A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19

Safety and Efficacy Clinical Trial

Official title:

A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, a Recombinant Novel Coronavirus Vaccine (CHO Cell) for Prevention of COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04646590
• Other study ID #: LKM-2020-NCV-GJ01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 16, 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind, placebo-controlled international multicenter clinical trial design will be adopted. A total of 29,000 subjects aged 18 years and above are planned to be recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years and above in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years and above will be recruited outside China. Safety and immunogenicity will be evaluated among the Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among the subjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 and above from outside China and all subjects from China will be selected as the immunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2 neutralizing antibody and RBD protein binding antibody will be detected by blood sampling before vaccination, 14 days and 6 months after full course of vaccination to evaluate the immunogenicity and immune persistence.

Description:

After signing the informed consent form, the volunteers aged 18 years and above will receive the relevant examinations after an inquiry by investigator of the medical history (including COVID-19 history), recent medication(vaccine) history, allergy history and concomitant medications, and demographic data collection by the investigators, including physical examination (skin and mucous membranes, lymph nodes, head, neck, chest, abdomen, spine/limbs), novel Coronavirus (SARS-COV-2) nucleic acid test and antibody test, urine pregnancy (women of childbearing age) test, and vital signs (blood pressure, axillary/oral temperature, pulse) evaluation. Screening eligible subjects will be 1:1 randomly assigned to the experimental group and the placebo control group, and vaccinated as per the 0, 1, 2 month immunization schedule. All adverse events (AEs) up to 30 minutes after each dose of vaccination, all AEs from 0 to 7 days (including both solicited and unsolicited), and all AES from 8 to 30 days (unsolicited) will be collected; All serious adverse events (SAEs) will be collected from the first dose of vaccination to 12 months after the whole vaccination. The incidence rate and efficacy of any severity of COVID-9 of any severity 14 days after whole vaccination. Blood samples (5ml) will be collected before the first dose of vaccination and 14 days and 6 months after the whole course of vaccination to detect neutralizing antibody of SARS-COV-2 and protein binding antibody IgG of receptor binding region (RBD) .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28904
• Est. completion date: December 2022
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Population aged 18 years and above;
• Subjects voluntarily participate in the study and sign the informed consent form; and are able to provide valid identification, and understand and comply with the requirements of the trial protocol;
• Female subjects of childbearing age agree to use effective contraceptive measures from the beginning of the study to 2 months after full course of vaccination.

Exclusion Criteria:

• Suspected or confirmed as fever(axillary temperature =37.3°C / oral temperature =37.5°C) within 72 hours before the enrollment, or axillary temperature =37.3°C / oral temperature =37.5°C at the day of screening;
• Diastolic blood pressure = 100mmhg and / or systolic blood pressure = 150mmhg;
• Patients with previous history of a COVID-19;
• Detection of SARS-COV-2 nucleic acid or antibody is positive;
• Those who are suffering from the following diseases:

1. With thrombocytopenia, any coagulation dysfunction or receiving anti-coagulatory treatment

2. Congenital or acquired immune deficiency or autoimmune disease history; no spleen, or history of splenic surgery and trauma, or receiving immunomodulator treatment within 6 months, e.g., immunosuppressive dose of glucocorticoids (reference dose: equivalent to 20mg/ day of prednisone, over 1 week); Or monoclonal antibodies; Or thymosin; Or interferon etc.; However, topical application (such as ointment, eye drops, inhalers or nasal sprays) is permitted;

3. Symptoms related to acute respiratory tract infection (such as sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of breath, etc.);

4. Cancer patients (except basal cell carcinoma).

• With a history of serious allergy to any vaccine or any composition of Investigational product (including: aluminum preparations), such as allergic shock, allergic throat edema, allergic purpura, thrombocytopenic purpura, localized allergic necrosis reaction (Arthus reaction), dyspnea and angioneuroedema;
• Inoculated with subunit vaccine and inactivated vaccine within 14 days before the first dosing of investigational vaccine, or inoculated with attenuated live vaccine within 30 days;
• Previous receiving blood transfusion or blood relevant products (including immunoglobulin) within 3 months, or planning to receive such products from the starting of study to <6 months after the whole-course inoculation;
• Have participated in or are participating in other covid-19 related clinical trials;
• Women in breastfeeding period or in pregnant period (including women at childbearing age with positive result of urine pregnancy test);
• Considered by investigators as any disease or state possibly making the subject at unacceptable risk; not conforming to the requirements of study protocol; interference of assessment of reactions of vaccine.

Related Conditions & MeSH terms

• COVID-19
• Prevention of COVID-19
• Safety and Efficacy

Intervention

Biological:
• Recombinant new coronavirus vaccine (CHO cell) group
Intramuscular injection of deltoid muscle of upper armof 25µg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
• Recombinant new coronavirus vaccine (CHO cells) placebo group
Intramuscular injection of deltoid muscle of upper arm of 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.

Locations

Country	Name	City	State
China	Hunan Provincial Center for Disease Control and Prevention	Changsha	Hunan
Ecuador	Biodimed Guayaquil Clinical Research Center	Guayaquil	Guayas
Ecuador	Biodimed Alemania Clinical Research Center	Quito	Pichincha
Ecuador	Biodimed Eloy Alfaro Clinical Research Center	Quito	Pichincha
Indonesia	FK Unpad/RSHS	Bandung	Jawa Barat
Indonesia	Fkui-Rscm	Jakarta	Daerah Khusus Ibukota Jakarta
Pakistan	Aziz Fatimah Hospital	Faisalabad	Punjab
Pakistan	Shaheed Zulfiqar Ali Bhutto Medical University	Islamabad
Pakistan	Indus Hospital and Health Network	Karachi	Sindh
Pakistan	Avicenna Hospital	Lahore	Punjab
Pakistan	Central Park Teaching Hospital	Lahore	Punjab
Pakistan	National Hospital & Medical Center	Lahore	Punjab
Pakistan	University of Health Sciences	Lahore	Punjab
Pakistan	Al-Shifa Trust Eye Hospital	Rawalpindi	Punjab
Uzbekistan	Family Hospital No.15	Tashkent
Uzbekistan	GUVD Poliklinika	Tashkent
Uzbekistan	IIV Markaziy Poliklinika	Tashkent
Uzbekistan	Toshkent viloyat IIV Poliklinika	Tashkent

Sponsors (1)

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

Countries where clinical trial is conducted

China,  Ecuador,  Indonesia,  Pakistan,  Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The endpoint of efficacy study	The number of any severity of COVID-9 cases 14 days after whole vaccination	14 days to one year after whole vaccination
Primary	The endpoint of safety study	Analysis of adverse events from the first dose of vaccination until 30 days after full course of vaccination	From the first dose of vaccination until 30 days after full course of vaccination
Primary	The endpoint of safety study	Analysis of serious adverse events from the first dose of vaccination until 12 months after full course of vaccination	From the first dose of vaccination until 12 months after full course of vaccination
Secondary	The endpoint of efficacy study	The number of severe and severity above COVID-19 cases 14 days after whole vaccination; The number of any severity of COVID-9 cases after first dose of vaccination; The number of COVID-19 cases of any severity in populations of different age group (18-59 years vs. 60 years and above) 14 days after whole vaccination.	Up to one year after the vaccination
Secondary	Endpoint of immunogenicity and immune persistence study	The level of neutralizing antibody to SARS-COV-2 and IgG level of RBD protein binding antibody at 14 days and 6 months after full course of vaccination.	At 14 days and 6 months after full course of vaccination