The shingles vaccine market has long been dominated by a single product: Shingrix. But Dynavax Technologies is looking to change that. The company just reported positive topline data from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate designed to rival – and potentially outperform – the current standard of care.
Key Takeaways from the Study
- Head-to-head comparison: Z-1018 was tested directly against Shingrix in adults aged 50–69.
- Immune response: Z-1018 showed antibody and T-cell responses on par with Shingrix.
- 100% antibody response rate vs. 96.9% with Shingrix
- 89.7% T-cell response vs. 93.5% with Shingrix
- Composite immune response: essentially equivalent between both vaccines. - Tolerability advantage: Participants reported fewer side effects with Z-1018.
- Local reactions (pain, redness, swelling): 12.5% with Z-1018 vs. 52.6% with Shingrix
- Systemic reactions (fever, fatigue, aches): 27.5% with Z-1018 vs. 63.2% with Shingrix
Why This Matters
Shingles is a painful condition caused by the reactivation of the chickenpox virus. It affects 1 in 3 people in their lifetime and risk rises sharply with age. Shingrix has been the go-to solution, but it is also known for its high reactogenicity (strong side effects), which discourages some patients from completing the two-dose schedule.
Dynavax is betting that Z-1018, with comparable protection and a more favorable tolerability profile, could open the door for broader vaccination uptake.
What’s Next for Z-1018?
Dynavax has selected its lead formulation – a 100 mcg dose with CpG 1018 plus alum adjuvant, given on an 8-week schedule – to move forward.
- Part 2 of the trial will enroll adults aged 70 and older, a group at highest risk for shingles.
- This phase will generate proof-of-concept data and further de-risk the program before a pivotal Phase 3 trial.
- If successful, Dynavax could bring a best-in-class shingles vaccine to a multi-billion-dollar market currently dominated by one player.
The Bigger Picture
Dynavax is already known for HEPLISAV-B, its hepatitis B vaccine, and its proprietary CpG 1018 adjuvant, used in multiple vaccines worldwide. With Z-1018, the company is aiming to replicate that success in another high-value market.
“We met our goal for this study. Z-1018 shows immune responses comparable to Shingrix, with fewer side effects,” said Ryan Spencer, CEO of Dynavax. “This positions us to advance into older populations and, ultimately, late-stage development.”
Bottom Line
Dynavax’s Z-1018 could emerge as a serious challenger to Shingrix, offering patients the same protection with a smoother experience. If Part 2 confirms these findings in older adults, the race for shingles vaccine dominance may finally have a new contender.
