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.
Go deeper with GlobalData
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
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.
