Abstracts

Rationale: The incidence of tuberculosis remains high in Japan (14/100,000/year). To prevent tuberculosis infection in early childhood, Bacille de Calmette et Guérin (BCG) live vaccine is administered to all infants in Japan. In April 2013, the timing of BCG vaccination was changed from 3 months of age to 5 to 8 months of age. Because of the close timing of BCG and the onset of West syndrome (WS), physicians are afraid of severe BCG infection due to ACTH-induced immunosuppression. However, delaying ACTH therapy is a risk factor for poor developmental outcomes. It is not clear how long we should wait to start ACTH therapy after BCG vaccination. We conducted a retrospective study of the interval between BCG and ACTH therapy in patients with WS to clarify the safety of ACTH therapy after BCG vaccination. Methods: We investigated 21 patients with WS who received ACTH therapy at Nagoya University Hospital between 2005 and 2018. The patients met the following inclusion criteria: 1) etiology unknown at the onset of WS; 2) no history of other seizure types before the onset of WS; 3) age between 3 and 11 months at the first ACTH therapy; and 4) BCG vaccination preceded ACTH therapy. We retrospectively collected the information on age at onset of WS, date of BCG vaccination, interval between BCG and initiation of ACTH therapy, and adverse events related to BCG. Results: The interval between BCG vaccination and ACTH therapy ranged from 14 to 168 (median 74) days. ACTH therapy was started within 60 (median 39.5, range 14-60) days after BCG vaccination in eight patients (early ACTH group). No adverse events related to BCG were observed in any patient. Comparing 16 patients given BCG vaccination before April 2013 and five patients after this, the numbers of patients in the early ACTH group and the interval between BCG vaccination and ACTH therapy were six (38%) and two (40%), and 14-164 (median 69.5) and 33-168 (median 119) days, respectively. Conclusions: There were no adverse events of BCG vaccination in patients who underwent ACTH therapy after BCG. This suggests that ACTH therapy can be used safely after BCG vaccination, although the number of patients in this study was small. The interval between BCG vaccination and ACTH therapy was slightly longer after the change in the timing of BCG vaccination. The longer interval may be due to the exclusion of patients with early onset WS after the change in BCG timing, or concern of physicians over the adverse events of BCG. Funding: No funding