Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults ≥ 50 Years of Age

Co-administration of AS01E-adjuvanted respiratory syncytial virus vaccine (adjuvanted RSVPreF3) and AS01B-adjuvanted recombinant herpes zoster subunit vaccine (RZV), although not contraindicated, has not been previously studied in clinical trials.

This phase III, open-label, randomized (1:1) trial evaluated the immunogenicity, safety, and reactogenicity of adjuvanted RSVPreF3 when co-administered with RZV in ≥50-year-olds. The 2 vaccines were either co-administered at visit 1 (day [D] 1; Co-Ad), or were given sequentially, 1 month apart (RZV dose 1 at D1, adjuvanted RSVPreF3 at D31; Control). All participants received RZV dose-2 at D61. Non-inferiority of humoral immune responses was demonstrated if 95% confidence interval (CI) upper limits for geometric mean RSV-A/B neutralizing titers (GMT) and varicella-zoster virus anti-glycoprotein E (anti-gE) antibody concentration (GMC) ratios (Control/Co-Ad) were ≤1.5. Safety and reactogenicity were secondary endpoints.