At IDWeek, the company reported promising phase 1/2 trial results for its shingles vaccine candidate Z-1018, demonstrating strong immune responses and favorable tolerability.
During a late-breaker session at IDWeek, Dynavax Technologies announced its positive topline results from part 1 of its phase 1/2 clinical trial evaluating Z-1018, the company’s novel shingles vaccine candidate. The company also confirmed that part 2 of the study—directly comparing Z-1018 with Shingrix in older adults—has officially begun.
“Z-1018 has the potential to deliver best-in-class performance by combining robust immunogenicity with a differentiated tolerability profile. The new phase aims to confirm these advantages in adults aged 70 and older, who are at the highest risk for shingles," Dynavax Chief Medical Officer Robert Janssen, MD, said in a statement.
Part 1 of the randomized, observer-blinded, active-controlled trial evaluated multiple dose levels and adjuvant formulations of Z-1018 in adults aged 50–69 years. Results showed that Z-1018, adjuvanted with CpG 1018 (with or without alum), produced strong antibody and T-cell responses comparable to Shingrix, while maintaining favorable tolerability. Notably, Z-1018 induced a high proportion of polyfunctional CD4+ T-cell responses, indicating a robust and broad cellular immune response.
Z-1018 generated antibody and T-cell responses comparable to Shingrix, suggesting promising efficacy potential.
Participants receiving Z-1018 experienced a differentiated and well-tolerated safety profile across dose levels.
The vaccine’s optimal formulation is advancing to a larger Phase 1/2 trial in older adults, with results expected in late 2026.
Based on these findings, Dynavax selected the formulation containing 100 mcg of gE adjuvanted with CpG 1018 plus alum, administered at 0 and 8 weeks, to advance into Part 2. This next phase will enroll approximately 324 healthy adults aged 70 and older across Australia and New Zealand to further assess safety, tolerability, and immunogenicity, including demonstrating non-inferiority to Shingrix.
Dynavax expects to report topline results from part 2 in the second half of 2026.
Z-1018 is an investigational non-live, recombinant subunit vaccine in development for the prevention of shingles in adults aged 50 and over. It combines an antigen, glycoprotein E, with Dynavax's proprietary adjuvant system, CpG 1018, and alum and may help overcome the natural age-related decline in responses to immunization that contributes to the challenge of protecting adults aged 50 and over from shingles.
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