COVID-19Phase 4NCT05890521
Safety Study of COVID19 Vaccine on the Market
A Phase 4 study testing Recombinant new coronavirus vaccine (CHO cell) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic:Multi-center safety observation of recombinant Novel Coronavirus protein vaccine (CHO cells) in a large population Study population:People aged 18 and above Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant new coronavirus vaccine (CHO cell)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2022to Jun 2023
- Phase
- Phase 4
- 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
- Healthy people or special people aged 18 and above who meet the requirements of national new coronavirus vaccination (including but not limited to obesity (BMI ≥ 28kg/ m²). Chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc.); If the researcher determines that it is necessary, the special population shall provide relevant written diagnosis certificates, records or drug prescription certificates issued by doctors;
- The subjects voluntarily participated in the study, signed the informed consent, understood and complied with the requirements of the clinical trial scheme, and were able to understand the research procedures.
Who cannot join
- Patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled bleeding and coagulation diseases, etc;
- People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
- Patients suffering from acute disease, or acute attack of chronic disease, or uncontrolled severe chronic disease;
- Previous history of severe allergy to any vaccine or any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, Henoch Schonlein purpura, thrombocytopenic purpura, dyspnea, angioneuroedema, etc;
- The researchers believe that the subject has any disease or condition that may put the subject at unacceptable risk; The subjects could not meet the protocol requirements; Interference with the evaluation of vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 411228
Lidong Gao, 0731-84305911
About this study
Official title: Multi-center Safety Observation of COVID19 Vaccine in a Large Population
Popular topic:Multi-center safety observation of recombinant Novel Coronavirus protein vaccine (CHO cells) in a large population Study population:People aged 18 and above
Read the detailed description
Overall design:The aim of this study is to carry out safety studies in the large scale healthy population and special population of recombinant New Coronavirus protein vaccine (CHO cell) in China. It will be included in 100 thousand subjects, including 20 thousand special populations. It is planned to enroll 50000 cases in Hunan (including no less than 10000 special people), 40000 cases in Guizhou (including no less than 8000 special people), and 10000 cases in Hainan (including no less than 2000 special people).
Special groups include but are not limited to obesity, chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc. If the researcher determines that it is necessary, the special population shall provide the medical diagnosis certificate or the drug prescription certificate issued by the doctor.
Immunization program: Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person.
Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.
Follow up and record:
- Passive monitoring: After all subjects have been vaccinated, the researcher shall conduct safety education and issue contact cards to the subjects, so that the subjects can contact the researcher in time in case of any discomfort. The researcher shall timely standardize the treatment and collect the AESI or SAE information of the subjects.
- Active monitoring:
All subjects installed customized APP or Wechat applet through mobile phones on the first 7 days and 30 days after each dose of vaccination, and 3, 6, 9 and 12 months after the last dose of vaccination, and recorded and collected the occurrence of adverse events: ① the first dose of vaccination - 30 days after the whole dose of vaccination, and 30 days after the enhanced vaccination, including the occurrence of all adverse events, including solicited AE (vaccination site (local adverse events) Non inoculated sites (systemic adverse events)) and non solicited AEs; ② First dose - SAE, AESI and pregnancy events within 12 months after full vaccination and 12 months after booster immunization.
The solicitation AE is:
Adverse events at the inoculation site (local): pain, pruritus, erythema, swelling, rash and induration; Non inoculated site (systemic) adverse events: fever, headache, fatigue / fatigue, diarrhea, nausea, vomiting, muscle pain (non inoculated site), acute allergic reaction and cough.
Safety assessment:
AE, AESI and SAE:
- Collect adverse events of special concern (AESI) from the first dose of vaccination to one year after the whole course of vaccination and one year after intensive immunization, including myocarditis / pericarditis, thrombosis, thrombocytopenia, immune related diseases (psoriasis, rheumatoid arthritis, etc.), nervous system related diseases (glibali syndrome, peripheral neuropathy, bell facial paralysis);
- Collect serious adverse events (SAE) from the first dose of vaccination to 1 year after the whole course of vaccination and 1 year after intensive immunization;
- Collect all AEs from the first dose to 30 days after the whole course of vaccination and 30 days after booster immunization.
