Meningococcal conjugate vaccine for healthy adults aged 19–55

Multicenter, Randomized, Subject/Evaluator Blind, Active Control, Phase II/III Clinical Trial to Assess Immunogenicity and Safety of EG-MCV4 Meningococcal (Groups A, C, W-135, and Y) Conjugated Vaccines

This will test a single dose of the EG-MCV4 meningococcal conjugate vaccine to see if it produces protective antibodies and is safe in healthy adults aged 19 to 55.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 1123 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: EyeGene Inc. (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT07204457 on ClinicalTrials.gov

What this trial studies

This Phase 2/3 interventional trial gives a single dose of the investigational EG-MCV4 meningococcal conjugate vaccine to healthy adults aged 19–55, with Menveo included as a comparator. Eligible participants provide informed consent, attend scheduled in-person visits at the study site, and are contacted by phone for follow-up. The study collects blood samples to measure antibody responses to meningococcal groups A, C, W-135, and Y and records adverse events to monitor safety. Outcomes will compare immunogenicity and safety signals between EG-MCV4 and the licensed comparator.

Who should consider this trial

Good fit: Healthy adults aged 19–55 who have not previously received a meningococcal vaccine and can attend all scheduled visits and follow-up contacts.

Not a fit: People with prior meningococcal disease, recent contact with an infected person, recent or planned vaccinations within the exclusion windows, recent or chronic infections, or known hepatitis B or C are excluded and unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, EG-MCV4 could provide protection against meningococcal groups A, C, W-135, and Y with a safety profile similar to licensed conjugate vaccines.

How similar studies have performed: Licensed meningococcal conjugate vaccines such as Menveo have demonstrated good immunogenicity and safety in adults, so this approach builds on established vaccine technology.

Eligibility criteria

Inclusion Criteria:

* Healthy males and females aged 19 to 55 years.
* Individuals who have been fully informed about the clinical trial, understand the details, and voluntarily agree to participate by providing written informed consent.
* Individuals who are available for all scheduled visits, including phone calls and in-person appointments, for the duration of the study.

Exclusion Criteria:

* History of prior disease caused by N. meningitidis.
* Contact with a person infected with N. meningitidis within 60 days of screening.
* Prior receipt of a meningococcal vaccine or a vaccine containing a meningococcal antigen.
* History of or planned vaccination with any other vaccine within 4 weeks before or after administration of the investigational product.
* History of fever (≥ 38°C) within 3 days of screening, or a history of a significant acute infectious disease within 7 days of screening, or a chronic infectious disease within 4 weeks of screening.
* History of Hepatitis B or C at the time of screening.
* Presence of any significant acute, chronic, or progressive disease that, in the opinion of the investigator, could interfere with the conduct or completion of the study.
* History of malignancy or high-risk malignant disease within 5 years before the investigational product administration.
* History of epilepsy, progressive neurological disease, or Guillain-Barré Syndrome.
* History of anaphylaxis.
* History of systemic urticaria within 5 years of the investigational product administration.
* Hypersensitivity to the active substance, diphtheria toxoid (CRM197), or any other excipient, or a history of a life-threatening reaction to a vaccine containing similar components.
* Hypersensitivity to the investigational vaccine, any of its components, or latex.
* History of any therapy that could affect the immune system within 6 months of screening.
* History of immunodeficiency disease, or a family history of such a disease.
* Receipt of any parenteral immunoglobulin preparation, blood product, or plasma derivatives within 90 days of screening, or planned administration during the study period.
* History of platelet-related or hemorrhagic disorders or a history of excessive bleeding or bruising after intramuscular injection or venipuncture.
* Current treatment with anticoagulants or new antiplatelet agents.
* History of organ or bone marrow transplantation.
* Suspected history of drug or alcohol abuse within 1 year before the investigational product administration.
* Individuals unwilling to use a medically acceptable method of contraception for the duration of the clinical trial.
* Pregnant or lactating women.
* Receipt or planned receipt/application of another investigational drug or medical device within 6 months prior to study participation.
* Presence of a significant abnormality on a screening test, or any other reason that, in the opinion of the investigator, makes the individual unsuitable for the study.

Where this trial is running

Seoul

• The Catholic University of Eunpyeong St.Mary's Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Jooyoung Park

Conditions Meningococcal Infections; Meningococcal Vaccines; Vaccines, Conjugate; Bacterial Vaccines; Vaccines; Bacterial Infections; Meningococcal Disease; Neiseriaceae Infections