COVID-19NCT05895110
To Evaluate the Immunogenicity and Safety of Sequential Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) for SARS-CoV-2
A study testing Recombinant Novel Coronavirus vaccine (CHO Cells) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
An open experimental design was used in this study, and 240 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential intensification in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant Novel Coronavirus vaccine (CHO Cells)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2022to 19 Nov 2022
- Phase
- Interventional
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy subjects aged 3 to 17 years who can provide vaccination information proving that they have received two doses of commercially available Novel Coronavirus inactivated vaccine in the last 6-9 months;
- The subject voluntarily agrees to participate in the study (and/or the subject's legal guardian voluntarily agrees to allow the child to participate in the study), and the guardian and the subject (aged 8-17) sign the informed consent, and can provide valid identification; Understand and comply with test protocol requirements;
- Armpit temperature \< 37.3℃ (> 14 years old), armpit temperature \< 37.5℃ (≤14 years old);
- Female subjects of reproductive age agree to use effective contraceptive measures from the beginning to the end of the study.
Who cannot join
- History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection;
- SARS virus disease history or SARS-COV-2 history;
- Have taken antipyretics or painkillers within 24 hours before vaccination;
- Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angiopantic edema, etc.;
- Persons suffering from the following diseases:
- In the past 7 days, have suffered from digestive diseases (such as diarrhea, abdominal pain, vomiting, etc.);
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- congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;
- Neurological disorders or neurodysplasia (e.g., migraines, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history;
- History of congenital or acquired immune deficiency or autoimmune disease or treatment with immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed;
- Known to have been diagnosed with an infectious disease, such as active tuberculosis, viral hepatitis or treponema pallidum;
- Subunit vaccine and inactivated vaccine should be administered within 14 days before experimental vaccine, and live attenuated vaccine should be administered within 30 days before experimental vaccine;
- Have received blood or blood-related products, including immunoglobulin, within 3 months prior to the trial vaccine; Or planned for use during the study period;
- People aged 3-17 years who have participated in or are participating in other COVID-19 related clinical trials or have received other COVID-19 vaccines, except those who have completed two doses of marketed Novel Coronavirus inactivated vaccine within 6-9 months;
- Pregnant (including positive urine pregnancy), or breast-feeding; The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
Official title: To Evaluate the Immunogenicity and Safety of Sequentially Enhanced Recombinant Novel Coronavirus Vaccine (CHO Cells) in Patients Aged 3-17 Years After Completion of Two Doses of Novel Coronavirus Inactivated Vaccine
An open experimental design was used in this study, and 240 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential intensification in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
Read the detailed description
One dose of recombinant novel coronavirus vaccine (CHO cell) for test was injected into the upper arm deltoid muscle muscle of the subject
- Conditions
- COVID-19
- Being tested
- Recombinant Novel Coronavirus vaccine (CHO Cells)
- Keywords
- COVID-19 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 Novel Coronavirus vaccine (CHO Cells)Biological
The experimental vaccine dose used in this study is 25μg/0.5mL. All subjects recruited should have received two doses of novel Coronavirus inactivated vaccine on the market for 6-9 months, and all eligible subjects will receive one dose of recombinant Novel Coronavirus vaccine (CHO cells).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1 dose of the test recombinant novel coronavirus vaccine (CHO cell) was injected into the deltoid muscle of the subject's upper arm 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.
SARS-COV-2 neutralizing antibody
Titers of SARS-COV-2 neutralizing Antibody at 14 days and 6 months after vaccination of recombinant Novel Coronavirus vaccine (CHO cells) (GMT)
Measured: 14 days and 6 months after inoculation
Secondary outcomes (1)
SARS-COV-2 neutralizing antibody
GMI and 4-fold increase in SARS-COV-2 neutralizing antibody at 14 days and 6 months after intensification of recombinant Novel Coronavirus vaccine (CHO cells)
Measured: 14 days and 6 months after inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start29 Apr 2022
- Primary completion19 Nov 2022
- Study completion19 Nov 2022
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895110
- Sponsor's protocol ID
- LKM-2022-NCV-JQ01
- Status last verified
- Jun 2023
- First submitted
- 22 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang T, Hu Q, Zhou X, Yang H, Xia W, Cao F, Deng M, Teng X, Ding F, Zhong Z, Gao L, Sun J, Gong L. Immunogenicity and safety of a recombinant COVID-19 vaccine (ZF2001) as heterologous booster after priming with inactivated vaccine in healthy children and adolescents aged 3-17 years: an open-labeled, single-arm clinical trial. BMC Infect Dis. 2024 Apr 19;24(1):413. doi: 10.1186/s12879-024-09293-1.
