e.g. Transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
• Patients with acute disease, or acute onset of chronic disease, or uncontrolled severe chronic disease, such as medically uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
• Participants who had used blood and blood-related products within 3 months prior to enrollment;
• Participants who have participated in or are participating in other clinical trials (including drugs and devices) within 3 months prior to the clinical trial;
• Women of childbearing age have had unprotected sexual activity within 14 days prior to enrollment
• lactating women or women during pregnancy;
• The investigator determined that the subject had any disease or condition that would put the subject at risk, that the subject would not be able to complete the trial as required by the protocol, or that there would be conditions that would interfere with the evaluation of vaccine response.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cell)	Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells); Inoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm
Placebo Comparator: Group 2; physiological saline	Biological: Placebo; Inoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint	Incidence of AEs&SAE&AESI	Within 12 months after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity endpoint	Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody	14 days after vaccination

Collaborators and Investigators

• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Collaborators: Hunan Provincial Center for Disease Control and Prevention
• Investigators: Principal Investigator: Junshi Zhao, Master, Hunan Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LKM-2023-NCV-V04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No