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This is an adaptive design Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Dose 1 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 |
|
| Group 2 | Experimental | Dose 2 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 |
|
| Group 3 | Experimental | Dose 3 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 |
|
| Group 4 | Placebo Comparator | Sodium Chloride administered IM by needle and syringe at Day 1 and Week 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VXCO-102 | Biological | Sterile liquid for injection |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of neutralizing antibody response | Day 1 and 85 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Chang | Contact | (+61) 3 8593 9801 | melbourne@nucleusnetwork.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd/Nucleus Network Pty Ltd | Herston | Queensland | 4006 | Australia | ||
| Nucleus Network Pty Ltd |
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Placebo | Biological | 0.9% sodium chloride (BP grade) |
|
| Melbourne |
| Victoria |
| 3004 |
| Australia |
| D014412 |
| Tumor Virus Infections |