- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05663086
Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above
September 24, 2023 updated by: Guangzhou Patronus Biotech Co., Ltd.
A Randomized, Blinded, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above(Negative for Antibody Against COVID-19)
This is a randomized, blinded, positive-controlled study to evaluate the immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above(negative antibody against COVID-19).
720 subjects will be recruited in this study, including 360 in 1 dose of 30 or 60 μg group and 360 in 2 doses of 30 or 60 μg group.
The age group consists of 18-59 years old and 60 years old and above.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Subjects will receive 1 dose or 2 doses of LYB001, according to the immunization schedule of 0 day or 0, 28 days.
The adverse events within 28 days after each vaccination will be observed.
In addition, blood samples will be collected on day 0 before vaccination,and on day 7, 14, 28 and month 3, 6, 12 after full vaccination.
Serum antibody levels, cellular immune responses will be analyzed to evaluate the immunogenicity and immune persistence of the vaccine.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Jiangsu Provincial Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- People aged 18 years and above who have not received COVID-19 vaccine or whose last vaccination was at least 6 months ago (at the time of screening).
- Participate the trial voluntarily and sign informed consent form.
- Subjects are willing to comply with the requirements of the clinical trial protocol and complete the study follow-up.
- Armpit temperature ≤37.0℃ on the day of enrollment.
- 2019 Novel Coronavirus (COVID-19) Antibody was negative.
Exclusion Criteria:
- Known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines
- History of severe acute respiratory syndrome (SARS) and/or Middle East respiratory syndrome (MERS) or COVID-19 infection or disease;
- Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
- vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment;
- Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial;
Patients with the following diseases:
- Any acute disease or in the acute phase of chronic diseases within 7 days before enrollment;
- Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
- History of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids;
- Positive for anti-AIDS antibody;
- Neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history;
- Asplenia or functional asplenia;
- Serious or uncontrollable cardiovascular diseases, diabetes,hematological and lymphatic diseases, immune system diseases,liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization;
- Contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant;
- Severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) .
- History of major surgery within 12 weeks before enrollment (judged by the investigator), or incomplete recovery after surgery, or planning major surgery during the trial;
- Participating or will participate other clinical trials during this trial;
- Any disease or condition that would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine.
- Women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-dose vaccine
30μg LYB001 is to be used in the clinical trial.
The number of each arm is 60.
|
The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated at day 0 and 28.
Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
|
Experimental: High-dose vaccine
60μg LYB001 is to be used in the clinical trial.
The number of each arm is 60.
|
The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated at day 0 and 28.
Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
|
Active Comparator: Positive control
Positive-controlled vaccine is to be used in the clinical trial.
The number of each arm is 60.
|
The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated at day 0 and 28.
Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Time Frame: Day 14 after full vaccination.
|
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.
|
Day 14 after full vaccination.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The occurrence of adverse events
Time Frame: 30 mins,7 days and 28 days after each vaccination
|
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination
|
30 mins,7 days and 28 days after each vaccination
|
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)
Time Frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day14, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
|
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Time Frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
|
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
GMT of binding antibody against S protein of SARS-CoV-2 wild strain.
Time Frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
GMT of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
|
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain.
Time Frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
|
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain.
Time Frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
|
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time Frame: Day 0 to 12 months after dose1and dose2
|
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1 and dose2
|
Day 0 to 12 months after dose1and dose2
|
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Time Frame: Day 7 , day 28 ,month 3, month 6, month 12 after full vaccination
|
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 7, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
|
Day 7 , day 28 ,month 3, month 6, month 12 after full vaccination
|
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs).
Time Frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
|
Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Fengcai Zhu, Jiangsu Provincial Center for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2023
Primary Completion (Actual)
June 27, 2023
Study Completion (Actual)
June 27, 2023
Study Registration Dates
First Submitted
December 22, 2022
First Submitted That Met QC Criteria
December 22, 2022
First Posted (Actual)
December 23, 2022
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 24, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYB001/CT-CHN-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
Clinical Trials on One dose group
-
James Tarbox, MDTexas Tech University Health Sciences CenterRecruitingPenicillin AllergyUnited States
-
Institute of Medical Biology, Chinese Academy of...Sichuan Center for Disease Control and PreventionRecruitingPertussis | Tetanus | DiphtheriaChina
-
Innovent Biologics (Suzhou) Co. Ltd.Completed
-
Centre de Recherche de l'Institut Universitaire...Active, not recruitingUrinary Incontinence | Urinary Stress IncontinenceCanada
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Provincial Health Services Authority and other collaboratorsCompletedChronic Obstructive Pulmonary Disease (COPD)Canada
-
University of UlsterCompletedSchizophrenia | Bipolar Disorder | Major Depression | Mental Illness | PsychosisIreland, United Kingdom
-
Dasman Diabetes InstituteCompletedDiabetes Mellitus | New Onset Diabetes After TransplantKuwait
-
Gennaro SardellaUnknownNon ST Segment Elevation MI and Unstable AnginaItaly
-
Centers for Disease Control and PreventionWest Virginia UniversityWithdrawn