Experiences of participant engagement from an African and Asian ancestry cohort during a clinical research study of lymph node responses to influenza immunisation in the United Kingdom

Background Despite the importance of diversity and inclusion for equity in health outcomes, ancestral diversity is underrepresented in clinical studies of human immunity and immunisation. The global population is incompletely represented in vaccine trials and in publicly available datasets of human tissue such as the Human Cell Atlas. LEGACY01 (ISRCTN13657999) was an experimental medicine study at NIHR Imperial Clinical Research Facility, London, UK, which focused on addressing this inequity by investigating influenza vaccine responses in the lymph nodes of an ethnically diverse cohort. Methods The study included participants with self-declared African or Asian ancestry. Participants in the second season cohort (2023–2024), were surveyed on their experiences during the study. Participants underwent fine needle aspiration (FNA) of axillary lymph nodes before and 5 (+/-2) days post vaccination with a seasonal influenza vaccine. Participants were asked about symptoms, called adverse events (AEs), related to FNA and whether they wanted to take part in a research experience questionnaire to assess overall satisfaction, willingness of participation and areas for improvement. Results Participants enrolled (n = 17) during the influenza season of 2023–2024 were from eight self-declared ethnicities. Adverse events related to FNA, including pain and bruising at the procedure site, were reported by 13/17 (76.5%) participants, but these were generally expected, transient and well-tolerated symptoms that did not negatively affect completion of the study or willingness for further procedures. In the survey, participants recorded that factors such as the friendliness of study staff and ease of process contributed to their positive research experience. 17/17 (100%) participants agreed or strongly agreed that they felt informed and comfortable with asking questions, believed staff treated them with respect and courtesy and were overall satisfied with the services provided. Using a Likert scale, 15/17 (88.2%) participants agreed or strongly agreed that they would consider participating in future studies. Conclusions The research conducted in LEGACY01, which included a minor biopsy procedure, met with an overwhelmingly positive response. Research participation by underserved communities can be successful through efforts to facilitate communication and comfort during the research experience and by highlighting the importance of diversity in research to potential participants. Trial registration number: ISRCTN13657999 Registration date: 09/09/2022