Safety and Immune Response of Two-Dose H5N1 Influenza Vaccine in Adult Organ Transplant Patients

What this Trial Is About

Researchers are evaluating the safety and immune response of a two-dose regimen of the AS03-adjuvanted inactivated H5N1 influenza vaccine in adult organ transplant recipients. This study is important because transplant patients are at higher risk for serious infection from influenza, especially during outbreaks of highly pathogenic strains like H5N1. The study aims to generate data on vaccine effectiveness in this vulnerable group, which currently lacks immunogenicity information for H5Nx vaccines. Participants will be randomly assigned to receive either two doses of the H5N1 vaccine or placebo normal saline given intramuscularly in the deltoid muscle, three weeks apart. The study is double-blind and placebo-controlled, enrolling 120 stable organ transplant recipients. Blood samples will be collected at baseline, 3 weeks, and 6 weeks to measure immune responses, including antibody and cellular immunity. A subset of 60 participants will have additional immune cell analyses. Participants will be monitored for side effects for 7 days after each dose and followed for 6 months for safety and long-term immune response. Throughout the study, participants will undergo blood tests to assess immune responses and will be closely observed for adverse events, including any signs of transplant rejection or influenza-like illness. The main outcome is the level of protection and immune response 6 weeks after the first dose. Safety and durability of immunity will be evaluated up to 6 months post-vaccination. The total study duration includes vaccination, monitoring, and follow-up visits over this time frame to assess both short- and long-term effects of the vaccine in transplant recipients.

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)