A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

Summary

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged \>=50 years of age.

Timeline

Start

2023-07-28

Primary completion

2024-02-19

Completion

2024-07-29

Outcome

Met primary endpoint

paper Neutralizing GMT ratios for RSV-A (1.1 [95% CI = 1.0-1.4]) and RSV-B (1.0 [0.8-1.2]), and anti-gE antibody GMC ratio (1.2 [1.1-1.4]) met non-inferiority criteria. PMID 42054374 ↗

registry analysis (non-inferiority test); Co-administration Group vs Control Group; Ratio 1.24 (95% CI 1.08 to 1.42) NCT05966090 ↗

registry analysis (non-inferiority test); Co-administration Group vs Control Group; ratio 1.14 (95% CI 0.97 to 1.35) NCT05966090 ↗

registry analysis (non-inferiority test); Co-administration Group vs Control Group; ratio 0.98 (95% CI 0.84 to 1.15) NCT05966090 ↗

Publications

• Roussy JF, Dennis P, Gupta AK, Wallace G, Abitbol A, Aggarwal N, Surber JG, Lee T, Smith BA, Gerard C, Hailemariam HA, David MP, Jastorff AM, Van der Wielen M. 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. Clin Infect Dis. 2026 Apr 29:ciag208. doi: 10.1093/cid/ciag208. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HZ/su vaccine	Vaccine	—	Intramuscular
Subject	RSVPreF3 OA	Vaccine	—	Intramuscular

Indications