Phase I Study to Assess Safety and Immune Response of CVI-VZV-001 Vaccine Compared to Shingrix in Healthy Adults Aged 50 to 64 Years

What this Trial Is About

Researchers are evaluating the safety and immune response of an investigational vaccine called CVI-VZV-001 for preventing herpes zoster shingles in healthy adults aged 50 to 64 years. This Phase I, open-label study compares different doses of CVI-VZV-001 with an active control vaccine called Shingrix. The study aims to explore how well the vaccine is tolerated and how it stimulates the immune system. Participants will receive two intramuscular injections at the start of the study and eight weeks later. Four groups are involved three different dose levels of CVI-VZV-001 0.37 mL, 0.50 mL, and 0.75 mL and one group receiving the Shingrix vaccine 0.50 mL. Each participant receives two doses during the study period. During the study, participants will be monitored closely for immediate reactions within 30 minutes after vaccination and for local and systemic side effects for six days after each vaccination. Unsolicited symptoms will be tracked up to four weeks after the second dose, with serious and medically attended adverse events monitored for up to 48 weeks. Researchers will assess immune responses before and after vaccinations, including at 4, 24, and 48 weeks post-second dose, using laboratory tests and physical exams to evaluate safety and immune activity.

Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above