Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults

Launched by DYNAVAX TECHNOLOGIES CORPORATION · Aug 22, 2024

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ClinConnect Summary

This clinical trial is investigating a new vaccine called Z-1018, which aims to protect against shingles, also known as herpes zoster. The goal is to see how safe this investigational vaccine is and how well it works compared to an existing shingles vaccine called Shingrix®. The study will involve about 440 healthy adults aged between 50 and 69 years. To participate, individuals must be in good health, meaning they have no serious medical issues, and they should not have had shingles or received any shingles vaccines in the past.

Participants in this study can expect to receive two doses of the vaccine and will be monitored closely for any side effects or reactions. They will also need to attend several scheduled visits to help researchers gather important information. It's important to note that certain people, such as those with a history of autoimmune diseases or certain medical conditions, will not be eligible for this trial. If you or a loved one meet the criteria and are interested in participating, this could be a valuable opportunity to contribute to research that helps improve shingles prevention.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A subject must meet all of the following criteria to be eligible for enrollment (defined as receiving any study vaccine) in the study:
• • 1. Male or female, 50 to 69 years of age
• • 2. Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
• • 3. Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
• • 4. Seronegative for human immunodeficiency virus (HIV)
• Exclusion Criteria:
• A subject with any 1 of the following criteria is not eligible for enrollment (defined as receiving any study vaccine) in the study:
• • 1. History of HZ
• • 2. Previous vaccination against varicella or HZ
• • 3. If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
• • 4. Known history of HIV (HIV 1/2 antibodies)
• • 5. Has a history of sensitivity to any component of study vaccines
• • 6. Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period
• • 7. Has received the following prior to the first injection
• • 14 days: any non live vaccine
• * 28 days:
• • Any live vaccine, including a COVID-19 vaccine
• • Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
• • Granulocyte or granulocyte-macrophage colony-stimulating factor
• • Any other investigational medicinal agent, including a COVID-19 vaccine
• • 8. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
• • 9. Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
• • 10. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• • 11. History of autoimmune disease