Coronavirus Disease 2019Phase 3NCT05091411
Clinical Trials of the Consistency and Non-inferiority Bridging Between Batches of Recombinant New Coronavirus Vaccine (CHO Cells)
A Phase 3 study testing Recombinant new coronavirus vaccine (CHO cell) group in people with Coronavirus Disease 2019, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic:Clinical trials of the consistency and non-inferiority bridging between batches of recombinant new coronavirus vaccine (CHO cells) Research purpose:Main purpose:1)To evaluate the interbatch consistency of immunogenicity of three batches of recombinant Novel Coronavirus vaccine (CHO cells) following… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Recombinant new coronavirus vaccine (CHO cell) group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,680 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2021to 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons aged 18-59 with full capacity for civil conduct;
- Subjects voluntarily participate in the study, sign informed consent, provide valid identification, understand and comply with the requirements of the study protocol;
- Female subjects of reproductive age agree to use effective contraceptive measures from the beginning of the study to 12 months after full vaccination.
Who cannot join
- Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
- Diastolic blood pressure ≥100mmHg and/or systolic blood pressure ≥160mmHg before screening;
- people who currently have or have a history of COVID-19;
- Persons suffering from the following diseases:
- ① have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;
- ② history of congenital or acquired immune deficiency or autoimmune disease; Received 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;
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- ③ Cancer patients (except basal cell carcinoma);
- ④ Patients with active tuberculosis, viral hepatitis and/or HIV antibody positive or syphilis specific antibody positive;
- ⑤ Neurological disease or family history (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;
- ⑥ Functional absence of spleen, and absence of spleen or splenectomy caused by any reason;
- ⑦ Serious chronic diseases or diseases in the advanced stage can not be controlled smoothly, such as diabetes, thyroid diseases;
- ⑧ Severe liver and kidney diseases; Any current respiratory illness requiring routine medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any exacerbation of respiratory illness (e.g., exacerbation of asthma) within the last 5 years; A history of serious cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis.
- A history of severe allergy to any vaccine, or to any component of the test vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angiopantic edema, etc.;
- Subunit vaccine and inactivated vaccine should be administered within 14 days before the first dose of vaccine, and live attenuated vaccine should be administered within 30 days;
- Have received blood or blood-related products, including immunoglobulin, within 3 months; Or planned use from the beginning of the study to 1 month after full vaccination;
- Those who have participated in or are participating in other CLINICAL trials related to COVID-19, or who have received COVID-19 vaccines;
- Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test);
- 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, 1 recruiting
- Recruiting
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 411228
Tao Huang, 15084736658, ymlc01@hncdc.com
About this study
Official title: Randomized, Double-blind, Parallel-controlled Evaluation of the Immunogenicity Consistency and Safety of the Three Batches of Recombinant Novel Coronavirus Vaccine (CHO Cells) After Process Verification in the 18-59-year-old Population, and the Comparison With the Pilot-scale Batch Immunogenicity Non-inferiority Bridging and Safety Clinical Trials
Popular topic:Clinical trials of the consistency and non-inferiority bridging between batches of recombinant new coronavirus vaccine (CHO cells) Research purpose:Main purpose:1)To evaluate the interbatch consistency of immunogenicity of three batches of recombinant Novel Coronavirus vaccine (CHO cells) following process validation in 18-59 year olds. 2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and pilot scale batch after process validation in 18-59 years of age. Secondary purpose:1)To evaluate the safety of each batch of recombinant Novel Coronavirus vaccine (CHO cells) in patients aged 18-59 years.2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and commercial batch after process validation in 18-59 years of age.
Overall design:This trial adopts a randomized, double-blind, parallel controlled trial design. Study population:The study involved people aged 18-59. Test groups:A total of 1680 subjects were enrolled in this clinical trial and randomly divided into 4 groups at 1:1:1:1 (pilot scale batch: process verification batch 1: process verification batch 2: process verification batch 3) , 420 cases per group.
Read the detailed description
Overall design: In this study, a randomized, double-blind, parallel-controlled trial design was used to evaluate the inter-batch consistency of immunogenicity of the three batches of recombinant Novel Coronavirus vaccine (CHO cells) after process validation in 18-59 year olds and the non-inferiority of immunogenicity between the three batches after process validation and the pilot scale batches. Non-inferiority of immunogenicity between the three batches after process validation and the commercial scale batches (clinical trials have been conducted), and the safety of each vaccine batch after vaccination was evaluated.
Intervention: Group A: 3 doses of experimental vaccine (pilot scale batch) were given at day 0, 30 and 60; Group B: 3 doses of experimental vaccine (process validation lot 1) at day 0, 30 and 60; Group C: 3 doses of experimental vaccine (process validation lot 2) at day 0, 30 and 60; Group D: 3 doses of experimental vaccine (process validation lot 3) at day 0, 30 and 60;
Immunogenicity observation:Blood samples were collected before the first dose and 14 days after the whole immunization, and the serum was separated for detection of live virus neutralizing antibodies (CPE method).
Safety observation:
(1) All adverse events (AE) were collected 30 minutes after each dose, all AE (including both solicitation and non-solicitation AE) at 0-7 days, and all AE (non-solicitation AE) at 8-30 days.
