2139. Immunogenicity, reactogenicity and safety of a Respiratory Syncytial Virus prefusion F (RSVPreF3) candidate vaccine co-administered with the seasonal quadrivalent influenza vaccine in older adults

Abstract

Background Respiratory syncytial virus (RSV) can cause severe respiratory disease in older adults (OAs). However, there is no approved vaccine against RSV disease in OAs. Co-administration of vaccines against RSV and influenza could be considered given their overlapping seasonality. Here, we assessed the immunogenicity, reactogenicity and safety of an RSV prefusion F Older Adult (RSVPreF3 OA) investigational vaccine when co-administered with the seasonal quadrivalent influenza vaccine (FLU-QIV) in OAs. Methods In this Phase 3, open-label, controlled, multi-country study (NCT04841577), OAs aged ≥ 60 years recruited in New Zealand, Panama and South Africa were randomized 1:1 to receive either RSVPreF3 OA and FLU-QIV simultaneously on day 1 (Co-Ad group), or FLU-QIV on day 1 and RSVPreF3 OA on day 31 (Control group). The co-primary objectives were to demonstrate the non-inferiority of i) RSVPreF3 OA in terms of RSV-A neutralizing antibody geometric mean titers (GMT) ratio and ii) FLU-QIV in terms of hemagglutinin inhibition antibody GMT ratio for each Flu strain when co-administered versus when administered alone. Blood samples were collected from all participants pre vaccination and 1 month post vaccination. Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) of the group GMT ratio (Control/Co-Ad) was ≤ 1.5. Secondary descriptive outcomes included reactogenicity and safety. Results 885 participants received at least 1 dose of the study interventions. Of these, 838 were included in the per protocol set at 1 month post vaccination. The demographic characteristics of the participants were similar across groups. The study co-primary objectives were met; for both vaccines, the UL of the 95% CI of the GMT ratio was ≤ 1.5 (Table 1). The observed safety events were balanced between Co-Ad and Control groups (Table 2). The reactogenicity profile of the Co-ad group compared with the Control group was driven by the RSVPreF3 OA investigational vaccine. Conclusion Our results support simultaneous seasonal vaccination with RSVPreF3 OA and FLU-QIV in adults ≥ 60 years, as co-administration elicits a statistically non-inferior immune response to the administration of each vaccine alone, with no safety concerns identified. Disclosures Nathali Montenegro, MD, GSK: Support for the present abstract/study Lorena Noriega-Aguirre, MD, ScD, Astra Zeneca: Advisor/Consultant|Astra Zeneca: Honoraria|Astra Zeneca: Support for attending meetings and/or travel|Boehringer Ingelheim: Honoraria|Boehringer Ingelheim: Support for attending meetings and/or travel|GSK: Advisor/Consultant|GSK: Support for the present abstract/study|Novartis: Honoraria Mohammed Bensellam, PhD, GlaxoSmithKline Biologicals SA: Agency worker on assignment at GSK Nathalie De Schrevel, PhD, GlaxoSmithKline Biologicals SA: Employee|GlaxoSmithKline Biologicals SA: Ownership Interest Sherine Kuriyakose, MSc, GSK: GSK Employee Axel Lambert, MSc, GSK: GSK Employee Aurélie Olivier, PhD, GlaxoSmithKline Biologicals SA: I’m an employee of GSK Biologicals|GlaxoSmithKline Biologicals SA: Ownership Interest Veronica Hulstrøm, PhD MD, GlaxoSmithKline Biologicals SA: Employee.

Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons

“…The high efficacy of RSVPreF3 OA observed over 1 year (78.9% against RSV-LRTD) suggests that RSVPreF3 OA may be administered several months before the start of the RSV season without losing substantial clinical benefit throughout the season. This, together with results of studies showing acceptable reactogenicity/safety and no clinically relevant immunological interference of co-administration with influenza vaccines [ 36 , 37 ], supports flexible administration of RSVPreF3 OA, either concomitantly with other vaccines (eg, influenza) at the start of the season or separately ahead of the season.…”