In collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), Sanofi is developing a portfolio of three live-attenuated vaccines (LAVs) for the prevention of serious lower respiratory tract infections (LRTIs) caused by RSV. All three vaccines are administered intranasally and are currently being assessed in young children, with the target population likely to be seronegative infants aged 4−24 months.
Sanofi is developing three intranasal live-attenuated vaccine (LAV) candidates for the prevention of serious lower respiratory tract infections (LRTIs) caused by respiratory syncytial virus (RSV) in seronegative infants aged 4−24 months (Sanofi, 2017b). Intranasal LAVs have the potential to provide superior immunogenicity in pediatric patients compared to inactivated or subunit vaccines because of their ability to elicit both mucosal and systemic immunity, as well as improved cluster of differentiation 8+ (CD8+) T-cell responses. However, Sanofi’s developmental LAVs have been plagued by the challenge of being sufficiently attenuated to allow safe administration to infants, while retaining adequate replicative potential to elicit a balanced humoral and cellular immune response. Another shortcoming of Sanofi’s LAVs is that they are poorly immunogenic in infants aged under six months – the age group at the greatest risk of RSV disease and therefore key targets for vaccination. If GlaxoSmithKline’s and/or Johnson & Johnson’s rival viral vector vaccine approaches are able to demonstrate sufficient protection in infants younger than four months of age, this will be a major blow to the commercial potential of LAVs as physicians are likely to immunize infants as early as possible to reduce the risk of hospitalization.
LIST OF FIGURES
15 Figure 1: Live-attenuated RSV vaccines franchise for RSV prophylaxis – SWOT analysis
18 Figure 2: Potential sales for RSV vaccines in infants across the US and five major EU markets, by country, 2016/17–2025/26
LIST OF TABLES
6 Table 1: RSV cps2 drug profile
6 Table 2: RSV delta NS2/delta 1313/I1314L drug profile
7 Table 3: RSV MEDI delta M2-2 backbone drug profile
9 Table 4: Summary of completed Phase I trials of RSV cps2, RSV D46/NS2/N/delta M2-2-HindIII, and RSV MEDI delta M2-2 for RSV infection
13 Table 5: Summary of ongoing Phase I trial of RSV delta NS2/delta 1313/I1314L and RSV MEDI delta M2-2 for RSV infection
19 Table 6: Potential sales for RSV vaccines in infants across the US and five major EU markets, by country ($m), 2016/17–2025/26
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