Healthy VolunteersPhase 1NCT06314880
Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli)
A Phase 1 study testing Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose) and Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose) in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose) and Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2023to 30 Dec 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 3 months to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, 530028
Lirong Huang, +86-13978620932
About this study
Official title: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluation the Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli) in a Population Aged 3 Months-50 Years Old
The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.
Read the detailed 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.
- Conditions
- Healthy Volunteers
- Being tested
- Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose), Placebo control
- Keywords
- Recombinant Meningococcal Group B Vaccine (E. Coli)
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)Biological
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)Biological
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 controlBiological
Placebo control. 20 people/group.
| Study group | Role | What they receive |
|---|---|---|
| 18-50 years old | Experimental | 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. Receives: Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control |
| 6-17 years old | Experimental | 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. Receives: Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control |
| 2-5 years old | Experimental | 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. Receives: Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control |
| 6-23 months old | Experimental | 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. Receives: Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control |
| 3-5 months old | Experimental | 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. Receives: Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 0-30 days after vaccination
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)
Measured: within 30 minutes after vaccination
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)
Measured: within 0-14 days vaccination
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)
Measured: within 0-30 days vaccination
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)
Measured: within 0-30 days vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start22 Jul 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314880
- Sponsor's protocol ID
- 2022112701
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluation the Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli) in a Population Aged 3 Months-50 Years Old
- ClinicalTrials.gov ID
- NCT06314880
- Acronym / sponsor ID
- 2022112701
- Conditions
- Healthy Volunteers
- Keywords
- Recombinant Meningococcal Group B Vaccine (E. Coli)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Mar 2024 (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 research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 18-50 years old | Experimental | Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose), Biological: Placebo control60 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. |
| 6-17 years old | Experimental | Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose), Biological: Placebo control60 people per age group. Divided into high-dose group, low-dose group, and placebo group. |
| 2-5 years old | Experimental | Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose), Biological: Placebo control60 people per age group. Divided into high-dose group, low-dose group, and placebo group. |
| 6-23 months old | Experimental | Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose), Biological: Placebo control60 people per age group. Divided into high-dose group, low-dose group, and placebo group. |
| 3-5 months old | Experimental | Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose), Biological: Placebo control60 people per age group. Divided into high-dose group, low-dose group, and placebo group. |
Who may qualify
- Ages
- 3 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (18 listed)
- 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;
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 |
|---|---|---|
| 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. | Biological | 18-50 years old, 2-5 years old, 3-5 months old, 6-17 years old, 6-23 months old |
| 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. | Biological | 18-50 years old, 2-5 years old, 3-5 months old, 6-17 years old, 6-23 months old |
| Placebo controlPlacebo control. 20 people/group. | Biological | 18-50 years old, 2-5 years old, 3-5 months old, 6-17 years old, 6-23 months old |
Primary outcome
The incidence rate of all AEs within 0-30 days after each dose of vaccination
Time frame: within 0-30 days after vaccination
All AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)
The incidence rate of solicited AEs within 30 minutes after each dose of vaccination
Time frame: within 30 minutes after vaccination
All solicited AEs occurrence within 30 minutes after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)
The incidence rate of solicited AEs within 0-14 days after each dose of vaccination
Time frame: within 0-14 days vaccination
All solicited AEs occurrence within 0-14 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)
The incidence rate of unsolicited AEs within 0-30 days after each dose of vaccination
Time frame: within 0-30 days vaccination
All unsolicited AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)
The incidence rate of grade 3 and higher AEs within 0-30 days after each dose of vaccination
Time frame: within 0-30 days 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Lin Du study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose) and Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose) in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
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 7 inclusion and 18 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Wenjian Fang (+86-18611630252, fangwenjian@zhifeishengwu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of all AEs within 0-30 days after each dose of vaccination (time frame: within 0-30 days after vaccination). The study lists 5 primary outcomes in all. 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 3 Apr 2024.