Phase 2b Study to Evaluate Immune Response and Safety of Hecolin Vaccine in HIV Positive and Negative Adults and Healthy Children Aged 2 to 45 Years

What this Trial Is About

Researchers are evaluating the immune response and safety of the Hecolin4 recombinant hepatitis E vaccine in healthy children and adults, including those with and without HIV. The study aims to show that the vaccines immune response in children aged 2 to 17 years is not worse than in healthy adults aged 18 to 45 years. It also compares immune responses between HIV positive and negative adults and assesses safety across different age groups. Participants receive the vaccine or placebo through intramuscular injections according to their age group and HIV status. Adults 18-45 years receive three doses at 0, 1, and 6 months. Children and adolescents are divided into groups receiving either three doses, two doses, or placebo on similar schedules. Blood samples are collected at multiple timepoints before and after vaccination to measure immune response and safety markers. Participants are monitored closely at the study site after each injection for immediate reactions and keep diary cards to record side effects for 7 days. Safety data, including serious and medically attended adverse events, are collected throughout the study. The primary outcome is the rate of immune response measured 4 weeks after the third dose. The study includes follow-up blood collections for up to 2 years to assess long-term immune responses.

Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children