Omicron BA.4/5-Delta COVID-19 Vaccine Phase I Clinical Trial
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06043388 |
Recruitment Status :
Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 25, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) Biological: Placebo | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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. |
Estimated Study Start Date : | September 2023 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | November 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Group 1
Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cell)
|
Biological: 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 |
Placebo Comparator: Group 2
physiological saline
|
Biological: Placebo
Inoculate one dose, 0.5ml,Intramuscular injection into the deltoid muscle of the upper arm |
- Safety endpoint [ Time Frame: Within 12 months after vaccination ]Incidence of AEs&SAE&AESI
- Immunogenicity endpoint [ Time Frame: 14 days after vaccination ]Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043388
Contact: Junshi Zhao, Master | 17788903138 | ymlc02@hncdc.com |
Principal Investigator: | Junshi Zhao, Master | Hunan Provincial Center for Disease Control and Prevention |
Responsible Party: | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT06043388 |
Other Study ID Numbers: |
LKM-2023-NCV-V04 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 25, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |