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

Primary Purpose

Prevention of COVID-19, Safety and Efficacy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Recombinant new coronavirus vaccine (CHO cell) group
Recombinant new coronavirus vaccine (CHO cells) placebo group
Sponsored by
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hunan Provincial Center for Disease Control and Prevention
  • Biodimed Guayaquil Clinical Research Center
  • Biodimed Alemania Clinical Research Center
  • Biodimed Eloy Alfaro Clinical Research Center
  • Fkui-Rscm
  • FK Unpad/RSHS
  • Aziz Fatimah Hospital
  • Avicenna Hospital
  • Central Park Teaching Hospital
  • National Hospital & Medical Center
  • University of Health Sciences
  • Al-Shifa Trust Eye Hospital
  • Indus Hospital and Health Network
  • Shaheed Zulfiqar Ali Bhutto Medical University
  • Family Hospital No.15
  • GUVD Poliklinika
  • IIV Markaziy Poliklinika
  • Toshkent viloyat IIV Poliklinika

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational Vaccine

Placebo comparator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The endpoint of efficacy study
The number of any severity of COVID-9 cases 14 days 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
The endpoint of safety study
Analysis of serious adverse events from the first dose of vaccination until 12 months after full course of vaccination

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 25, 2020
Last Updated
January 17, 2022
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04646590
Brief Title
A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
November 28, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of COVID-19, Safety and Efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28904 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Recombinant new coronavirus vaccine (CHO cell) group
Intervention Description
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intervention Type
Biological
Intervention Name(s)
Recombinant new coronavirus vaccine (CHO cells) placebo group
Intervention Description
Intramuscular injection of deltoid muscle of upper arm of 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.
Primary Outcome Measure Information:
Title
The endpoint of efficacy study
Description
The number of any severity of COVID-9 cases 14 days after whole vaccination
Time Frame
14 days to one year after whole vaccination
Title
The endpoint of safety study
Description
Analysis of adverse events from the first dose of vaccination until 30 days after full course of vaccination
Time Frame
From the first dose of vaccination until 30 days after full course of vaccination
Title
The endpoint of safety study
Description
Analysis of serious adverse events from the first dose of vaccination until 12 months after full course of vaccination
Time Frame
From the first dose of vaccination until 12 months after full course of vaccination
Secondary Outcome Measure Information:
Title
The endpoint of efficacy study
Description
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.
Time Frame
Up to one year after the vaccination
Title
Endpoint of immunogenicity and immune persistence study
Description
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.
Time Frame
At 14 days and 6 months after full course of vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangjun Li, Bachelor
Organizational Affiliation
Hunan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincial Center for Disease Control and Prevention
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Biodimed Guayaquil Clinical Research Center
City
Guayaquil
State/Province
Guayas
Country
Ecuador
Facility Name
Biodimed Alemania Clinical Research Center
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Biodimed Eloy Alfaro Clinical Research Center
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Fkui-Rscm
City
Jakarta
State/Province
Daerah Khusus Ibukota Jakarta
Country
Indonesia
Facility Name
FK Unpad/RSHS
City
Bandung
State/Province
Jawa Barat
Country
Indonesia
Facility Name
Aziz Fatimah Hospital
City
Faisalabad
State/Province
Punjab
Country
Pakistan
Facility Name
Avicenna Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Central Park Teaching Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
National Hospital & Medical Center
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
University of Health Sciences
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Al-Shifa Trust Eye Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Facility Name
Indus Hospital and Health Network
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Shaheed Zulfiqar Ali Bhutto Medical University
City
Islamabad
Country
Pakistan
Facility Name
Family Hospital No.15
City
Tashkent
Country
Uzbekistan
Facility Name
GUVD Poliklinika
City
Tashkent
Country
Uzbekistan
Facility Name
IIV Markaziy Poliklinika
City
Tashkent
Country
Uzbekistan
Facility Name
Toshkent viloyat IIV Poliklinika
City
Tashkent
Country
Uzbekistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35507481
Citation
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.
Results Reference
derived

Learn more about this trial

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

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