mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
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
1 other identifier
interventional
45
1 country
2
Brief Summary
This is an adaptive design Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedStudy Start
First participant enrolled
May 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 29, 2026
April 1, 2026
1.3 years
April 22, 2026
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants with Solicited Local and Systemic Reactions
7 days after each product administration
Number of Participants with Unsolicited Adverse Events
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)
Day 1 to end of study (Day 357)
Secondary Outcomes (1)
Rate of neutralizing antibody response
Day 1 and 85
Study Arms (4)
Group 1
EXPERIMENTALDose 1 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
Group 2
EXPERIMENTALDose 2 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
Group 3
EXPERIMENTALDose 3 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
Group 4
PLACEBO COMPARATORSodium Chloride administered IM by needle and syringe at Day 1 and Week 8
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18 to 25 years, inclusive
- Healthy per medical assessment based on self-reported medical history, physical examination, vital signs, and laboratory assessment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Q-Pharm Pty Ltd/Nucleus Network Pty Ltd
Herston, Queensland, 4006, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2026
First Posted
April 29, 2026
Study Start
May 4, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share