Study on Immune Responses to Meningococcal B Vaccine in Healthy Adults Aged 18 to 50 Including Transgender and Cisgender Men and Women

What this Trial Is About

Researchers are investigating how sex and gender differences affect immune responses to vaccines by studying transgender and cisgender individuals. This study focuses on the immune reactions to the four-component meningococcal serogroup B 4CMenB Bexsero vaccine. It aims to understand how hormonal changes in transgender people, who retain their chromosomal sex but undergo gender-affirming hormone therapy, influence both humoral and cellular immune responses compared to cisgender individuals. Participants will receive two doses of the 4CMenB vaccine via intramuscular injections in the non-dominant upper arm, spaced one month apart. The study includes four groups of 30 individuals each cisgender men, cisgender women, transgender women, and transgender men. Transgender participants must have been on stable gender-affirming hormone therapy for at least six months. The vaccination process and immune response evaluation will take place over a set period following the first dose. During the study, participants will undergo medical evaluations including medical history and physical exams to confirm general health and eligibility. Immune responses, including antibody production and T cell activity, will be measured from the first vaccination to two months after the primary vaccination. The study monitors safety and compliance, requiring participants to attend follow-up visits and adhere to study procedures. The total participation duration covers vaccination and subsequent immune response assessment over several months.

Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons