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NCT Number: NCT07557602

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Q-Pharm Pty Ltd/Nucleus Network Pty Ltd, Herston, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VXCO-102

Biological

Sterile liquid for injection

Placebo

Biological

0.9% sodium chloride (BP grade)

Primary outcomes

  1. Number of Participants with Solicited Local and Systemic Reactions

    Time frame: 7 days after each product administration

  2. Number of Participants with Unsolicited Adverse Events

    Time frame: Up to 28 days after each product administration

  3. 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)

Secondary outcomes

  1. Rate of neutralizing antibody response

    Time frame: Day 1 and 85

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Chang

CONTACT

[email protected]

(+61) 3 8593 9801

Sponsors and collaborators

Lead sponsor

Vaccine Company, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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