Dynavax Technologies Corporation (Nasdaq: DVAX), a California-based commercial-stage biopharmaceutical company, announced on Thursday that it has dosed its first participant in a phase 1/2 clinical trial assessing Z-1018, the company's investigational vaccine candidate intended for the prevention of shingles (herpes zoster).
The Phase 1/2 randomised, active-controlled, dose escalation, multicentre trial is expected to enrol around 440 healthy adults aged 50 to 69 years at trial sites in Australia. It is intended to assess the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix.
Key objectives of the trial include selecting the optimal glycoprotein E (gE) protein dose level and dosing schedule for further clinical development. The Phase 1/2 trial will be used to support validation of a Patient Reported Outcome measurement tool to differentiate Z-1018 on tolerability and to support potential label claims. Dynavax anticipates reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4+ T-cells one month after the second of two vaccine doses.
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