Dynavax reports results from Phase 1 trial of shingles vaccine Z-1018

The Phase 1 clinical trial was designed to evaluate an investigational shingles vaccine Z-1018, utilizing different regimens of CpG 1018 adjuvant, with or without aluminum hydroxide. The trial compared Z-1018 arms versus the active comparator Shingrix. The company reported the following topline results, assessed at Week 12, and plans to submit an abstract for presentation at an upcoming medical meeting in the first half of 2023. Z-1018 demonstrated high antibody and CD4 positive T-cell vaccine response rates in all arms, which were similar to the comparator; Robust increases in CD4 positive T-cells were observed in all Z-1018 arms, although lower than the comparator; Total frequency of solicited systemic adverse events and local post-injection reactions were similar across the Z-1018 arms and lower than the comparator. The frequency of moderate and severe local post-injection reactions was 9% for Z-1018 arms compared to 37% for the comparator and the frequency of moderate and severe solicited systemic adverse events was 26% for Z-1018 arms and 43% for the comparator. Based on these initial data, the company intends to advance its shingles vaccine candidate with CpG 1018 adjuvant into a Phase 1-2 study in early 2024 to expand on these results and to evaluate various dose levels of Dynavax-manufactured gE protein.