GSK-3003891A is an alum-adjuvanted RSV vaccine based on the preF protein. It is currently in Phase II development in the US and EU for the prevention of RSV infection in infants via maternal immunization, but will also be developed in future for elderly individuals aged ≥65 years.
GSK-3003891A (GlaxoSmithKline) is an alum-adjuvanted respiratory syncytial virus (RSV) vaccine based on the prefusion form of the RSV fusion (preF) protein. It is currently in Phase II development for the prevention of RSV infection in infants via maternal immunization, and the company has also expressed its intention to develop the vaccine for use in the elderly in future studies, although no studies are yet planned. In preclinical studies, the prefusion F protein has been shown to be substantially more immunogenic than the post-fusion form utilized in Novavax’s vaccine, and also provided improved protection in hamster and cotton rat challenge studies. Additional structural analysis has also suggested that the prefusion form is the target of the majority of
neutralizing antibodies produced after natural RSV infection, providing a rational basis to expect that vaccination with GSK-3003891A will elicit superior neutralizing antibody responses to vaccines based on the post-fusion form. However, given that GSK-3003891A is likely to launch two years behind Novavax’s rival F protein nanoparticle vaccine in the maternal sector, it must display superior protection rather than just immunogenicity, or else be priced at a discount if it is to capture significant market share.
LIST OF FIGURES
9 Figure 1: GSK-3003891A for RSV prophylaxis – SWOT analysis
12 Figure 2: Potential sales for RSV vaccines for pregnant women across the US and five major EU markets, by country, 2016/17–2025/26
LIST OF TABLES
6 Table 1: GSK-3003891A drug profile
7 Table 2: GSK-3003891A completed Phase II clinical trials in RSV vaccination
9 Table 3: GSK-3003891A completed Phase II clinical trial in RSV vaccination
13 Table 4: Potential sales for RSV vaccines for pregnant women across the US and five major EU markets, by country ($m), 2016/17–2025/26
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