Prevention of COVID-19Phase 3NCT04646590
A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19
A Phase 3 study testing Recombinant new coronavirus vaccine (CHO cell) group in people with Prevention of COVID-19 and Safety and Efficacy, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 18 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of COVID-19, Safety and Efficacy
- What is being tested?
- Recombinant new coronavirus vaccine (CHO cell) group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28,904 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 16 Dec 2020to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Pakistan8 sites
Aziz Fatimah Hospital
Faisalabad, Punjab Province
Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad
Indus Hospital and Health Network
Karachi, Sindh
Avicenna Hospital
Lahore, Punjab Province
Central Park Teaching Hospital
Lahore, Punjab Province
National Hospital & Medical Center
Lahore, Punjab Province
University of Health Sciences
Lahore, Punjab Province
Al-Shifa Trust Eye Hospital
Rawalpindi, Punjab Province
Uzbekistan4 sites
Family Hospital No.15
Tashkent
GUVD Poliklinika
Tashkent
IIV Markaziy Poliklinika
Tashkent
Toshkent viloyat IIV Poliklinika
Tashkent
Ecuador3 sites
Biodimed Guayaquil Clinical Research Center
Guayaquil, Guayas
Biodimed Alemania Clinical Research Center
Quito, Pichincha
Biodimed Eloy Alfaro Clinical Research Center
Quito, Pichincha
Indonesia2 sites
FK Unpad/RSHS
Bandung, West Java
Fkui-Rscm
Jakarta, Jakarta Special Capital Region
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
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
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.
Read the 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
- Being tested
- Recombinant new coronavirus vaccine (CHO cell) group, Recombinant new coronavirus vaccine (CHO cells) placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant new coronavirus vaccine (CHO cell) groupBiological
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 groupBiological
Intramuscular injection of deltoid muscle of upper arm of 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endpoint of efficacy study
The number of any severity of COVID-9 cases 14 days after whole vaccination
Measured: 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
Measured: 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
Measured: From the first dose of vaccination until 12 months after full course of vaccination
Secondary outcomes (2)
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.
Measured: Up to one year after the 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.
Measured: At 14 days and 6 months after full course of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start16 Dec 2020
- Primary completion28 Nov 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28,904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fangjun Li, Bachelor, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646590
- Sponsor's protocol ID
- LKM-2020-NCV-GJ01
- Status last verified
- Jan 2022
- First submitted
- 25 Nov 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35507481
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04646590
- Acronym / sponsor ID
- LKM-2020-NCV-GJ01
- Conditions
- Prevention of COVID-19, Safety and Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28,904 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Vaccine | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) groupRecombinant 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 comparator | Placebo comparator | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo groupPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant new coronavirus vaccine (CHO cell) groupIntramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Investigational Vaccine |
| Recombinant new coronavirus vaccine (CHO cells) placebo groupIntramuscular injection of deltoid muscle of upper arm of 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo. | Biological | Placebo comparator |
Primary outcome
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
2 secondary outcomes
The endpoint of efficacy study
Time frame: Up to one year after the vaccination
Endpoint of immunogenicity and immune persistence study
Time frame: At 14 days and 6 months after full course of vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 35507481Dai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fangjun Li, Bachelor principal investigator
Hunan Provincial Center for Disease Control and Prevention
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant new coronavirus vaccine (CHO cell) group in people with Prevention of COVID-19 and Safety and Efficacy, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Pakistan, Uzbekistan, Ecuador, Indonesia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endpoint of efficacy study (time frame: 14 days to one year after whole vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.