Neisseria Meningitidis Serogroup BPhase 1NCT07395739
A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
A Phase 1 study testing Bexsero® and Group B Meningococcal OMV Vaccine in people with Neisseria Meningitidis Serogroup B, run by Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks) at 1 site in Australia.
Trial summary
A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis Serogroup B
- What is being tested?
- Bexsero® and Group B Meningococcal OMV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Mar 2026to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants aged 18 to 50 years (inclusive) at the time of screening, who can provide valid legal identification.
- Willing and able to give written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Willing and able to comply with all study procedures and available for the entire duration of the study follow-up.
- Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at screening.
- For female participants at least 1 of the following conditions must apply:
- Is not of childbearing potential (WONCBP), defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by FSH level ≥40 mIU/mL); or ii) Is of childbearing potential (WOCBP), has negative pregnancy tests at screening and prior to the first vaccination, and agrees to: Practice true abstinence (where this is consistent with their usual lifestyle); or Use a highly effective method of contraception consistently from signing the consent form until 6 months after the last vaccination. Highly effective contraception includes hormonal contraception (oral, injected, implanted or transdermal) plus use of a condom, placement of an intrauterine device (IUD) or intrauterine system (IUS) plus use of a condom, or a vasectomized male partner (performed at least 6 months prior) who has been documented to no longer produce sperm - verbal confirmation through medical history review acceptable; or iii) Are in an exclusively same-sex relationship. iv) In addition, pre-menopausal women must agree not to donate their ova from signing the consent form until at 6 months after the last vaccination.
Show all 9Show fewer
- Females should not be currently breastfeeding, and should not breastfeed for the duration of the study.
- Male participants are able to participate if they:
- Practice true abstinence (where this is consistent with their usual lifestyle); or ii) Are surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or iii) If their female partner is a WOCBP, the male participant must use a condom and the WOCBP female partner must use a highly effective contraception method (i.e. established use of hormonal contraception started at least 30 days prior to Day 0/Visit 1; or placement or an IUD), from screening and for 6 months after the last vaccination; or iv) Are in an exclusively same sex relationship. v) In addition, non-sterile males must agree not to donate their sperm from signing the consent form until 6 months after the last vaccination.
Who cannot join
- 1. Oral temperature >37.5°C at screening or prior to vaccination 2. Previous vaccination with any Group B meningococcal vaccine (including GSK's Bexsero® or Pfizer's Trumenba®) or a history of invasive disease caused by Neisseria meningitidis.
- 3. Individuals with abnormal findings in pre-vaccination laboratory tests, vital signs, physical examination, or electrocardiogram (ECG) that are deemed clinically significant by the Investigator or delegate. 4. Known allergy or hypersensitivity to any component of the investigational vaccine, or a history of severe allergic reactions (including, but not limited to: anaphylaxis, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, Arthus reaction, dyspnea, angioneurotic edema, etc.).
- 5. Administration of any live-attenuated vaccine within 14 days (inclusive) prior to vaccination, or any other subunit, inactivated, or recombinant protein vaccine within 7 days (inclusive) before vaccination. 6. Acute illness or exacerbation of a chronic illness within 3 days prior to vaccination. 7. Use of antipyretics, analgesics, or anti-allergy medications within 24 hours prior to vaccination. 8. Long-term use of immunomodulators within 3 months prior to screening (e.g., systemic corticosteroids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day of prednisone or equivalent), or planned use during the study period. Note: Topical preparations (e.g., ointments, eye drops, inhalers, nasal sprays) are permitted.
- 9. Receipt of blood products and/or immunoglobulins within 3 months prior to vaccination, or planned administration during the study period. 10. Participants who have donated or lost more than 450 mL of blood within 30 days before the screening visit. 11. Participants with any severe underlying disease, congenital malformation, or ongoing medical condition that, in the judgment of the investigator or delegate, may pose a risk to the participant or interfere with the conduct, safety, or scientific validity of the trial. This includes, but is not limited to: active or latent tuberculosis (Mycobacterium tuberculosis), symptomatic or poorly controlled respiratory diseases such as asthma or chronic bronchitis, Down syndrome, thalassemia, heart disease, kidney disease, autoimmune disorders, atopic predisposition, Guillain-Barré syndrome, current skin diseases, etc.
- 12. Participants with encephalopathy, uncontrolled epilepsy, convulsions, other progressive neurological disorders, or a significant personal history of psychiatric disorders.
- 13. Contraindications to intramuscular injection, including, but not limitedto: diagnosed thrombocytopenia, any coagulation disorder, or current treatment with anticoagulants. 14. Asplenia, functional asplenia, or splenectomy due to any reason. 15. Planned relocation from the local area before trial completion or prolonged absences scheduled during the trial visit periods.
Show all 9Show fewer
- 16. Participation in another clinical trial involving an investigational or unregistered product (drug, vaccine, device, etc.) within 30 days prior to vaccination, or planned participation in any other clinical trial before the completion of this study. 17. Positive test for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) or syphilis at screening.
- 18. Participants with skin conditions that in the opinion of the investigator or delegate may interfere with the assessment of local adverse reactions (e.g., tattoos at the injection site, psoriasis, plaques affecting the skin in the deltoid area, etc.).
- 19. Any other condition which, in the opinion of the Investigator or delegate, may compromise the assessment of the trial objectives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Linear Early Phase Limited
Perth, Western Australia, 6009
About this study
Official title: A Phase I, Randomized, Double-blinded, Positive-Controlled Clinical Trial to Assess the Safety and Immunogenicity of the Group B Meningococcal OMV Vaccine (DX-104) in Adults Aged 18 to 50 Years
A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.
Read the detailed description
A total of 30 healthy participants will be enrolled and randomized (2:1) to receive DX-104 or Bexsero® (multicomponent meningococcal group B vaccine). Participants in both the DX-104 and Bexsero® groups will receive three doses of intramuscular vaccination at Months 0, 1, and 6.
After all participants have completed the 6-month safety and immunogenicity observations following full vaccination, the trial will be concluded.
- Conditions
- Neisseria Meningitidis Serogroup B
- Being tested
- Bexsero®, Group B Meningococcal OMV Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bexsero®Biological
Intramuscular injection; 0.5ml/pre-filled syringe. Administer the vaccine according to the 0, 1, 6-month schedule.
Group B Meningococcal OMV VaccineBiological
Also called DX-104
Intramuscular injection; 0.5ml/vial. Administer the vaccine according to the 0, 1, 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| DX-104 | Experimental | Participants in this arm will receive three doses of DX-104 at Months 0, 1, and 6. Receives: Biological: Group B Meningococcal OMV Vaccine |
| Bexsero® | Active comparator | Participants in this arm will receive three doses of Bexsero® at Months 0, 1, and 6. Receives: Biological: Bexsero® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the overall safety of DX-104
- The incidence and severity of any AEs within 30 days after each vaccination.
- The incidence and severity of any AEs within 30 minutes after each vaccination.
- The incidence and severity of any solicited local and systemic AEs within 7 days after each vaccination.
- The incidence and severity of any unsolicited AEs within 30 days after each vaccination.
- The occurrence of clinically significant laboratory abnormalities on Day 3 after each vaccination.
- The incidence of any serious adverse events (SAEs) from the first vaccination until 6 months after the last vaccination.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (6)
To evaluate the immunogenicity of DX-104
Geometric mean titers (GMTs) of serum bactericidal antibody against meningococcal B strains, as measured by serum bactericidal assays using human complement (hSBA), at Day 30 following each vaccination and at 6 months after the last vaccination.
Measured: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Geometric mean-fold rise (GMFR) relative to baseline of serum bactericidal antibody against meningococcal B strains, as measured by serum bactericidal assays using human complement (hSBA), at Day 30 following each vaccination and at 6 months after the last vaccination.
Measured: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Seroconversion rate (SCR) of serum bactericidal antibody against meningococcal B strains, as measured by serum bactericidal assays using human complement (hSBA), at Day 30 following each vaccination and at 6 months after the last vaccination.
Measured: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Geometric mean titers (GMTs) of Immunoglobulin G (IgG) against meningococcal B strains, as measured by ELISA, at Day 30 following each vaccination and at 6 months after the last vaccination.
Measured: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Geometric mean-fold rise (GMFR) relative to baseline of Immunoglobulin G (IgG) against meningococcal B strains, as measured by ELISA, at Day 30 following each vaccination and at 6 months after the last vaccination.
Measured: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Seroconversion rate (SCR) of Immunoglobulin G (IgG) against meningococcal B strains, as measured by ELISA, at Day 30 following each vaccination and at 6 months after the last vaccination.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start20 Mar 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria Meningitidis Serogroup BStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395739
- Sponsor's protocol ID
- C-104-003
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blinded, Positive-Controlled Clinical Trial to Assess the Safety and Immunogenicity of the Group B Meningococcal OMV Vaccine (DX-104) in Adults Aged 18 to 50 Years
- ClinicalTrials.gov ID
- NCT07395739
- Acronym / sponsor ID
- C-104-003
- Conditions
- Neisseria Meningitidis Serogroup B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks)Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.
Detailed description
A total of 30 healthy participants will be enrolled and randomized (2:1) to receive DX-104 or Bexsero® (multicomponent meningococcal group B vaccine). Participants in both the DX-104 and Bexsero® groups will receive three doses of intramuscular vaccination at Months 0, 1, and 6.
