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

Launched by ANHUI ZHIFEI LONGCOM BIOLOGIC PHARMACY CO., LTD. · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine designed to protect against COVID-19, specifically targeting the Omicron BA.4/5 and Delta variants. The main goal is to see how well this vaccine works and how safe it is for adults aged 18 and older after receiving two doses. Researchers will also look at how long the immune response lasts after vaccination. The study involves 160 participants, including 80 older adults, and follows a randomized and double-blind approach, which means neither the participants nor the researchers know who receives the vaccine or a placebo until the study is finished.

To be eligible for this trial, participants must be at least 18 years old and should have received their last COVID-19 vaccine more than six months before joining the study. They should not have any severe allergies to vaccines or have certain health conditions that could complicate the study. Those who join can expect to receive two doses of the vaccine, and their health and immune response will be closely monitored. It's important to note that the trial is not currently recruiting participants, so interested individuals will need to wait until it is open for enrollment.

Gender

ALL

Eligibility criteria

• 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.