Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli)
NCT ID: NCT06314880
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2023-07-22
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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18-50 years old
60 people per age group. The first 15 subjects in the 18-50 age group will serve as sentinels, with 10 in the experimental group and 5 in the control group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)
Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Placebo control
Placebo control. 20 people/group.
6-17 years old
60 people per age group. Divided into high-dose group, low-dose group, and placebo group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)
Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Placebo control
Placebo control. 20 people/group.
2-5 years old
60 people per age group. Divided into high-dose group, low-dose group, and placebo group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)
Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Placebo control
Placebo control. 20 people/group.
6-23 months old
60 people per age group. Divided into high-dose group, low-dose group, and placebo group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)
Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Placebo control
Placebo control. 20 people/group.
3-5 months old
60 people per age group. Divided into high-dose group, low-dose group, and placebo group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)
Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Placebo control
Placebo control. 20 people/group.
Interventions
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Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)
Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
Placebo control
Placebo control. 20 people/group.
Eligibility Criteria
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Inclusion Criteria
* The subjects and/or their legal guardians have the ability to understand the research procedures, agree to participate in the study (and/or their legal guardians agree to the child's participation in the study), and sign an informed consent form;
* The subjects and/or their legal guardians are able to participate in all planned follow-up visits;
* On the day of enrollment, the axillary temperature was less than 37.3 ℃;
* Standards for certain groups of people:
* Subjects ≥ 2 years old: laboratory test indicators (as specified in the protocol) within the normal range, or those with abnormalities but no clinical significance (evaluated by clinical doctors);
* Female participants of childbearing age: Agree to take effective contraceptive measures within 6 months from enrollment to full vaccination.
Exclusion Criteria
* A history of invasive diseases caused by meningococcus or gonococci;
* Pregnant or lactating women;
* Have any history of severe allergies to vaccines or drugs in the past, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura;
* Suffering from serious heart disease, liver disease, kidney disease, congenital malformations, developmental disorders, and genetic defects (including but not limited to Down syndrome, moderate to severe thalassemia, etc.) that may interfere with the progress or completion of the study;
* Diagnosed as having congenital or acquired immunodeficiency, or suspected of having serious chronic or systemic diseases that may interfere with the conduct or completion of the study, such as active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis infection, etc;
* Individuals with encephalopathy, uncontrolled epilepsy, seizures, and other progressive neurological disorders, or a history or family history of mental illness;
* Suffering from contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;
* Received immunosuppressive therapy within 3 months prior to vaccination, such as continuous use of systemic glucocorticoid therapy for more than 2 weeks, such as prednisone or similar drugs\>5mg/day (note: local and inhaled/nebulized steroids can be used);
* Asplenia or splenectomy, functional asplenia caused by any circumstances;
* Subjects with hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, suitable for adults);
* Suffering from acute illness or in the acute phase of chronic illness, or using antipyretic, analgesic, and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) three days before the first dose of vaccination;
* Within 7 days (≤ 7 days) prior to enrollment, received inactivated vaccines, and within 14 days (≤ 14 days) received live attenuated vaccines;
* Has received blood or blood related products or immunoglobulin (hepatitis B immunoglobulin is acceptable) within 3 months prior to enrollment;
* Premature infants (gestational age\<37 weeks), low birth weight infants (birth weight\<2500g), and infants with a history of abnormal labor (only applicable to the 3-5 month and 6-23 month age groups);
* Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
* Participating in or planning to participate in clinical trials of other drugs in the near future;
* The researchers believe that there are any conditions in the subjects that may interfere with the evaluation of the research objectives.
3 Months
50 Years
ALL
Yes
Sponsors
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Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lin Du
Role: STUDY_CHAIR
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Locations
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Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Lirong Huang
Role: primary
Other Identifiers
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2022112701
Identifier Type: -
Identifier Source: org_study_id
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