Novel Shingles Vaccine Candidate Launches Phase 1/2 Study

Dynavax Technologies Corporation today announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of shingles (herpes zoster).

The Phase 1/2 randomized, active-controlled, dose escalation, multicenter trial is expected to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia and will evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to the Shingrix® vaccine.

Key objectives of the trial include selecting the optimal glycoprotein E (gE) protein dose level and dosing schedule for further clinical development. The Phase 1/2 trial will also support the validation of a Patient-Reported Outcome measurement tool to differentiate Z-1018 on tolerability and support potential label claims.

"We believe there is an opportunity to develop an improved shingles vaccine with a significantly better tolerability profile than the market-leading shingles vaccine. One of the unique advantages of our vaccine candidate is CpG 1018 adjuvant's established safety and tolerability profile, combined with its ability to induce strong CD4+ T-cell responses, which are thought to be critical in preventing the reactivation of the herpes zoster virus," said Rob Janssen, M.D., Chief Medical Officer of Dynavax, in a press release on June 27, 2024.

Dynavax anticipates reporting top-line immunogenicity and safety data in the second half of 2025, including comparing CD4+ T-cells one month after the second of two vaccine doses.

According to the U.S. CDC, shingles risk increases with age and in people with weakened immune systems. About 33% of people in the United States develop shingles at least once, and fewer than 100 people die of shingles each year.

As of June 2024, there are four approved shingles vaccines and several vaccine candidates conducting clinical research.