Prevention of COVID-19Phase 1/2NCT05198063
ZF2001 Booster Immunization Clinical Trials of 6 Months After the Completion of Basic Immunization
A Phase 1/2 study testing Recombinant novel coronavirus vaccine (CHO cells) in people with Prevention of COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of the recombinant novel coronavirus vaccine (CHO cells) after the booster immunization. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells)… 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
- What is being tested?
- Recombinant novel coronavirus vaccine (CHO cells)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2022to 6 Dec 2022
- Phase
- Phase 1/2
- 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
- Subjects of 18 years old and above who has completed basic immunization with recombinant novel coronavirus vaccine (CHO cells) since 6 months (window period ± 1 month);
- The subjects voluntarily participate in the study, sign an informed consent form, and can provide valid identification, understand and comply with the requirements of the trial protocol;
- Female subjects of childbearing age agree to take effective contraceptive measures from the start of the study to 1 month after vaccination.
Who cannot join
- A confirmed case of novel coronavirus infection or asymptomatic infection or a history of positive novel coronavirus nucleic acid test;
- Patients with uncontrolled lymphoproliferative diseases, unresolved aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled coagulopathy, etc;
- Patients with malignant tumors before and after surgery, patients undergoing chemotherapy, radiotherapy, immunotherapy, etc.; patients with organ transplantation status;
- People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
- Suffering from acute diseases, or acute attacks of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg);
- Previous history of severe allergies to any vaccine, or history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, vascular nerve Sexual edema, etc;
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- Women who are breastfeeding or pregnant;
- In addition to completing the recombinant novel coronavirus vaccine (CHO cell) within the past 7 months, has participated or is participating in other COVID-19 related clinical trials;
- Investigators believe that any disease or condition may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; the situation that interferes with the assessment of the vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention Preventive Medicine Clinic
Changsha, Hunan, 410005
About this study
Official title: To Evaluate the Immunogenicity and Safety of Booster Immunization 6 Months After the Completion of Basic Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cell) in People 18 Years Old and Above
The purpose of this study is to evaluate the immunogenicity and safety of the recombinant novel coronavirus vaccine (CHO cells) after the booster immunization. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 6 months (window period ± 1 month) after the basic immunization. Investigate the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination; the incidence of all AEs within 1 month after the booster vaccination, the incidence of all serious adverse events (SAE) within 6 months after the booster vaccination.
Read the detailed description
This study adopts an open experimental design. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 6 months (window period ± 1 month) after the basic immunization.
Immunogenicity observation: the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination.
Safety observation:
- All adverse events (AE) were collected within 30 minutes after the booster immunization, all AEs (including both solicited and unsolicited AEs) 0-7 days after the booster immunization, and all AEs (unsolicited AEs) 8-30 days after the booster immunization. Solicited AE (the following events occurring within 7 days of vaccination) : Adverse events at the inoculation site (local) : pain, pruritus, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reactions, cough.
- All SAEs were collected within 6 months after the booster immunization.
- Conditions
- Prevention of COVID-19
- Being tested
- Recombinant novel coronavirus vaccine (CHO cells)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant novel coronavirus vaccine (CHO cells)Biological
At 6 months after the basic immunization (window period ± 1 month), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated.
| Study group | Role | What they receive |
|---|---|---|
| Investigational vaccine group | Experimental | Recombinant novel coronavirus vaccine (CHO cells) injection, Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose. Receives: Biological: Recombinant novel coronavirus vaccine (CHO cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity endpoint
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Measured: 14 days after booster vaccination
Immunogenicity endpoint
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Measured: 30 days after booster vaccination
Immunogenicity endpoint
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Measured: 6 months after booster vaccination
Secondary outcomes (3)
Immunogenicity endpoint
GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Measured: 14 days, 30 days, and 6 months after booster vaccination
Safety endpoint
Incidence of all AEs
Measured: Within 1 month after booster vaccination
Safety endpoint
Incidence of all SAEs
Measured: Within 6 months after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start10 Jan 2022
- Primary completion31 Aug 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Huang, Bachelor, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198063
- Sponsor's protocol ID
- LKM-2021-NCV-JQ01
- Status last verified
- Jun 2023
- First submitted
- 4 Jan 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Immunogenicity and Safety of Booster Immunization 6 Months After the Completion of Basic Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cell) in People 18 Years Old and Above
- ClinicalTrials.gov ID
- NCT05198063
- Acronym / sponsor ID
- LKM-2021-NCV-JQ01
- Conditions
- Prevention of COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 20 Jan 2022 (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.
The purpose of this study is to evaluate the immunogenicity and safety of the recombinant novel coronavirus vaccine (CHO cells) after the booster immunization. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 6 months (window period ± 1 month) after the basic immunization. Investigate the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination; the incidence of all AEs within 1 month after the booster vaccination, the incidence of all serious adverse events (SAE) within 6 months after the booster vaccination.
Detailed description
This study adopts an open experimental design. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 6 months (window period ± 1 month) after the basic immunization.
Immunogenicity observation: the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination.
Safety observation:
- All adverse events (AE) were collected within 30 minutes after the booster immunization, all AEs (including both solicited and unsolicited AEs) 0-7 days after the booster immunization, and all AEs (unsolicited AEs) 8-30 days after the booster immunization. Solicited AE (the following events occurring within 7 days of vaccination) : Adverse events at the inoculation site (local) : pain, pruritus, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reactions, cough.
- All SAEs were collected within 6 months after the booster immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational vaccine group | Experimental | Biological: Recombinant novel coronavirus vaccine (CHO cells)Recombinant novel coronavirus vaccine (CHO cells) injection, Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of 18 years old and above who has completed basic immunization with recombinant novel coronavirus vaccine (CHO cells) since 6 months (window period ± 1 month);
- The subjects voluntarily participate in the study, sign an informed consent form, and can provide valid identification, understand and comply with the requirements of the trial protocol;
- Female subjects of childbearing age agree to take effective contraceptive measures from the start of the study to 1 month after vaccination.
Key exclusion criteria (9 listed)
- A confirmed case of novel coronavirus infection or asymptomatic infection or a history of positive novel coronavirus nucleic acid test;
- Patients with uncontrolled lymphoproliferative diseases, unresolved aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled coagulopathy, etc;
- Patients with malignant tumors before and after surgery, patients undergoing chemotherapy, radiotherapy, immunotherapy, etc.; patients with organ transplantation status;
- People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
- Suffering from acute diseases, or acute attacks of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg);
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 novel coronavirus vaccine (CHO cells)At 6 months after the basic immunization (window period ± 1 month), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated. | Biological | Investigational vaccine group |
Primary outcome
Immunogenicity endpoint
Time frame: 14 days after booster vaccination
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Immunogenicity endpoint
Time frame: 30 days after booster vaccination
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Immunogenicity endpoint
Time frame: 6 months after booster vaccination
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
3 secondary outcomes
Immunogenicity endpoint
Time frame: 14 days, 30 days, and 6 months after booster vaccination
Safety endpoint
Time frame: Within 1 month after booster vaccination
Safety endpoint
Time frame: Within 6 months after booster vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Tao Huang, Bachelor principal investigator
Hunan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant novel coronavirus vaccine (CHO cells) in people with Prevention of COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
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 9 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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunogenicity endpoint (time frame: 14 days after booster 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?
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 15 Jun 2023.