NCT04646590

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28,904 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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) .

Conditions

• Prevention of COVID-19
• Safety and Efficacy

Interventions

Type	Name	Description
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).
BIOLOGICAL	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.

Timeline

• Start date: 2020-12-16
• Primary completion: 2021-11-28
• Completion: 2022-12-01
• First posted: 2020-11-30
• Last updated: 2022-01-19

Locations

18 sites across 5 countries: China, Ecuador, Indonesia, Pakistan, Uzbekistan