Dynavax Presents Positive Topline Data from Part 1 of Phase 1/2 Trial for Shingles Vaccine Candidate at IDWeek 2025 and Announces Initiation of Part 2 of Trial

Core Insights - Dynavax Technologies Corporation has presented positive topline data from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, and has initiated Part 2 of the trial to evaluate Z-1018 against Shingrix in older adults [1][3] Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, including HEPLISAV-B for hepatitis B and the CpG 1018 adjuvant used in various vaccines [8] Clinical Trial Details - Part 1 of the Phase 1/2 trial was a randomized, observer-blinded, active-controlled, dose escalation study assessing the safety, tolerability, and immunogenicity of Z-1018 in healthy adults aged 50 to 69 years, evaluating three different dose levels of gE antigen and two adjuvant formulations [2][5] - The key safety endpoint was solicited local and systemic post-injection reactions measured for up to seven days post-injection, while key immunogenicity endpoints included vaccine response rates for anti-gE IgG antibodies and gE-specific CD4+ T cells [2] Part 2 Trial Initiation - Part 2 of the trial has been initiated, enrolling approximately 324 healthy adults aged 70 years and older, aimed at further characterizing immunogenicity, safety, and tolerability of Z-1018 compared to Shingrix [3][6] - The company anticipates reporting topline immunogenicity and safety data from Part 2 in the second half of 2026 [3] Vaccine Performance - Z-1018 demonstrated comparable antibody and CD4+ T-cell responses to Shingrix with a favorable tolerability profile, showing robust polyfunctional CD4+ T-cell responses [5][6] - The formulation selected for advancement in Part 2 consists of 100 mcg gE adjuvanted with CpG 1018 plus alum, administered at 0 and 8 weeks [6][7] Shingles Background - Shingles, caused by the reactivation of the varicella-zoster virus, affects approximately 1 in 3 people in their lifetime and can lead to serious complications, particularly in older adults [4]