Things are heating up in the race for a respiratory syncytial virus (RSV) vaccine. Novavax reported Phase II results for its investigational vaccine just a week ago, and now, Danish biotech Bavarian Nordic is starting a Phase I trial of its candidate.
The trial will take place in the U.S. and will involve 63 adults aged 18 to 65, the company said in a statement. Study participants will be divided into three groups, each receiving a different dose of the candidate, MVA-BN RSV. One group will comprise adults aged 50 to 65 years to assess the immune responses in older adults, a key target for the vaccine. This group will receive a higher dose. Volunteers will receive two shots of the candidate or placebo.
No vaccine for RSV currently exists, though both Novavax ($NVAX) and AstraZeneca's ($AZN) MedImmune got their candidates fast-tracked by the FDA. RSV is by far the most common cause of lower respiratory tract infection in children worldwide. According to the CDC, in the U.S., RSV leads to more than 57,000 hospitalizations of children younger than 5 years and 177,000 hospitalizations and 14,000 deaths among adults older than 65.
In addition to a Phase II trial in older adults, Novavax's candidate is in a Phase II trial in pregnant women to assess the vaccine in infants via maternal immunization. MedImmune's candidate is in Phase I trials involving healthy adults and a Phase Ib/IIa study in healthy preterm infants.
- here's the release