Company Initiates Phase 1/2 Study for Investigational Shingles Vaccine

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Biopharmaceutical company, Dynavax, is comparing its investigational immunization against a FDA-approved vaccine.

woman getting a vaccine; image credit: unsplash

The main virus symptom of Shingles is characterized by a painful skin rash. This is known as postherpetic neuralgia (PHN).
image credit: unsplash

Emeryville, Ca-based, Dynavax Technologies, announced yesterday that they had dosed the first participant in the company’s phase 1/2 clinical trial for it’s Z-1018, the company's investigational vaccine candidate being developed for the prevention of shingles. Dynavax is evaluating the safety, tolerability, and immunogenicity of (herpes zoster), a debilitating disease caused by the varicella-zoster virus.1

The study is a randomized, active-controlled, dose escalation, multicenter trial, and is expected to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia, and will be compared to the FDA-approved shingles vaccine, Shingrix. 1

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 be used to support validation of a Patient Reported Outcome measurement tool to differentiate Z-1018 on tolerability and to support potential label claims. 1

"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. 1

Learn More: Watch a past interview with Janssen.

What You Need to Know

Investigational vaccine, Z-1018, is being developed to prevent shingles (herpes zoster), a painful disease caused by the varicella-zoster virus.

Z-1018’s CpG 1018 adjuvant has a safety profile and induces CD4+ T-cell responses.

Dynavax plans to report immunogenicity and safety data in 2025, including CD4+ T-cell comparison.

Shingles Incidence Rates and Symptoms
Shingles is a reactivation of a latent varicella-zoster virus, the same virus that causes childhood chickenpox, with attacks leading to potential complications including chronic pain. So, for anyone who contracted chickenpox, they can get shingles.

Shingles is not transmissible between people, but people who have shingles can spread the varicella-zoster virus to people who have never had chickenpox or the chickenpox vaccine, causing them to contract it. The virus is spread through direct contact with the rash or by breathing in virus particles that are in the air.

According to the Centers for Disease Control and Prevention (CDC), about 1 in 3 people in the US will develop shingles in their lifetime. People’s risk of having shingles increases as they age or if you have a weakened immune system. Most people who have shingles only have it one time. However, you can have shingles more than once.2

The main virus symptom is characterized by a painful skin rash. This is known as postherpetic neuralgia (PHN). Approximately 10% to 18% of people with herpes zoster will get PHN. CDC reports 1% to 4% of people with shingles go to the hospital for complications. This subset of patients are typically older adults and people with weakened or suppressed immune systems.2


What’s Next

Dynavax anticipates reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4+ T-cells 1 month after the second of two vaccine doses.

The company said in a statement that although there is an FDA-approved vaccines for shingles, there is an unmet medical need for a shingles vaccine with both high efficacy and improved tolerability.

“We believe there is an opportunity to develop an improved shingles vaccine with a significantly better tolerability profile compared to the market-leading shingles vaccine,” Janssen said. 1


References
1. Dynavax Initiates Phase 1/2 Study of Novel Shingles Vaccine Program. Dynavax press statement. June 27, 2024.Accessed June 28, 2024.
https://investors.dynavax.com/news-releases/news-release-details/dynavax-initiates-phase-12-study-novel-shingles-vaccine-program
2. Shingles (Herpes Zoster). CDC. April 12, 2024. Accessed June 28, 2024.
https://www.cdc.gov/shingles/data-research/index.html

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