Glaxo RSV vaccines show robust effects with favorable safety profiles

• GlaxoSmithKline (NYSE:GSK) announces positive Phase 1/2 results on two respiratory syncytial virus (RSV) vaccine candidates, GSK3888550A for maternal immunization and GSK3844766A for older adults. The data were presented at the IDWeek conference.
• Both candidates contain a recombinant subunit pre-fusion RSV antigen which is believed to trigger the immune response. The vaccine for older adults also includes the company's proprietary AS01 adjuvant (boosts the immune response).
• In 502 non-pregnant women, '550A showed a 14x increase in RSV-A and RSV-B neutralizing antibody titers at day 8.
• In 1,005 healthy older adults aged 60 - 80 years, '766A showed almost a 10x increase in protective antibodies (RSVPreF3 IgG and RSV-A neutralizing antibodies) a month after immunization. Cellular immunity in older adults was similar to that observed in 48 younger adults (aged 18 - 40 years) who received the non-adjuvanted formulation.
• Both vaccines were well-tolerated. The most common adverse events were injection site pain, fatigue and headache.
• Phase 3 studies in these populations are next up. A Phase 1/2 in RSV-negative infants and a Phase 2 in RSV-positive infants are ongoing.
• Globally, there are ~33M cases of RSV each year in children less than five years old leading to 3M hospitalizations and ~120K deaths. There are no vaccines currently available.
• https://seekingalpha.com/news/3624123-glaxo-rsv-vaccines-show-robust-effects-favorable-safety-profiles