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

NCT04646590 | Unknown Phase 3 DMC

• 1 other identifier: LKM-2020-NCV-GJ01
• Study Type: interventional
• Target: 28,904
• Locations: 5 countries
• Sites: 18

Brief 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.

Conditions

Prevention of COVID-19; Safety and Efficacy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• The endpoint of efficacy study

  Up to one year after the vaccination

• Endpoint of immunogenicity and immune persistence study

  At 14 days and 6 months after full course of vaccination

Study Arms (2)

Investigational Vaccine

EXPERIMENTAL

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.

Biological: Recombinant new coronavirus vaccine (CHO cell) group

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.

Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group

Interventions

Recombinant new coronavirus vaccine (CHO cell) group BIOLOGICAL

Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Investigational Vaccine

Recombinant new coronavirus vaccine (CHO cells) placebo group BIOLOGICAL

Intramuscular injection of deltoid muscle of upper arm of 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.

Placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (18)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 410005, China

Location

Biodimed Guayaquil Clinical Research Center

Guayaquil, Guayas, Ecuador

Location

Biodimed Alemania Clinical Research Center

Quito, Pichincha, Ecuador

Location

Biodimed Eloy Alfaro Clinical Research Center

Quito, Pichincha, Ecuador

Location

Fkui-Rscm

Jakarta, Jakarta Special Capital Region, Indonesia

Location

FK Unpad/RSHS

Bandung, West Java, Indonesia

Location

Aziz Fatimah Hospital

Faisalabad, Punjab Province, Pakistan

Location

Avicenna Hospital

Lahore, Punjab Province, Pakistan

Location

Central Park Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

National Hospital & Medical Center

Lahore, Punjab Province, Pakistan

Location

University of Health Sciences

Lahore, Punjab Province, Pakistan

Location

Al-Shifa Trust Eye Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Indus Hospital and Health Network

Karachi, Sindh, Pakistan

Location

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

Location

Family Hospital No.15

Tashkent, Uzbekistan

Location

GUVD Poliklinika

Tashkent, Uzbekistan

Location

IIV Markaziy Poliklinika

Tashkent, Uzbekistan

Location

Toshkent viloyat IIV Poliklinika

Tashkent, Uzbekistan

Location

Related Publications (1)

• Dai L, Gao L, Tao L, Hadinegoro SR, Erkin M, Ying Z, He P, Girsang RT, Vergara H, Akram J, Satari HI, Khaliq T, Sughra U, Celi AP, Li F, Li Y, Jiang Z, Dalimova D, Tuychiev J, Turdikulova S, Ikram A, Flores Lastra N, Ding F, Suhardono M, Fadlyana E, Yan J, Hu Z, Li C, Abdurakhmonov IY, Gao GF; ZF2001 Global Trial Group. Efficacy and Safety of the RBD-Dimer-Based Covid-19 Vaccine ZF2001 in Adults. N Engl J Med. 2022 Jun 2;386(22):2097-2111. doi: 10.1056/NEJMoa2202261. Epub 2022 May 4.

  PMID: 35507481 DERIVED

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Fangjun Li, Bachelor

  Hunan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: November 30, 2020
• Study Start: December 16, 2020
• Primary Completion: November 28, 2021
• Study Completion: December 1, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

UZ (4); EC (3); PA (8); ID (2); CN (1)