PubMed 38641791
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Immunogenicity and Safety of Sequentially Enhanced Recombinant Novel Coronavirus Vaccine (CHO Cells) in Patients Aged 3-17 Years After Completion of Two Doses of Novel Coronavirus Inactivated Vaccine
- ClinicalTrials.gov ID
- NCT05895110
- Acronym / sponsor ID
- LKM-2022-NCV-JQ01
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 19 Nov 2022 (actual)
- First posted
- 8 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.
An open experimental design was used in this study, and 240 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential intensification in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
Detailed description
One dose of recombinant novel coronavirus vaccine (CHO cell) for test was injected into the upper arm deltoid muscle muscle of the subject
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Recombinant Novel Coronavirus vaccine (CHO Cells)1 dose of the test recombinant novel coronavirus vaccine (CHO cell) was injected into the deltoid muscle of the subject's upper arm |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy subjects aged 3 to 17 years who can provide vaccination information proving that they have received two doses of commercially available Novel Coronavirus inactivated vaccine in the last 6-9 months;
- The subject voluntarily agrees to participate in the study (and/or the subject's legal guardian voluntarily agrees to allow the child to participate in the study), and the guardian and the subject (aged 8-17) sign the informed consent, and can provide valid identification; Understand and comply with test protocol requirements;
- Armpit temperature \< 37.3℃ (> 14 years old), armpit temperature \< 37.5℃ (≤14 years old);
- Female subjects of reproductive age agree to use effective contraceptive measures from the beginning to the end of the study.
Key exclusion criteria (15 listed)
- History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection;
- SARS virus disease history or SARS-COV-2 history;
- Have taken antipyretics or painkillers within 24 hours before vaccination;
- Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angiopantic edema, etc.;
- Persons 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 Novel Coronavirus vaccine (CHO Cells)The experimental vaccine dose used in this study is 25μg/0.5mL. All subjects recruited should have received two doses of novel Coronavirus inactivated vaccine on the market for 6-9 months, and all eligible subjects will receive one dose of recombinant Novel Coronavirus vaccine (CHO cells). | Biological | Experimental group |
Primary outcome
SARS-COV-2 neutralizing antibody
Time frame: 14 days and 6 months after inoculation
Titers of SARS-COV-2 neutralizing Antibody at 14 days and 6 months after vaccination of recombinant Novel Coronavirus vaccine (CHO cells) (GMT)
1 secondary outcome
SARS-COV-2 neutralizing antibody
Time frame: 14 days and 6 months after inoculation
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 8 Jun 2023.
- Derived from this study: PubMed 38641791Huang T, Hu Q, Zhou X, Yang H, Xia W, Cao F, Deng M, Teng X, Ding F, Zhong Z, Gao L, Sun J, Gong L. Immunogenicity and safety of a recombinant COVID-19 vaccine (ZF2001) as heterologous booster after priming with inactivated vaccine in healthy children and adolescents aged 3-17 years: an open-labeled, single-arm clinical trial. BMC Infect Dis. 2024 Apr 19;24(1):413. doi: 10.1186/s12879-024-09293-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Novel Coronavirus vaccine (CHO Cells) 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 4 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: finished, as of the sponsor's last update on 8 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.
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?
SARS-COV-2 neutralizing antibody (time frame: 14 days and 6 months after inoculation). 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 NCT05895110, 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 8 Jun 2023.