Ad26.RSV.preF, in development by Johnson & Johnson, is a replication-deficient vector vaccine that encodes a prefusion form of the RSV F protein. The vaccine is currently in Phase I/II development in the US and EU for the prevention of RSV infection in infants aged <24 months, as well as elderly patients aged ≥60 years, and is being investigated in prime-boost schedules. The vaccine is designed to stimulate both serum neutralizing antibody responses and strong T-cell responses to the F protein.
Johnson & Johnson is developing a replication-deficient adenovirus vector vaccine, Ad26.RSV.preF, which encodes a prefusion form of the respiratory syncytial virus (RSV) fusion (F) protein and is being developed for use in infants aged <24 months, as well as the elderly aged ≥60 years. Viral vector approaches could be preferable to Sanofi’s live-attenuated vaccines (LAVs) because Ad26 is not neutralized by pre-existing maternal antibodies, potentially allowing the vaccine to be administered to infants aged <6 months, which is when the risk of serious RSV infection is highest. In the pediatric sector, Johnson & Johnson will also face competition from GlaxoSmithKline’s viral vector vaccine (ChAd155-RSV), as well as Novavax’s nanoparticle RSV F vaccine. The vaccine will also need to compete for market share within the elderly population, as Bavarian Nordic (MVA-BN RSV) and Novavax (RSV F) are both developing vaccines targeting this lucrative patient population. Johnson & Johnson hopes that the inclusion of a prefusion form of the RSV F protein will result in superior protection to that afforded by rival vaccines encoding less immunogenic post-fusion forms, but a potential weakness of the company’s vaccine is that it does not include the conserved internal matrix (M2) and nucleocapsid (N) viral proteins, which are known targets of cellular immunity. However, the contribution of cellular immunity to protection is still controversial, and so future Phase II proof-of-efficacy data from studies investigating rival vaccines designed to elicit cellular immunity will be pivotal determinants of Johnson & Johnson’s competitiveness in the RSV vaccines field.
LIST OF FIGURES
10 Figure 1: Ad26.RSV.preF RSV for RSV prophylaxis – SWOT analysis
13 Figure 2: Potential sales for RSV vaccines across the US and five major EU markets, by risk group, 2016/17–2025/26
LIST OF TABLES
6 Table 1: Ad26.RSV.preF drug profile
7 Table 2: Ad26.RSV.preF ongoing Phase I/II clinical trials in RSV vaccination
14 Table 3: Potential sales for RSV vaccines across the US and five major EU markets, by risk group ($m), 2016/17–2025/26
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