A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19
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ClinicalTrials.gov Identifier: NCT04646590 |
Recruitment Status :
Active, not recruiting
First Posted : November 30, 2020
Last Update Posted : January 19, 2022
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Condition or disease | Intervention/treatment | Phase |
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Prevention of COVID-19 Safety and Efficacy | Biological: Recombinant new coronavirus vaccine (CHO cell) group Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group | Phase 3 |
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) .
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28904 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | December 16, 2020 |
Actual Primary Completion Date : | November 28, 2021 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: Investigational Vaccine
Recombinant Novel Coronavirus Vaccine (CHO cell), 0.5mL/vial, contains 25 μg NCP-RBD protein. After mixing, take all the liquid and inject intramuscularly into deltoid muscle of upper arm.
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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). |
Placebo Comparator: Placebo comparator
Placebo for Recombinant Novel Coronavirus Vaccine (CHO cell), 0.5mL/vial, contains 0.25mg Aluminum hydroxide adjuvant. After mixing, take all the liquid and inject intramuscularly into deltoid muscle of upper arm.
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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. |
- The endpoint of efficacy study [ Time Frame: 14 days to one year after whole vaccination ]The number of any severity of COVID-9 cases 14 days after whole vaccination
- The endpoint of safety study [ Time Frame: From the first dose of vaccination until 30 days after full course of vaccination ]Analysis of adverse events from the first dose of vaccination until 30 days after full course of vaccination
- The endpoint of safety study [ Time Frame: From the first dose of vaccination until 12 months after full course of vaccination ]Analysis of serious adverse events from the first dose of vaccination until 12 months after full course of vaccination
- The endpoint of efficacy study [ Time Frame: Up to one year after the vaccination ]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.
- Endpoint of immunogenicity and immune persistence study [ Time Frame: At 14 days and 6 months after full course of vaccination ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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;
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Those who are suffering from the following diseases:
- With thrombocytopenia, any coagulation dysfunction or receiving anti-coagulatory treatment
- 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;
- 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.);
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646590

Principal Investigator: | Fangjun Li, Bachelor | Hunan Provincial Center for Disease Control and Prevention |
Responsible Party: | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04646590 |
Other Study ID Numbers: |
LKM-2020-NCV-GJ01 |
First Posted: | November 30, 2020 Key Record Dates |
Last Update Posted: | January 19, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Vaccines Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Immunologic Factors Physiological Effects of Drugs |