After all participants have completed the 6-month safety and immunogenicity observations following full vaccination, the trial will be concluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DX-104 | Experimental | Biological: Group B Meningococcal OMV VaccineParticipants in this arm will receive three doses of DX-104 at Months 0, 1, and 6. |
| Bexsero® | Active comparator | Biological: Bexsero®Participants in this arm will receive three doses of Bexsero® at Months 0, 1, and 6. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female participants aged 18 to 50 years (inclusive) at the time of screening, who can provide valid legal identification.
- Willing and able to give written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Willing and able to comply with all study procedures and available for the entire duration of the study follow-up.
- Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at screening.
- For female participants at least 1 of the following conditions must apply:
Key exclusion criteria (9 listed)
- 1. Oral temperature >37.5°C at screening or prior to vaccination 2. Previous vaccination with any Group B meningococcal vaccine (including GSK's Bexsero® or Pfizer's Trumenba®) or a history of invasive disease caused by Neisseria meningitidis.
- 3. Individuals with abnormal findings in pre-vaccination laboratory tests, vital signs, physical examination, or electrocardiogram (ECG) that are deemed clinically significant by the Investigator or delegate. 4. Known allergy or hypersensitivity to any component of the investigational vaccine, or a history of severe allergic reactions (including, but not limited to: anaphylaxis, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, Arthus reaction, dyspnea, angioneurotic edema, etc.).
- 5. Administration of any live-attenuated vaccine within 14 days (inclusive) prior to vaccination, or any other subunit, inactivated, or recombinant protein vaccine within 7 days (inclusive) before vaccination. 6. Acute illness or exacerbation of a chronic illness within 3 days prior to vaccination. 7. Use of antipyretics, analgesics, or anti-allergy medications within 24 hours prior to vaccination. 8. Long-term use of immunomodulators within 3 months prior to screening (e.g., systemic corticosteroids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day of prednisone or equivalent), or planned use during the study period. Note: Topical preparations (e.g., ointments, eye drops, inhalers, nasal sprays) are permitted.
- 9. Receipt of blood products and/or immunoglobulins within 3 months prior to vaccination, or planned administration during the study period. 10. Participants who have donated or lost more than 450 mL of blood within 30 days before the screening visit. 11. Participants with any severe underlying disease, congenital malformation, or ongoing medical condition that, in the judgment of the investigator or delegate, may pose a risk to the participant or interfere with the conduct, safety, or scientific validity of the trial. This includes, but is not limited to: active or latent tuberculosis (Mycobacterium tuberculosis), symptomatic or poorly controlled respiratory diseases such as asthma or chronic bronchitis, Down syndrome, thalassemia, heart disease, kidney disease, autoimmune disorders, atopic predisposition, Guillain-Barré syndrome, current skin diseases, etc.
- 12. Participants with encephalopathy, uncontrolled epilepsy, convulsions, other progressive neurological disorders, or a significant personal history of psychiatric disorders.
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 |
|---|---|---|
| Bexsero®Intramuscular injection; 0.5ml/pre-filled syringe. Administer the vaccine according to the 0, 1, 6-month schedule. | Biological | Bexsero® |
| Group B Meningococcal OMV VaccineAlso: DX-104Intramuscular injection; 0.5ml/vial. Administer the vaccine according to the 0, 1, 6-month schedule. | Biological | DX-104 |
Primary outcome
To assess the overall safety of DX-104
Time frame: Through study completion, an average of 1 year.
1. The incidence and severity of any AEs within 30 days after each vaccination. 2. The incidence and severity of any AEs within 30 minutes after each vaccination. 3. The incidence and severity of any solicited local and systemic AEs within 7 days after each vaccination. 4. The incidence and severity of any unsolicited AEs within 30 days after each vaccination. 5. The occurrence of clinically significant laboratory abnormalities on Day 3 after each vaccination. 6. The incidence of any serious adverse events (SAEs) from the first vaccination until 6 months after the last vaccination.
6 secondary outcomes
To evaluate the immunogenicity of DX-104
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Time frame: Through study completion, an average of 1 year.
To evaluate the immunogenicity of DX-104
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Neisseria Meningitidis Serogroup B
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
RecruitingPhase 4
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
Neisseria Meningitidis
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.
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 Bexsero® and Group B Meningococcal OMV Vaccine in people with Neisseria Meningitidis Serogroup B, run by Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks) at 1 site in Australia.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (（+86）021-50360201, clic@delonixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the overall safety of DX-104 (time frame: Through study completion, an average of 1 year.). 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 6 Apr 2026.