Dynavax Unveils Promising Trial Results for Shingles Vaccine
Dynavax Advances Shingles Vaccine Z-1018 After Positive Trial Data
Dynavax Technologies Corporation (NASDAQ: DVAX), a prominent player in the biopharmaceutical landscape, recently showcased encouraging topline data from part one of its Phase 1/2 clinical trial for Z-1018, a novel candidate designed to combat shingles. This advancement was highlighted during a key presentation at IDWeek 2025. In addition, the company has begun part two of the trial, which focuses on assessing Z-1018 against Shingrix in adults aged 70 years and older.
Key Findings from Phase 1 Trial
The initial phase of the trial was structured as a randomized, observer-blinded, active-controlled study that spanned multiple centers. It aimed to evaluate Z-1018's safety, tolerability, and immunogenicity in healthy adults aged 50 to 69. Participants were tested across different doses of gE antigen, with varying adjuvant combinations and dosing schedules. Researchers focused on crucial safety and immunogenicity endpoints to measure the vaccine's effectiveness.
Among the findings, Z-1018 demonstrated about the same antibody and CD4+ T-cell responses as Shingrix, signifying robust performance in immunogenicity. Safety assessments indicated favorable tolerability, with manageable side effects reported by participants.
Detailed Results and Highlights
At IDWeek, Dynavax presented a wealth of data supporting Z-1018’s strong performance. The vaccine produced high concentrations of anti-gE IgG antibodies and increased frequencies of CD4+ T cells, comparable to Shingrix. Notably, a significant portion of the T-cell responses were polyfunctional, which means they showed multiple activation markers indicative of a robust immune response.
- Z-1018, when adjuvanted with CpG 1018 (alone or paired with alum), exhibited promising tolerability and significant immune responses across dosage ranges.
- The targeted ratio of immunogenic response was achieved, aligning with the criteria set against Shingrix after the second dose.
- 100 mcg of gE adjuvanted with CpG 1018 plus alum was selected for advancement into part two of the Phase 1/2 trial.
Part 2 of the Trial Commences
The initiation of part two marks a significant milestone for Dynavax. This segment of the trial will encompass around 324 healthy adults aged 70 and older across various locations in Australia and New Zealand. It is designed to further explore immunogenicity, safety, and tolerability of Z-1018, confirming its effectiveness compared to Shingrix.
The expectations are high, with Dynavax planning to release topline data on immunogenicity and safety from this phase by the second half of 2026. This forward-thinking approach reflects the company's commitment to advancing vaccine development and addressing the needs of an aging population.
Understanding Shingles and Z-1018
Shingles, caused by the varicella-zoster virus, affects a significant portion of the population and tends to lead to more severe complications in older individuals. While existing vaccines like Shingrix have shown to be effective, there still exists a desire for increased access and improved tolerability in vaccines.
Z-1018 is a non-live, recombinant subunit vaccine that aims to provide durable protection for adults aged 50 and over against shingles. The combination of glycoprotein E with the specialized CpG 1018 adjuvant system may counteract the natural decline in immune responses seen with age.
About Dynavax Technologies
Dynavax is at the forefront of developing innovative vaccine solutions aimed at infectious diseases. The company’s offerings include HEPLISAV-B, an adjuvanted hepatitis B vaccine approved for adults, and CpG 1018, the adjuvant employed in its vaccines. With a strong pipeline and proven products, Dynavax continues to shape the landscape of vaccine technology.
Frequently Asked Questions
What are the main findings from the recent Dynavax trial?
The trial results indicate that Z-1018 shows promising immunogenicity and tolerability compared to the Shingrix vaccine.
Who is participating in Part 2 of the Z-1018 trial?
Part 2 involves approximately 324 healthy adults aged 70 years and older from Australia and New Zealand.
What is the goal of the ongoing Z-1018 study?
The study aims to establish Z-1018's safety and efficacy, confirming its advantages over Shingrix.
When will the results for Part 2 be available?
Dynavax expects to report topline immunogenicity and safety data for Part 2 in the latter half of 2026.
What is the significance of the CD4+ T-cell responses observed?
High CD4+ T-cell responses indicate a robust immune defense, which is crucial for effective vaccination against shingles.
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