COVID-19NCT05574985
Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)
A study testing Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) and Inactivated COVID-19 vaccine (Vero Cell) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic:A Clinical Study of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) Overall design:The study was designed as a randomized, open and controlled study. Study population: People aged 18 years and above and 6-15 months after the completion of basic immunization or 6-9 months after the completion of… 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 Omicron-Delta COVID-19 Vaccine (CHO Cell) and Inactivated COVID-19 vaccine (Vero Cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2022to 18 Mar 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At the time of signing the Informed Consent, he was 18 years old or above;
- Normal body temperature (axillary temperature < 37.3 ℃/oral temperature < 37.5 ℃);
- Meet one of the following conditions: 1) 6-15 months after the basic immunization (2 injections) of the inactivated vaccine of the prototype strain of COVID-19-19 has been completed; 2) 6-9 months after the booster immunization (3 injections) of the inactivated vaccine of the prototype strain of COVID-19 has been completed; 3) 6-15 months after basic immunization (3 injections) of recombinant vaccine of COVID-19 prototype strain has been completed.
- The vaccines used to complete the above basic immunization or enhanced immunization were produced by Beijing Biotech, Wuhan Biotech, Sinovac and Zhifeilong Koma, and the same kind of vaccine was inoculated throughout the whole process.
- Female subjects over 18 years old were not pregnant (blood pregnancy test was negative), were not in lactation and took effective contraceptive measures within 4 weeks after inoculation; The male subject must agree to take effective contraceptive measures by himself and his partner within 4 weeks after signing the informed consent and vaccination.
- Subjects have the ability to understand the research procedure, voluntarily sign the informed consent form after informed consent, can comply with the requirements of the clinical research protocol, and can and is willing to complete the entire required research plan.
Who cannot join
- A history of serious allergy to any vaccine in the past, or a history of serious allergy to any component of the studied vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, allergic constitution (such as allergic to two or more drugs, food or pollen);
- Confirmed cases of novel coronavirus infection, asymptomatic infections or positive history of novel coronavirus nucleic acid testing;
- Patients with uncontrollable lymphoproliferative disease, aplastic anemia, primary immune thrombocytopenia (ITP), and haemorrhagic disease;
- A history of congenital or acquired immunodeficiency or autoimmune diseases;
- The life expectancy of patients with malignant tumors is less than 1 year;
- Patients with uncontrolled epilepsy and other progressive nervous system diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
Show all 10Show fewer
- Patients with acute disease, or acute attack period of chronic disease, or uncontrolled severe chronic disease, such as hypertension beyond the control of drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- Those who have received inactivated vaccine within one week or attenuated vaccine within four weeks before vaccination;
- Subjects who have participated in other clinical studies or are participating in other clinical studies within 3 months;
- The investigator believes that the subject has any disease or condition that may put the subject at risk, that the subject cannot complete the study as required by the protocol, and that there are conditions that interfere with the evaluation of vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
About this study
Official title: A Randomized, Open, Positive Controlled Clinical Study to Evaluate the Immunogenicity and Safety of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) in People Aged 18 Years and Over
Popular topic:A Clinical Study of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) Overall design:The study was designed as a randomized, open and controlled study.
Study population: People aged 18 years and above and 6-15 months after the completion of basic immunization or 6-9 months after the completion of enhanced immunization with the new coronal prototype vaccine.
Test groups:Study group；Control group；Observation group ①；Observation group ②
Read the detailed description
Research topic: A randomized, open, positive controlled clinical study to evaluate the immunogenicity and safety of the recombinant novel coronavirus protein vaccine (CHO cell) of Omicron-Delta strain in people aged 18 years and above.
Product name:Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell),each dose contains 25μg DO-RBD protein/0.5mL/bottle.
Indications: Prevention of respiratory diseases caused by new coronavirus infection.
Research purpose:
Main purpose:To evaluate the immunogenicity of Omicron Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against new crown variants (Delta, Omicron BA. 2，Omicron BA. 5) in people aged 18 years and above.
Secondary objectives: To evaluate the safety of recombinant novel coronavirus protein vaccine (CHO cells) of Omicron Delta strain in people aged 18 years and above.
Research design:The study adopted a randomized, open and controlled design. Study group and control group: 150 patients who completed the basic immunization with inactivated new crown vaccine were randomly divided into study group and control group, and were injected with study vaccine and control vaccine respectively; Observation group ①: 75 patients who completed homologous booster immunization with inactivated new coronal vaccine were injected with one dose of study vaccine; Observation group ②: 75 patients who completed the basic immunization of new coronal recombinant vaccine were injected with one dose of study vaccine.
Safety endpoint:
- Incidence of all AEs occurring within 28 days after vaccination:(1)Total incidence of AEs;(2) Incidence of AEs associated with the investigational vaccine;(3) Incidence of AEs of Grade 3 or above;(4) Incidence of AEs associated with the investigational vaccine of Grade 3 or above;(5) Incidence of AEs resulting in withdrawal;(6)Incidence of AEs resulting in withdrawal that are associated with the investigational vaccine;
- Incidence of all serious adverse events (SAEs) within six months after vaccination, and incidence of vaccine-related SAEs.
