Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06314880
Other study ID # 2022112701
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 22, 2023
Est. completion date December 30, 2024

Study information

Verified date February 2024
Source Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Contact Wenjian Fang
Phone +86-18611630252
Email fangwenjian@zhifeishengwu.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.


Description:

This is a Phase I, single center, randomized, double-blind, placebo-controlled clinical trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity. Expected to include 300 subjects, divide them into 5 age groups of 18-50 years old, 6-17 years old, 2-5 years old, 6-23 months old, and 3-5 months old, and 2 dose groups, a total of 10 groups, with 30 people in each group. The experimental group and placebo control group are 20 people and 10 people, respectively.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Months to 50 Years
Eligibility Inclusion Criteria: - Age range from 3 months to 50 years old, legal guardian and/or individual can provide legal identification; - 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: - Have received any Group B meningococcal vaccine in the past; - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.

Locations

Country Name City State
China Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention Nanning Guangxi

Sponsors (1)

Lead Sponsor Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence rate of all AEs within 0-30 days after each dose of vaccination All AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) within 0-30 days after vaccination
Primary The incidence rate of solicited AEs within 30 minutes after each dose of vaccination All solicited AEs occurrence within 30 minutes after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) within 30 minutes after vaccination
Primary The incidence rate of solicited AEs within 0-14 days after each dose of vaccination All solicited AEs occurrence within 0-14 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) within 0-14 days vaccination
Primary The incidence rate of unsolicited AEs within 0-30 days after each dose of vaccination All unsolicited AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) within 0-30 days vaccination
Primary The incidence rate of grade 3 and higher AEs within 0-30 days after each dose of vaccination All grade 3 and higher AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) within 0-30 days vaccination
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1