Solicitation AE (the following events occurring within 7 days of vaccination) :
- Adverse events at the inoculation site (local) : pain, swelling, induration, redness, rash, pruritus;
- Vital signs: fever;
- Non-inoculated site (systemic) adverse events: headache, fatigue/fatigue, nausea, vomiting, diarrhea, muscle pain (non-inoculated site), cough, acute allergic reactions. (2) All SAE were collected from the first dose to 12 months after full immunization.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Recombinant new coronavirus vaccine (CHO cell) group
- 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) groupBiological
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
| Study group | Role | What they receive |
|---|---|---|
| Population Ⅰ | Experimental | 3 doses of experimental vaccine (pilot scale batch) were given at day 0, 30 and 60. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
| Population Ⅱ | Experimental | 3 doses of experimental vaccine (process validation lot 1) at day 0, 30 and 60; Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
| Population Ⅲ | Experimental | 3 doses of experimental vaccine (process validation lot 2) at day 0, 30 and 60; Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
| Population Ⅳ | Experimental | 3 doses of experimental vaccine (process validation lot 3) were given at day 0, 30 and 60. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity endpoint
GMT and positive rate of SARS-COV-2 neutralizing antibody 14 days after vaccination with recombinant Novel Coronavirus vaccine (CHO cells)
Measured: 14 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start9 Sep 2021
- Primary completionNov 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- 1,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Huang, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091411
- Sponsor's protocol ID
- LKM-2021-NCV02
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel-controlled Evaluation of the Immunogenicity Consistency and Safety of the Three Batches of Recombinant Novel Coronavirus Vaccine (CHO Cells) After Process Verification in the 18-59-year-old Population, and the Comparison With the Pilot-scale Batch Immunogenicity Non-inferiority Bridging and Safety Clinical Trials
- ClinicalTrials.gov ID
- NCT05091411
- Acronym / sponsor ID
- LKM-2021-NCV02
- Conditions
- Coronavirus Disease 2019
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,680 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Oct 2021 (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:Clinical trials of the consistency and non-inferiority bridging between batches of recombinant new coronavirus vaccine (CHO cells) Research purpose:Main purpose:1)To evaluate the interbatch consistency of immunogenicity of three batches of recombinant Novel Coronavirus vaccine (CHO cells) following process validation in 18-59 year olds. 2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and pilot scale batch after process validation in 18-59 years of age. Secondary purpose:1)To evaluate the safety of each batch of recombinant Novel Coronavirus vaccine (CHO cells) in patients aged 18-59 years.2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and commercial batch after process validation in 18-59 years of age.
Overall design:This trial adopts a randomized, double-blind, parallel controlled trial design. Study population:The study involved people aged 18-59. Test groups:A total of 1680 subjects were enrolled in this clinical trial and randomly divided into 4 groups at 1:1:1:1 (pilot scale batch: process verification batch 1: process verification batch 2: process verification batch 3) , 420 cases per group.
Detailed description
Overall design: In this study, a randomized, double-blind, parallel-controlled trial design was used to evaluate the inter-batch consistency of immunogenicity of the three batches of recombinant Novel Coronavirus vaccine (CHO cells) after process validation in 18-59 year olds and the non-inferiority of immunogenicity between the three batches after process validation and the pilot scale batches. Non-inferiority of immunogenicity between the three batches after process validation and the commercial scale batches (clinical trials have been conducted), and the safety of each vaccine batch after vaccination was evaluated.
Intervention: Group A: 3 doses of experimental vaccine (pilot scale batch) were given at day 0, 30 and 60; Group B: 3 doses of experimental vaccine (process validation lot 1) at day 0, 30 and 60; Group C: 3 doses of experimental vaccine (process validation lot 2) at day 0, 30 and 60; Group D: 3 doses of experimental vaccine (process validation lot 3) at day 0, 30 and 60;
Immunogenicity observation:Blood samples were collected before the first dose and 14 days after the whole immunization, and the serum was separated for detection of live virus neutralizing antibodies (CPE method).
Safety observation:
(1) All adverse events (AE) were collected 30 minutes after each dose, all AE (including both solicitation and non-solicitation AE) at 0-7 days, and all AE (non-solicitation AE) at 8-30 days.
Solicitation AE (the following events occurring within 7 days of vaccination) :
- Adverse events at the inoculation site (local) : pain, swelling, induration, redness, rash, pruritus;
- Vital signs: fever;
- Non-inoculated site (systemic) adverse events: headache, fatigue/fatigue, nausea, vomiting, diarrhea, muscle pain (non-inoculated site), cough, acute allergic reactions. (2) All SAE were collected from the first dose to 12 months after full immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Population Ⅰ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) group3 doses of experimental vaccine (pilot scale batch) were given at day 0, 30 and 60. |
| Population Ⅱ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) group3 doses of experimental vaccine (process validation lot 1) at day 0, 30 and 60; |
| Population Ⅲ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) group3 doses of experimental vaccine (process validation lot 2) at day 0, 30 and 60; |
| Population Ⅳ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) group3 doses of experimental vaccine (process validation lot 3) were given at day 0, 30 and 60. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Persons aged 18-59 with full capacity for civil conduct;
- Subjects voluntarily participate in the study, sign informed consent, provide valid identification, understand and comply with the requirements of the study protocol;
- Female subjects of reproductive age agree to use effective contraceptive measures from the beginning of the study to 12 months after full vaccination.
Key exclusion criteria (18 listed)
- Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
- Diastolic blood pressure ≥100mmHg and/or systolic blood pressure ≥160mmHg before screening;
- people who currently have or have a history of COVID-19;
- Persons suffering from the following diseases:
- ① have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;
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 arm of 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population Ⅰ, Population Ⅱ, Population Ⅲ, Population Ⅳ |
Primary outcome
Immunogenicity endpoint
Time frame: 14 days after vaccination
GMT and positive rate of SARS-COV-2 neutralizing antibody 14 days after vaccination with recombinant Novel Coronavirus vaccine (CHO cells)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- 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 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 3 study testing Recombinant new coronavirus vaccine (CHO cell) group in people with Coronavirus Disease 2019, 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 18 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 25 Oct 2021. 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 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?
Contact Tao Huang (15084736658, ymlc01@hncdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity endpoint (time frame: 14 days after vaccination). 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 25 Oct 2021.