Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating the safety and immune response of meningococcal and pneumococcal vaccines in adults living with HIV who are receiving antiretroviral treatment. This trial is a single-center, randomized controlled study designed to compare two different vaccination regimens to better understand their effects on this population. The study is investigator-initiated and focuses on long-term immunogenicity and safety outcomes. Participants are randomly assigned to receive either a two-dose regimen of Menveo (a conjugate vaccine against meningococcal serogroups ACWY) combined with Bexsero (a vaccine against meningococcal serogroup B) at day 0 and day 60, or a prime-boost regimen of Prevenar13 (a 13-valent pneumococcal conjugate vaccine) and Pneumovax23 (a 23-valent pneumococcal polysaccharide vaccine) given at day 0 and day 60. A crossover between groups occurs at day 90. All participants follow the same follow-up schedule including collection of plasma, pharyngeal swabs, and recording of any adverse events. Throughout the study, blood samples are taken at 30 days post-vaccination and yearly for five years to measure immune responses. Researchers will monitor immediate, short-term, and long-term side effects after vaccination, as well as bacterial carriage rates at baseline and day 30. The total duration of participant involvement includes the initial vaccinations, crossover, and follow-up visits to assess vaccine safety and effectiveness over time.

Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV