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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
45
Q-Pharm Pty Ltd/Nucleus Network Pty Ltd
Herston, Queensland, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
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)
Rate of neutralizing antibody response
Time frame: Day 1 and 85
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