mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VXCO-102, Placebo.
- Who it may be relevant to
- Registry conditions: EBV. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
This is an adaptive design Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.
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.
Interventions
- Biological VXCO-102
Sterile liquid for injection - Biological Placebo
0.9% sodium chloride (BP grade)
Primary outcome measures
- Number of Participants with Solicited Local and Systemic Reactions [Time frame: 7 days after each product administration]
- Number of Participants with Unsolicited Adverse Events [Time frame: 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)]
Secondary outcome measures (1)
- Rate of neutralizing antibody response [Time frame: Day 1 and 85]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Australia · 2 centers
- Q-Pharm Pty Ltd/Nucleus Network Pty Ltd — Herston
- Nucleus Network Pty Ltd — Melbourne
Identifiers
NCT: NCT07557602 · VC103