mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults

April 22, 2026 updated by: Vaccine Company, Inc.

A Phase 1, Dose Escalation, Placebo-Controlled, Adaptive-Design Study to Evaluate the Safety and Immunogenicity of VXCO-102, a mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults

This is an adaptive design Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This first-in-human, dose-escalation Phase 1 trial evaluates the safety, tolerability, and immunogenicity of VXCO-102 in healthy young adults across multiple sites in Australia.

Part A will enroll ~45 participants aged 18-25. After sentinel safety review in each dose cohort, participants will be randomized to receive VXCO-102 or placebo, with a booster at Week 8. If Part A results are favorable, the study may expand to Part B to further assess safety, reactogenicity, and immunogenicity.

All participants will undergo ongoing safety monitoring and immune response assessments through clinical evaluations, sample collection, and participant reporting.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Q-Pharm Pty Ltd/Nucleus Network Pty Ltd
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Network Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 18 to 25 years, inclusive
  • Healthy per medical assessment based on self-reported medical history, physical examination, vital signs, and laboratory assessment

Exclusion Criteria:

  • Self-reported or medically-documented significant medical or psychiatric condition that per medical assessment could interfere with study participation
  • Likely or confirmed myocarditis or pericarditis
  • Prior receipt of an investigational EBV vaccine
  • Prior receipt of a licensed vaccine within 56 days prior to Day 1
  • Received more than 10 days of any systemic immunosuppressants or cytotoxic medications within 56 days prior to Day 1, any within 14 days prior to Day 1, or will need immunosuppressants at any time during the study.
  • For participants of childbearing potential: pregnant, breastfeeding or planning to become pregnant during the study

Note: Other inclusion and exclusion criteria apply.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Dose 1 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
Biological: VXCO-102
Sterile liquid for injection
Experimental: Group 2
Dose 2 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
Biological: VXCO-102
Sterile liquid for injection
Experimental: Group 3
Dose 3 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
Biological: VXCO-102
Sterile liquid for injection
Placebo Comparator: Group 4
Sodium Chloride administered IM by needle and syringe at Day 1 and Week 8
Biological: Placebo
0.9% sodium chloride (BP grade)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Solicited Local and Systemic Reactions
Time Frame: 7 days after each product administration
7 days after each product administration
Number of Participants with Unsolicited Adverse Events
Time Frame: Up to 28 days after each product administration
Up to 28 days after each product administration
Number of Participants with Serious Adverse Events (SAEs) including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events of Special Interest (AESIs)
Time Frame: Day 1 to end of study (Day 357)
Day 1 to end of study (Day 357)

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of neutralizing antibody response
Time Frame: Day 1 and 85
Day 1 and 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaccine Company, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 4, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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