Pregnancy events:
The pregnancy events from the first dose of vaccination to one year after the whole course of vaccination and one year after the booster vaccination were collected (at the same time, the safety and pregnancy outcome of pregnant women's accidental vaccination were analyzed).
ADE/ VED risk monitoring:
After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with SARS-COV-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. For confirmed cases, detailed case investigation shall be carried out. In case of aggregated new coronavirus infection or severe, critical and death cases after sars-cov-2 infection during the trial, special investigation shall be carried out. According to the analysis of special investigation results, if there is ADE/ VED phenomenon, an expert meeting shall be held to evaluate whether there is ADE / VED risk.
- Conditions
- COVID-19
- Being tested
- Recombinant new coronavirus vaccine (CHO cell)
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Medical subject headings
- COVID-19
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)Biological
Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person.
Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.
| Study group | Role | What they receive |
|---|---|---|
| Population Ⅰ | Experimental | Not described Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAE
Serious adverse events (SAE) were collected from the first dose to 1 year after full vaccination and 1 year after booster immunization.
Measured: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
AE
All AE from the first dose to 30 days after full vaccination and 30 days after booster immunization were collected.
Measured: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
AESI
Adverse events of special Interest (AESI) analysis 12 months after first dose-full dose and 12 months after booster dose: incidence of adverse events of special interest
Measured: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Secondary outcomes (1)
ADE/VED
After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with sars-cov-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. For confirmed cases, detailed case investigation shall be carried out. In case of aggregated new coronavirus infection or severe, critical and death cases after sars-cov-2 infection during the trial, special investigation shall be carried out. According to the analysis of special investigation results, if there is ADE / VED phenomenon, an expert meeting shall be held to evaluate whether there is ADD/ VED risk.
Measured: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start2 Apr 2022
- Primary completion16 Jun 2022
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person. Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Hainan Center for Disease Control & Prevention
- Responsible party
- Sponsor
- Investigators
- Lidong Gao, Study chair, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890521
- Sponsor's protocol ID
- LKM-2022-NCV-PM01
- Status last verified
- Jun 2023
- First submitted
- 28 Mar 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Safety Observation of COVID19 Vaccine in a Large Population
- ClinicalTrials.gov ID
- NCT05890521
- Acronym / sponsor ID
- LKM-2022-NCV-PM01
- Conditions
- COVID-19
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Hainan Center for Disease Control & Prevention
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 Jun 2023 (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.
Popular topic:Multi-center safety observation of recombinant Novel Coronavirus protein vaccine (CHO cells) in a large population Study population:People aged 18 and above
Detailed description
Overall design:The aim of this study is to carry out safety studies in the large scale healthy population and special population of recombinant New Coronavirus protein vaccine (CHO cell) in China. It will be included in 100 thousand subjects, including 20 thousand special populations. It is planned to enroll 50000 cases in Hunan (including no less than 10000 special people), 40000 cases in Guizhou (including no less than 8000 special people), and 10000 cases in Hainan (including no less than 2000 special people).
Special groups include but are not limited to obesity, chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc. If the researcher determines that it is necessary, the special population shall provide the medical diagnosis certificate or the drug prescription certificate issued by the doctor.
Immunization program: Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person.
Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.
Follow up and record:
- Passive monitoring: After all subjects have been vaccinated, the researcher shall conduct safety education and issue contact cards to the subjects, so that the subjects can contact the researcher in time in case of any discomfort. The researcher shall timely standardize the treatment and collect the AESI or SAE information of the subjects.
