Dynavax Technologies has dosed the first subject in a Phase I/II clinical trial of Z-1018, an investigational vaccine aimed at preventing shingles, also known as herpes zoster.
The active-controlled, randomised, dose escalation, multi-centre trial is anticipated to enrol around 440 healthy adults aged 50 to 69 years across multiple sites in Australia.
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It will assess the safety, tolerability, and immunogenicity of Z-1018 compared to the existing shingles vaccine, Shingrix.
One of the main goals is to determine the optimal dose of the glycoprotein E (gE) protein and the most effective dosing schedule for future clinical development.
Additionally, the study will help in validating a patient-reported outcome measurement tool.
This is intended to differentiate Z-1018 based on tolerability and to support potential claims on the vaccine’s label.
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By GlobalDataDynavax expects to release the immunogenicity and safety data in the second half of next year, which will include a comparative analysis of CD4+ T-cells after the second vaccine dose.
Dynavax chief medical officer Rob Janssen said: “We believe there is an opportunity to develop an improved shingles vaccine with a significantly better tolerability profile compared to the market-leading shingles vaccine.
“One of the unique advantages of our vaccine candidate is CpG 1018 adjuvant’s established safety and tolerability profile, combined with its ability to induce strong CD4+ T-cell responses, which are thought to be critical in preventing the reactivation of the herpes zoster virus.”
In September 2022, the company dosed the first participant in a Phase II trial of a recombinant plague vaccine, which includes the CpG 1018 adjuvant.
