Safety and immunogenicity of the respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVPreF3 OA) in Asian older adults (≥60 years of age)

초록

Background and Aims: Despite the significant burden of RSV disease in older adults (OAs), there has been no prophylactic therapy in this population. RSVPreF3 OA was recently licensed in the US and Europe. We investigated whether the safety and immunogenicity of RSVPreF3 OA in Asian OAs are in line with those in non-Asian OAs. Methods: Our descriptive analysis was performed by pooling data for Asian and non-Asian OAs from two phase 3, randomized studies: the pivotal placebo-controlled efficacy study AReSVi-006 (NCT04886596; in Japan/Korea), and the immunogenicity study AReSVi-004 (NCT04732871; in Japan/Taiwan). These studies were selected because AReSVi-006 was the main source for safety assessment and AReSVi-004 was the main source for immunogenicity assessment post-vaccination with one-dose of RSVPreF3 OA. Results: In the overall study population, the efficacy of a single dose of RSVPreF3 OA against RSV-related lower respiratory tract disease (LRTD) was 82.6%. Due to the low number of RSV-LRTD cases in Asian OAs (1 case), efficacy data for Asian participants were inconclusive. Although more solicited reactions were observed in Asian versus non-Asian participants, the overall safety profile of RSVPreF3 OA was similar in both populations and clinically acceptable (Table). In the AReSVi-004 study, humoral and cellular immune responses elicited by RSVPreF3 OA in Asian and non-Asian OAs were robust, comparable (Table) and remained above baseline up to 6 months post-vaccination. Conclusions: Overall, a single dose of RSVPreF3 OA vaccine had an acceptable safety profile and was immunogenic in Asian OAs; the results were comparable to those for non-Asian OAs.