• Vaccine Name: Ad26/protein preF RSV Vaccine Coadministered With an Influenza Vaccine
• Target Pathogen: Human Respiratory Syncytial Virus
• Target Disease: Respiratory tract disease
• Tradename: Fluarix
• Manufacturer: Janssen (Leiden, the Netherlands)
• Type: Other
• Status: Licensed
• Host Species for Licensed Use: Human
• Antigen: 4 virus strains (15 μg of hemagglutinin per strain per 0.5-mL dose): A/Singapore/GP1908/2015 (H1N1) IVR-180, A/Hong Kong/4801/2014 (H3N2) NYMC X-263B, B/Phuket/3073/2013, and B/Brisbane/60/2008. The placebo was sterile 0.9% saline.
• Preparation: (Sadoff et al., 2021) Each 0.5-mL dose contained 1 × 1011 viral particles (vp) of Ad26.RSV.preF. Fluarix Quadrivalent (GlaxoSmithKline), formulated for the 2017–2018 Northern Hemisphere season, contained the following 4 virus strains (15 μg of hemagglutinin per strain per 0.5-mL dose): A/Singapore/GP1908/2015 (H1N1) IVR-180, A/Hong Kong/4801/2014 (H3N2) NYMC X-263B, B/Phuket/3073/2013, and B/Brisbane/60/2008. The placebo was sterile 0.9% saline.
• Immunization Route: Intramuscular injection (i.m.)
• Description: (Sadoff et al., 2021) The vaccine Ad26.RSV.preF is the next-generation vaccine expressing the stabilized FA2. The vaccine is a replication-incompetent Ad26 vector containing a DNA transgene, encoding a F protein derived from the RSV A2 strain that is stabilized in its pre-F conformation

Human Response

• Host age: 60 years or older (Sadoff et al., 2021)
• Vaccination Protocol: In this phase 2a, double-blind, placebo-controlled study, 180 adults aged ≥60 years received Ad26.RSV.preF plus Fluarix on day 1 and placebo on day 29, or placebo plus Fluarix on day 1 and Ad26.RSV.preF on day 29 (control).
• Challenge Protocol: (Sadoff et al., 2021) Adenoviral vectors adenovirus serotypes 26 and 35 (Ad26 and Ad35), expressing the nonstabilized form of the F protein of the RSV strain A2 induced strong RSV specific humoral and cellular immune responses in mice and were protective in the cotton rat challenge model. Ad26 vectors encoding the RSV F glycoprotein, the most immunogenic antigen in a RSV vaccine [24, 26, 28], have demonstrated high and durable RSV neutralizing antibody titers, a T-helper 1–type cellular immune response and protective immunity in an animal challenge model
• Efficacy: Reported systemic reactogenicity and those graded 3 were generally more frequent after dosing with Ad26.RSV.preF than with Fluarix alone. Systemic reactogenicity was also higher after vaccination with Ad26.RSV.preF alone and in combination with Fluarix in this study than after vaccination with Ad26.RSV.preF alone, as previously reported in study VAC18193RSV1003 for a similar age group. Ad26.RSVpreF was generally well tolerated and had an acceptable safety profile(Sadoff et al., 2021)