Immunogenicity endpoint:
- Primary end point: GMT of neutralizing antibody in the serum of subjects against the SARS-CoV-2 Delta, BA.2, and BA.5 within 14 days after vaccination.
- Secondary end points:GMT of neutralizing antibody in the serum of subjects of the study group and the control group against SARS-CoV-2 Delta, BA.2, BA. 5 within six months after vaccination.
- Conditions
- COVID-19
- Being tested
- Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell), Inactivated COVID-19 vaccine (Vero Cell)
- Keywords
- Recombinant Vaccine, Omicron-Delta
- 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 Omicron-Delta COVID-19 Vaccine (CHO Cell)Biological
Injected one dose of research vaccine
Inactivated COVID-19 vaccine (Vero Cell)Biological
Injected one dose of control vaccine
| Study group | Role | What they receive |
|---|---|---|
| Research Group | Experimental | People 6 to 15 months after the completion of basic immunization with inactivated COVID-19 vaccine were vaccinated one dose of the study vaccine Receives: Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) |
| Control Group | Active comparator | People 6 to 15 months after the completion of basic immunization with inactivated COVID-19 vaccine were vaccinated with one dose of control vaccine Receives: Biological: Inactivated COVID-19 vaccine (Vero Cell) |
| Observation group ① | Experimental | People 6 to 9 months after the completion of the inactivated COVID-19 vaccine booster immunization were vaccinated one dose of the study vaccine Receives: Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) |
| Observation group ② | Experimental | People 6 to 15 months after the completion of basic immunization with COVID-19 recombinant vaccine were vaccinated one dose of the study vaccine Receives: Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity end point 1
Blood samples were collected from subjects on the 14th day after vaccination, and serum was obtained after centrifugation. Then, the geometric mean titer (GMT) of neutralizing antibodies against COVID-19 variants (Delta, Omicron BA.2，Omicron BA.5) was obtained from the serum samples of subjects on the 14th day after vaccination.
Measured: 14 days after vaccination
Safety end point 1
The contact card was recovered on the 28th day after vaccination, and the clinician determined whether there was an adverse event and entered it into the EDC system. After statistical analysis, the incidence of all adverse events within 28 days was determined.
Measured: 28 days after vaccination
Safety end point 2
At the end of 6 months after vaccination, through telephone follow-up, the clinician learned whether the subject had serious adverse events, entered the information into the EDC system, and determined the incidence of all serious adverse events within 6 months through statistical analysis.
Measured: 6 months after vaccination
Secondary outcomes (1)
Immunogenicity end point 4
Blood samples were collected from subjects at the end of 6 months after vaccination, and serum was obtained after centrifugation. Then, the geometric mean titer (GMT) of neutralizing antibodies against COVID-19 variants (Delta, Omicron BA.2，Omicron BA.5) was obtained from the serum samples of subjects.
Measured: 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start29 Aug 2022
- Primary completion9 Oct 2022
- Study completion18 Mar 2023
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Professor, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574985
- Sponsor's protocol ID
- LKM-2022-DO-NCV-01
- Status last verified
- Jul 2024
- First submitted
- 10 Oct 2022
- Last updated
- 26 Jul 2024
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Positive Controlled Clinical Study to Evaluate the Immunogenicity and Safety of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) in People Aged 18 Years and Over
- ClinicalTrials.gov ID
- NCT05574985
- Acronym / sponsor ID
- LKM-2022-DO-NCV-01
- Conditions
- COVID-19
- Keywords
- Recombinant Vaccine, Omicron-Delta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 18 Mar 2023 (actual)
- First posted
- 12 Oct 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.
Popular topic:A Clinical Study of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) Overall design:The study was designed as a randomized, open and controlled study.
Study population: People aged 18 years and above and 6-15 months after the completion of basic immunization or 6-9 months after the completion of enhanced immunization with the new coronal prototype vaccine.
Test groups:Study group；Control group；Observation group ①；Observation group ②
Detailed description
Research topic: A randomized, open, positive controlled clinical study to evaluate the immunogenicity and safety of the recombinant novel coronavirus protein vaccine (CHO cell) of Omicron-Delta strain in people aged 18 years and above.
Product name:Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell),each dose contains 25μg DO-RBD protein/0.5mL/bottle.
Indications: Prevention of respiratory diseases caused by new coronavirus infection.
Research purpose:
Main purpose:To evaluate the immunogenicity of Omicron Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against new crown variants (Delta, Omicron BA. 2，Omicron BA. 5) in people aged 18 years and above.
Secondary objectives: To evaluate the safety of recombinant novel coronavirus protein vaccine (CHO cells) of Omicron Delta strain in people aged 18 years and above.
Research design:The study adopted a randomized, open and controlled design. Study group and control group: 150 patients who completed the basic immunization with inactivated new crown vaccine were randomly divided into study group and control group, and were injected with study vaccine and control vaccine respectively; Observation group ①: 75 patients who completed homologous booster immunization with inactivated new coronal vaccine were injected with one dose of study vaccine; Observation group ②: 75 patients who completed the basic immunization of new coronal recombinant vaccine were injected with one dose of study vaccine.
Safety endpoint:
- Incidence of all AEs occurring within 28 days after vaccination:(1)Total incidence of AEs;(2) Incidence of AEs associated with the investigational vaccine;(3) Incidence of AEs of Grade 3 or above;(4) Incidence of AEs associated with the investigational vaccine of Grade 3 or above;(5) Incidence of AEs resulting in withdrawal;(6)Incidence of AEs resulting in withdrawal that are associated with the investigational vaccine;
- Incidence of all serious adverse events (SAEs) within six months after vaccination, and incidence of vaccine-related SAEs.
Immunogenicity endpoint:
- Primary end point: GMT of neutralizing antibody in the serum of subjects against the SARS-CoV-2 Delta, BA.2, and BA.5 within 14 days after vaccination.
- Secondary end points:GMT of neutralizing antibody in the serum of subjects of the study group and the control group against SARS-CoV-2 Delta, BA.2, BA. 5 within six months after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Research Group | Experimental | Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)People 6 to 15 months after the completion of basic immunization with inactivated COVID-19 vaccine were vaccinated one dose of the study vaccine |
| Control Group | Active comparator | Biological: Inactivated COVID-19 vaccine (Vero Cell)People 6 to 15 months after the completion of basic immunization with inactivated COVID-19 vaccine were vaccinated with one dose of control vaccine |
| Observation group ① | Experimental | Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)People 6 to 9 months after the completion of the inactivated COVID-19 vaccine booster immunization were vaccinated one dose of the study vaccine |
| Observation group ② | Experimental | Biological: Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell)People 6 to 15 months after the completion of basic immunization with COVID-19 recombinant vaccine were vaccinated one dose of the study vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At the time of signing the Informed Consent, he was 18 years old or above;
- Normal body temperature (axillary temperature < 37.3 ℃/oral temperature < 37.5 ℃);
- Meet one of the following conditions: 1) 6-15 months after the basic immunization (2 injections) of the inactivated vaccine of the prototype strain of COVID-19-19 has been completed; 2) 6-9 months after the booster immunization (3 injections) of the inactivated vaccine of the prototype strain of COVID-19 has been completed; 3) 6-15 months after basic immunization (3 injections) of recombinant vaccine of COVID-19 prototype strain has been completed.
- The vaccines used to complete the above basic immunization or enhanced immunization were produced by Beijing Biotech, Wuhan Biotech, Sinovac and Zhifeilong Koma, and the same kind of vaccine was inoculated throughout the whole process.
- Female subjects over 18 years old were not pregnant (blood pregnancy test was negative), were not in lactation and took effective contraceptive measures within 4 weeks after inoculation; The male subject must agree to take effective contraceptive measures by himself and his partner within 4 weeks after signing the informed consent and vaccination.
Key exclusion criteria (10 listed)
- A history of serious allergy to any vaccine in the past, or a history of serious allergy to any component of the studied vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, allergic constitution (such as allergic to two or more drugs, food or pollen);
- Confirmed cases of novel coronavirus infection, asymptomatic infections or positive history of novel coronavirus nucleic acid testing;
- Patients with uncontrollable lymphoproliferative disease, aplastic anemia, primary immune thrombocytopenia (ITP), and haemorrhagic disease;
- A history of congenital or acquired immunodeficiency or autoimmune diseases;
- The life expectancy of patients with malignant tumors is less than 1 year;
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 Omicron-Delta COVID-19 Vaccine (CHO Cell)Injected one dose of research vaccine | Biological | Observation group ①, Observation group ②, Research Group |
| Inactivated COVID-19 vaccine (Vero Cell)Injected one dose of control vaccine | Biological | Control Group |
Primary outcome
Immunogenicity end point 1
Time frame: 14 days after vaccination
Blood samples were collected from subjects on the 14th day after vaccination, and serum was obtained after centrifugation. Then, the geometric mean titer (GMT) of neutralizing antibodies against COVID-19 variants (Delta, Omicron BA.2，Omicron BA.5) was obtained from the serum samples of subjects on the 14th day after vaccination.
Safety end point 1
Time frame: 28 days after vaccination
The contact card was recovered on the 28th day after vaccination, and the clinician determined whether there was an adverse event and entered it into the EDC system. After statistical analysis, the incidence of all adverse events within 28 days was determined.
Safety end point 2
Time frame: 6 months after vaccination
At the end of 6 months after vaccination, through telephone follow-up, the clinician learned whether the subject had serious adverse events, entered the information into the EDC system, and determined the incidence of all serious adverse events within 6 months through statistical analysis.
1 secondary outcome
Immunogenicity end point 4
Time frame: 6 months after 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 26 Jul 2024.
- Individual participant dataSharing planned: No
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.
Huan Zhou, Professor principal investigator
The First Affiliated Hospital of Bengbu Medical University
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 Omicron-Delta COVID-19 Vaccine (CHO Cell) and Inactivated COVID-19 vaccine (Vero 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 6 inclusion and 10 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 26 Jul 2024. 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?
Immunogenicity end point 1 (time frame: 14 days after 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 26 Jul 2024.