Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)

Coronavirus Clinical Trial

Official title:

A Randomized, Double-blind, Active-controlled Clinical Study Evaluating the Immunogenicity and Safety of Omicron BA.4/5-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) in People Aged 18 Years and Older With Different Immunization Programs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06025812
• Other study ID #: LKM-2023-NCV-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Contact: Xie Hai Tang
• Phone: 0553-5738350
• Email: xiehaitang[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).

Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older. Secondary purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older.

Overall design: Studies were randomized, double-blind, active-controlled study design.

Study group: There were 160 participants aged 18 years and older, including 80 people aged 60 years and older.

Study group：Among them, 80 subjects were from the "randomized, double-blind, active-controlled clinical study to evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people aged 18 years and older, protocol number: LKM-2023-NCV-02", 40 cases in the study group and 40 cases in the control group, and completed the second dose of vaccine at the 6th month visit to observe immunogenicity and safety. The remaining 80 subjects were randomly blinded to the 1:1 ratio into the research group and the control group and received 2 doses of the experimental vaccine according to the 0-1-month procedure to observe immunogenicity and safety.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 30, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be 18 years of age or older at the time of signing the informed consent form.

2. The subject himself voluntarily participates in the study, signs the informed consent form, and can provide legal identification, understand and comply with the requirements of the research protocol.

3. More than 6 months after completing the basic immunization or booster immunization of the new coronavirus vaccine.

4. Female subjects of childbearing age and male subjects who were able to use effective contraception during the study.

Exclusion Criteria:

Participants were not eligible for study if they had any of the following:

1. Previous history of severe allergy to any vaccine, or history of severe allergy to any component of the study vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, dyspnea, angioedema, allergic constitution (such as allergy to two or more drugs, food or pollen), etc.

2. fever (axillary body temperature= 37.3°C) within 72 hours before enrollment, or axillary body temperature = 37.3°C on the day of enrollment.

3. Patients infected with the new coronavirus within 3 months before enrollment (asymptomatic infection or positive nucleic acid or antigen test of the new coronavirus).

4. Patients with aplastic anemia that has not been relieved, primary immune thrombocytopenia (ITP) active period, and uncontrolled coagulation diseases.

5. history of congenital or acquired immunodeficiency or autoimmune disease; no history of spleen or spleen surgery or trauma; or receive immunomodulators within 6 months, such as corticosteroids in immunosuppressant doses (dose reference: equivalent to prednisone 20 mg/day for more than one week); or monoclonal antibodies; or thymus peptide; or interferon, etc.; However, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are allowed; Lymphoproliferative disorders are not controlled.

6. Non-live vaccine = 14 days before vaccination and live attenuated vaccine 30 days before =vaccination.

7. Patients with malignant tumors who are undergoing chemotherapy, radiotherapy, immunotherapy, etc. before and after surgery, Patients in the state of organ transplantation.

8. Those suffering from uncontrolled epilepsy and other progressive neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.).

9. Patients with acute diseases, or acute exacerbations of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure = 160mmHg and/or diastolic blood pressure =100mmHg).

10. Lactating women or pregnant women; The investigator believes that the participant has any disease or condition that would put the participant at risk, the participant cannot complete the study as required by the protocol, and there are circumstances that interfere with the assessment of vaccine response.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Intervention

Biological:
• Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
Intramuscular injection of deltoid muscle of upper arm of 25µg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).
• Recombinant novel coronavirus protein vaccine (CHO cells)
Intramuscular injection of deltoid muscle of upper arm of 25µg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events after 2 doses given intramuscularly according to different immunization programs	The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection.	6 months after 2 doses of vaccine
Primary	Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs	Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.	14 days after 2 doses of vaccine
Primary	Immunogenic end points	Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.	14 days after 2 doses of vaccine
Secondary	Laboratory markers of immunity	Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (BA.4/5, BF.7) after 2 doses of vaccine candidate.	14 days after 2 doses of vaccine
Secondary	Laboratory markers of immunity	Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (BA.4/5, BF.7) after 2 doses of investigational vaccine.	14 days after 2 doses of vaccine
Secondary	Immunogenic end points	Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine.	14 days after 2 doses of vaccine
Secondary	Laboratory markers of immunity	Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine.	14 days after 2 doses of vaccine
Secondary	Laboratory markers of immunity	Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (XBB, BA.4/5, BF.7) after 2 doses of vaccine candidate.	6 months after 2 doses of vaccine
Secondary	Laboratory markers of immunity	Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of investigational vaccine.	6 months after 2 doses of vaccine
Secondary	Immunogenic end points	Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine.	6 months after 2 doses of vaccine