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Safety and Immunogenicity of Group B Meningococcal OMV Vaccine (DX-104) in Adults

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Study Aim

This study aims to evaluate the safety of a new Group B Meningococcal OMV vaccine (DX-104) in adults, by monitoring any adverse events or reactions within specific timeframes after vaccination.

What is being tested

Bexsero®

+ Group B Meningococcal OMV Vaccine

Biological
Who is being recruted

From 18 to 50 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorShanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks)
Study ContactProject Manager
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 24, 2026

Actual date on which the first participant was enrolled.

This clinical trial is a Phase I study that aims to evaluate the safety and immune response of a new vaccine called DX-104. This vaccine is designed to prevent Group B Meningococcal disease in adults aged 18 to 50 years. The study involves 30 healthy participants and is important as it could potentially lead to a new way to protect against this serious disease, addressing a significant unmet need in public health. Participants in this trial will be randomly assigned to receive either DX-104 or an existing vaccine called Bexsero®. Both groups will receive three doses of their respective vaccines, given as intramuscular injections at Months 0, 1, and 6. The trial will conclude once all participants have completed a 6-month observation period after full vaccination. During this period, the study will assess the overall safety of DX-104 by monitoring any adverse events within 30 days and 30 minutes after each vaccination, as well as any significant laboratory abnormalities and serious adverse events throughout the study duration.

Official TitleA 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
NCT07395739
Principal SponsorShanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks)
Study ContactProject Manager
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Male participants are able to participate if they: i) 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.
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 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.
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11 exclusion criteria prevent from participating
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.
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.
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.).
Participants with encephalopathy, uncontrolled epilepsy, convulsions, other progressive neurological disorders, or a significant personal history of psychiatric disorders.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Participants in this arm will receive three doses of Bexsero® at Months 0, 1, and 6.

Group II

Experimental
Participants in this arm will receive three doses of DX-104 at Months 0, 1, and 6.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Linear Early Phase Limited

Perth, AustraliaOpen Linear Early Phase Limited in Google Maps
Recruiting soonOne Study Center
Safety and Immunogenicity of Group B Meningococcal OMV Vaccine (DX-104) in Adults | PatLynk