- Active monitoring:
All subjects installed customized APP or Wechat applet through mobile phones on the first 7 days and 30 days after each dose of vaccination, and 3, 6, 9 and 12 months after the last dose of vaccination, and recorded and collected the occurrence of adverse events: ① the first dose of vaccination - 30 days after the whole dose of vaccination, and 30 days after the enhanced vaccination, including the occurrence of all adverse events, including solicited AE (vaccination site (local adverse events) Non inoculated sites (systemic adverse events)) and non solicited AEs; ② First dose - SAE, AESI and pregnancy events within 12 months after full vaccination and 12 months after booster immunization.
The solicitation AE is:
Adverse events at the inoculation site (local): pain, pruritus, erythema, swelling, rash and induration; Non inoculated site (systemic) adverse events: fever, headache, fatigue / fatigue, diarrhea, nausea, vomiting, muscle pain (non inoculated site), acute allergic reaction and cough.
Safety assessment:
AE, AESI and SAE:
- Collect adverse events of special concern (AESI) from the first dose of vaccination to one year after the whole course of vaccination and one year after intensive immunization, including myocarditis / pericarditis, thrombosis, thrombocytopenia, immune related diseases (psoriasis, rheumatoid arthritis, etc.), nervous system related diseases (glibali syndrome, peripheral neuropathy, bell facial paralysis);
- Collect serious adverse events (SAE) from the first dose of vaccination to 1 year after the whole course of vaccination and 1 year after intensive immunization;
- Collect all AEs from the first dose to 30 days after the whole course of vaccination and 30 days after booster immunization.
Pregnancy events:
The pregnancy events from the first dose of vaccination to one year after the whole course of vaccination and one year after the booster vaccination were collected (at the same time, the safety and pregnancy outcome of pregnant women's accidental vaccination were analyzed).
ADE/ VED risk monitoring:
After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with SARS-COV-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. For confirmed cases, detailed case investigation shall be carried out. In case of aggregated new coronavirus infection or severe, critical and death cases after sars-cov-2 infection during the trial, special investigation shall be carried out. According to the analysis of special investigation results, if there is ADE/ VED phenomenon, an expert meeting shall be held to evaluate whether there is ADE / VED risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person. Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.
| Arm | Type | Receives |
|---|---|---|
| Population Ⅰ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy people or special people aged 18 and above who meet the requirements of national new coronavirus vaccination (including but not limited to obesity (BMI ≥ 28kg/ m²). Chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc.); If the researcher determines that it is necessary, the special population shall provide relevant written diagnosis certificates, records or drug prescription certificates issued by doctors;
- The subjects voluntarily participated in the study, signed the informed consent, understood and complied with the requirements of the clinical trial scheme, and were able to understand the research procedures.
Key exclusion criteria (5 listed)
- Patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled bleeding and coagulation diseases, etc;
- People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
- Patients suffering from acute disease, or acute attack of chronic disease, or uncontrolled severe chronic disease;
- Previous history of severe allergy to any vaccine or any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, Henoch Schonlein purpura, thrombocytopenic purpura, dyspnea, angioneuroedema, etc;
- The researchers believe that the subject has any disease or condition that may put the subject at unacceptable risk; The subjects could not meet the protocol requirements; Interference with the evaluation of vaccine response.
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)Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person. Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person. | Biological | Population Ⅰ |
Primary outcome
SAE
Time frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Serious adverse events (SAE) were collected from the first dose to 1 year after full vaccination and 1 year after booster immunization.
AE
Time frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
All AE from the first dose to 30 days after full vaccination and 30 days after booster immunization were collected.
AESI
Time frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Adverse events of special Interest (AESI) analysis 12 months after first dose-full dose and 12 months after booster dose: incidence of adverse events of special interest
1 secondary outcome
ADE/VED
Time frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Lidong Gao study chair
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 4 study testing Recombinant new coronavirus vaccine (CHO cell) in people with 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 2 inclusion and 5 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 6 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Lidong Gao (0731-84305911, 810173358@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAE (time frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose). 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 6 Jun 2023.