Respiratory syncytial virus (RSV), a highly contagious viral disease, is a common cause of bronchiolitis and pneumonia – and the number one cause of childhood hospitalization worldwide. BlueWillow’s intranasally delivered nanoemulsion (NE) vaccine adjuvant shows promise in supporting the development of a safe and efficacious RSV vaccine.
Respiratory syncytial virus (RSV) is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. It is the number one cause of childhood hospitalization in the U.S. and around the world. Nearly all children are infected with the virus at least once by the age of 2 to 3 years. The disease is particularly dangerous for premature babies, children with other health conditions, and the elderly. Many children develop pulmonary disease and/or asthma from RSV that persists throughout adult life making them susceptible to re-infection.
Currently there are no approved vaccines for RSV.
In 2010, BlueWillow Biologics received a $6 million grant from the Bill & Melinda Gates Foundation to support the development of a safe and effective nanoemulsion (NE) adjuvanted vaccine for RSV. The grant supported BlueWillow’s initial preclinical development program, including studies in mice, cotton rats, and non-human primates. These studies demonstrated that both intranasal and intramuscular NE-RSV vaccines induce robust protective immunity, without eliciting the enhanced respiratory disease that has caused other RSV vaccine candidates to fail.
The studies in mice conducted under the grant by the University of Michigan and BlueWillow have been published1. These studies demonstrated robust Th1, Th17, and antibody responses from intranasal NE-RSV vaccination, as well as protection following challenge.
Studies in non-human primates demonstrated that intranasal NE-RSV vaccination elicited near complete protection following challenge. The first chart below measured virus following challenge in the lung of the animals, as determined by the bronchoalveolar lavage (BAL):
A second chart measured virus in the nasal wash of the animals following challenge, an indication of the mucosal immune response elicited by the intranasal NE vaccine:
1 Lindell 2011 PLoS ONE 6:e21823; “A Novel Inactivated Intranasal Respiratory Syncytial Virus Vaccine Promotes Viral Clearance without Th2 Associated Vaccine-Enhanced Disease”
In July 2013, BlueWillow entered into an agreement with the Division of Microbiology and Infectious Diseases (DMID), a division of NIAID. Under the agreement, DMID has agreed to fund certain activities and studies in support of developing an intramuscular NE vaccine for RSV. Such activities and studies are currently ongoing.