Methods
ICH
SECONDARY, POLIO, VIRAL SHEDDING, INFECTIOUS DISEASE
This was a single-center phase 1 randomized study to compare the safety, tolerability, and immunogenicity of a single dose of IPV with or without dmLT in healthy adults. The study was conducted at the Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Belgium following approval of the Antwerp University Hospital Ethics Committee. It was performed in accordance with the Declaration of Helsinki and the ICH GCP and guidelines of the Federal Agency for Medicines and Health Products (FAMHP), Belgium. The primary objectives were to evaluate and compare the safety of IPV + dmLT versus IPV alone and to compare the rate of fecal viral shedding throughout 28 days after a bOPV challenge dose at Day 29 post vaccination. The key secondary objectives were the evaluation and comparison of intestinal immune responses and the extent of fecal viral shedding following bOPV challenge.Eligible participants were healthy 18–45-year-old males or females with a history of complete IPV vaccination (at least three doses of IPV) who were available for the duration of the study. Main exclusion criteria were receipt of OPV at any time or IPV vaccination within the previous 5 years, having routine contact with children incompletely vaccinated against polio, i.e., those under 6 months of age, or any known conditions that might interfere with immune responses. IPV or IPV + dmLT were administered intramuscularly on Day 1 to groups of 30 participants each, in a blinded manner. A positive control group (unblinded) was included, composed of 20 adults who received bOPV. A challenge dose of bOPV was given to all participants on Day 29. Eight participants per day (the maximum capacity of the study site) were randomized in a 3:3:2 ratio to one of the three treatment groups, IPV, IPV + dmLT, and bOPV, using a permuted-block design generated and maintained by the Statistical Data Coordinating Center (SDCC) at The Emmes Company, LLC (Emmes). Subsets of 10 participants per group, one per group per day, were randomly selected for assessment of antibody secreting cells (ASC) α