COVID-19Phase 1NCT06043388
Omicron BA.4/5-Delta COVID-19 Vaccine Phase I Clinical Trial
A Phase 1 study testing Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..
Trial summary
The purpose of this study is to evaluate the safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) after vaccination in people aged 18 and over. 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?
- Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Nov 2024
- Phase
- Phase 1
- 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
- Aged 18 and above when signing the informed consent form;
- The subject himself voluntarily participates in this research, and signs the informed consent form, and can provide legal identification, understand and abide by the requirements of the trial protocol;
- Female subjects of childbearing age and male subjects must agree to take effective contraceptive measures during the study.
Who cannot join
- Less than 6 months since the last COVID-19 infection or COVID-19 vaccination；
- Prior history of severe allergy to any vaccine, or to any component of the experimental vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, allergy (such as allergy to two or more drugs, food or pollen);
- Suspected or confirmed fever (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃) within 72 hours before enrollment, or axillary body temperature ≥37.3℃/ mouth temperature ≥37.5℃ on the day of enrollment;
- Patients with uncontrolled lymphoproliferative disease, unmitigated aplastic anemia, primary immune thrombocytopenia (ITP) activity, uncontrolled coagulation disease, etc.;
- a history of congenital or acquired immunodeficiency or autoimmune disease; Absence of spleen, or history of splenic surgery, trauma or immunomodulator treatment within 6 months, such as immunosuppressive dose of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day for more than a week); Or monoclonal antibodies; Thymosin; Or interferon; Topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted;
- Non-live vaccine should be administered within 14 days before vaccination, and live attenuated vaccine should be administered within 30 days;
Show all 14Show fewer
- Patients with malignant tumors who are undergoing chemotherapy, radiotherapy, immunotherapy, etc., before and after surgery; Patients with organ transplant status;
- People with uncontrolled epilepsy and other progressive neurological disorders (e.g. Transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
- Patients with acute disease, or acute onset of chronic disease, or uncontrolled severe chronic disease, such as medically uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
- Participants who had used blood and blood-related products within 3 months prior to enrollment;
- Participants who have participated in or are participating in other clinical trials (including drugs and devices) within 3 months prior to the clinical trial;
- Women of childbearing age have had unprotected sexual activity within 14 days prior to enrollment
- lactating women or women during pregnancy;
- The investigator determined that the subject had any disease or condition that would put the subject at risk, that the subject would not be able to complete the trial as required by the protocol, or that there would be conditions that would interfere with the evaluation of vaccine response.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) in People Aged 18 Years and Above.
The purpose of this study is to evaluate the safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) after vaccination in people aged 18 and over. It is planned to screen 100 subjects who are 18 years old and above and more than 6 months since the last new coronavirus infection or new coronavirus vaccine. All subjects collected venous blood before vaccination, 14 days, 3 months, and 6 months after vaccination for immunological detection of neutralizing antibody of the new coronavirus prototype strain, Delta strain and Omicron strain (BA.4/5, XBB); All adverse events (AEs) within 30 minutes after vaccination, all AEs (including solicited and non-solicited AEs) on days 0-7, all AEs (non-solicited AEs) on days 8-30, and all AEs within 12 months after vaccination were collected. serious adverse events (SAE) and adverse events of special interest (AESI).
Read the detailed description
Solicitation AEs (the following events occurring within 7 days of vaccination):
AESI:
Select 100 cases of people aged 18 years and above and more than 6 months after the last new coronavirus infection or vaccination, and evaluate the effectiveness of Omicron BA.4/5-Delta strain recombinant new coronavirus protein vaccine (CHO cells) in people aged 18 years and above. Safety after vaccination in the population.
Non-vaccination site (systemic) adverse events: fever, headache, fatigue/asthenia, nausea, vomiting, diarrhea, myalgia (non-vaccination site), cough, acute allergic reaction.
Venous blood was collected from all subjects before vaccination, 14 days, 3 months, and 6 months after vaccination for immunological detection of neutralizing antibodies against the new coronavirus prototype strain, Delta strain, and Omicron strain (BA.4/5, XBB).
Adverse events at the vaccination site (local): pain, swelling, induration, redness, rash, itching; Myocarditis/pericarditis, thrombosis, thrombocytopenia, etc., immune-related diseases (psoriasis, rheumatoid arthritis, etc.), nervous system-related diseases (Glibari syndrome, peripheral neuropathy, Bell's palsy).
Pregnancy events that occurred within 12 months after vaccination of subjects in this trial were collected, and neonates whose pregnancy outcome was delivery during the study period were followed up for long-term safety (follow-up until 12 months after delivery).
Immunogenicity observation:
Safety observations:
AEs, AESIs and SAEs: collect all adverse events (AEs) 30 minutes after vaccination, all AEs 0-7 days (including solicited and non-solicited AEs), 8-30 days all AEs (non-solicited AEs), vaccination All serious adverse events (SAEs) and adverse events of special interest (AESIs) within the last 12 months.
- Conditions
- COVID-19
- Being tested
- Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)Biological
Inoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm
PlaceboBiological
Inoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cell) Receives: Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) |
| Group 2 | Placebo comparator | physiological saline Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint
Incidence of AEs\&SAE\&AESI
Measured: Within 12 months after vaccination
Secondary outcomes (1)
Immunogenicity endpoint
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody
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 posted21 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionNov 2024 (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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
- Responsible party
- Sponsor
- Investigators
- Junshi Zhao, Master, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043388
- Sponsor's protocol ID
- LKM-2023-NCV-V04
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 25 Sep 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) in People Aged 18 Years and Above.
- ClinicalTrials.gov ID
- NCT06043388
- Acronym / sponsor ID
- LKM-2023-NCV-V04
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 21 Sep 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.
The purpose of this study is to evaluate the safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) after vaccination in people aged 18 and over. It is planned to screen 100 subjects who are 18 years old and above and more than 6 months since the last new coronavirus infection or new coronavirus vaccine. All subjects collected venous blood before vaccination, 14 days, 3 months, and 6 months after vaccination for immunological detection of neutralizing antibody of the new coronavirus prototype strain, Delta strain and Omicron strain (BA.4/5, XBB); All adverse events (AEs) within 30 minutes after vaccination, all AEs (including solicited and non-solicited AEs) on days 0-7, all AEs (non-solicited AEs) on days 8-30, and all AEs within 12 months after vaccination were collected. serious adverse events (SAE) and adverse events of special interest (AESI).
Detailed description
Solicitation AEs (the following events occurring within 7 days of vaccination):
AESI:
Select 100 cases of people aged 18 years and above and more than 6 months after the last new coronavirus infection or vaccination, and evaluate the effectiveness of Omicron BA.4/5-Delta strain recombinant new coronavirus protein vaccine (CHO cells) in people aged 18 years and above. Safety after vaccination in the population.
Non-vaccination site (systemic) adverse events: fever, headache, fatigue/asthenia, nausea, vomiting, diarrhea, myalgia (non-vaccination site), cough, acute allergic reaction.
Venous blood was collected from all subjects before vaccination, 14 days, 3 months, and 6 months after vaccination for immunological detection of neutralizing antibodies against the new coronavirus prototype strain, Delta strain, and Omicron strain (BA.4/5, XBB).
Adverse events at the vaccination site (local): pain, swelling, induration, redness, rash, itching; Myocarditis/pericarditis, thrombosis, thrombocytopenia, etc., immune-related diseases (psoriasis, rheumatoid arthritis, etc.), nervous system-related diseases (Glibari syndrome, peripheral neuropathy, Bell's palsy).
Pregnancy events that occurred within 12 months after vaccination of subjects in this trial were collected, and neonates whose pregnancy outcome was delivery during the study period were followed up for long-term safety (follow-up until 12 months after delivery).
Immunogenicity observation:
Safety observations:
AEs, AESIs and SAEs: collect all adverse events (AEs) 30 minutes after vaccination, all AEs 0-7 days (including solicited and non-solicited AEs), 8-30 days all AEs (non-solicited AEs), vaccination All serious adverse events (SAEs) and adverse events of special interest (AESIs) within the last 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cell) |
| Group 2 | Placebo comparator | Biological: Placebophysiological saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 and above when signing the informed consent form;
- The subject himself voluntarily participates in this research, and signs the informed consent form, and can provide legal identification, understand and abide by the requirements of the trial protocol;
- Female subjects of childbearing age and male subjects must agree to take effective contraceptive measures during the study.
Key exclusion criteria (14 listed)
- Less than 6 months since the last COVID-19 infection or COVID-19 vaccination；
- Prior history of severe allergy to any vaccine, or to any component of the experimental vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, allergy (such as allergy to two or more drugs, food or pollen);
- Suspected or confirmed fever (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃) within 72 hours before enrollment, or axillary body temperature ≥37.3℃/ mouth temperature ≥37.5℃ on the day of enrollment;
- Patients with uncontrolled lymphoproliferative disease, unmitigated aplastic anemia, primary immune thrombocytopenia (ITP) activity, uncontrolled coagulation disease, etc.;
- a history of congenital or acquired immunodeficiency or autoimmune disease; Absence of spleen, or history of splenic surgery, trauma or immunomodulator treatment within 6 months, such as immunosuppressive dose of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day for more than a week); Or monoclonal antibodies; Thymosin; Or interferon; Topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted;
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 |
|---|---|---|
| Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)Inoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm | Biological | Group 1 |
| PlaceboInoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm | Biological | Group 2 |
Primary outcome
Safety endpoint
Time frame: Within 12 months after vaccination
Incidence of AEs\&SAE\&AESI
1 secondary outcome
Immunogenicity endpoint
Time frame: 14 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- 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.
Junshi Zhao, Master principal investigator
Hunan Provincial Center for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..
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 14 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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.
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 Junshi Zhao, Master (17788903138, ymlc02@hncdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint (time frame: Within 12 months 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 Sep 2023.