EBV
Conditions
Keywords
EBV, vaccine, mRNA, first in human, Epstein-Barr virus
Brief summary
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
BIOLOGICALVXCO-102
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride (BP grade)
Sponsors
Vaccine Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Rate of neutralizing antibody response | Day 1 and 85 |
Countries
Australia
Contacts
CONTACTChristina Chang
Outcome results
None listed