Study on Safety and Immune Response of Two Doses of Recombinant Herpes Zoster Vaccine in Healthy Adults Aged 40 and Older

What this Trial Is About

Researchers are evaluating the safety and immune response of two doses of a recombinant herpes zoster vaccine RHZV in healthy adults aged 40 and older. The study includes two parts Substudy A Phase I and Substudy B Phase II. It aims to assess different vaccine candidates, including dose levels, compared with the approved shingles vaccine and controls, to better understand their effects in various age groups. In Substudy A, participants aged 40-49 and 50 will receive one of two RHZV candidates, the approved shingles vaccine, adjuvant controls, or saline via intramuscular injection on days 0 and 60. This phase includes a 12-month safety follow-up, totaling about 14 months of involvement. Substudy B includes age groups 40-49, 50-69, and 70, using similar vaccination schedules and treatments. Some groups will continue to be monitored for up to 2 years to study the persistence of immunity. Participants will undergo regular safety assessments including monitoring immediate, solicited, unsolicited, and serious adverse events after vaccination. Researchers will measure antibody levels and immune response at multiple timepoints up to two years, using blood tests for specific antibodies. Study visits will include vaccinations, follow-ups, and immune response evaluations, helping to understand the vaccines safety and the bodys lasting immune reaction.

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals