Immunogenicity and safety of a Recombinant gE-Fc Fusion Protein Subunit Vaccine for Herpes Zoster in Adults ≥50 Years of Age: a randomised, active-controlled, non-inferiority trial

Background The licensed adjuvanted recombinant glycoprotein E (gE) subunit vaccine (HZ/su) is highly efficient against herpes zoster (HZ). We compared the immunogenicity and safety of a novel gE-Fc fusion protein subunit vaccine candidate (LZ901) with HZ/su. Methods This was a randomised, active-controlled, non-inferiority trial conducted in Wuxi, China, involving healthy adults aged 50 years and older who had not previously received a HZ vaccine. Eligible participants were randomly assigned (1:1) to receive two doses of LZ901 (30-day interval) or HZ/su (60-day interval). This study was partially blinded, with all participants and investigators without access to the vaccines were masked till 30 days post-first dose, while the laboratory testing personnel remained blinded for the entire trial. Primary outcomes were the proportions…