BACKGROUND
Respiratory Syncytial Virus (RSV) is the largest viral cause of pediatric bronchiolitis worldwide, a respiratory disease that results in over 100,000 deaths per year. RSV can also cause adult lung diseases such as pneumonia and poses a serious risk for the elderly and the immunocompromised. Unfortunately, a vaccine for RSV is not currently available. Although, live-attenuated (weakened) RSV virus offers the most promise for a future vaccine, previous and current efforts have failed to produce a vaccine that is both effective and safe to use without the risk of severe side effects.
SUMMARY OF TECHNOLOGY
OSU Researchers have developed a novel live attenuated RSV vaccine in which the M protein has been deleted (Mnull RSV). This vaccine candidate allows to control the rate of cell-to-cell transmission of human RSV, making it possible to tailor vaccines to the strength each person needs for maximum protection without side effects. The Mnull RSV can be developed for use in small children and immunocompromised patients who require more stringent safety conditions. This vaccine candidate has been tested in two in-vivo disease models. The new method has also been developed and optimized enabling to produce titers at levels required for a commercial vaccine.
POTENTIAL AREAS OF APPLICATION
- Prevention of human RSV outbreaks through immunization of infants and young children.
MAIN ADVANTAGES
- Virus cell to cell transmission can be blocked entirely or fine-tuned to different levels;
- Improved vaccine safety;
- Higher antigen production, recognition, and efficacy;
- Easier production than attenuated viruses;
- Controlled spread of virus without negative side effects;
- Optimized cell line method allowing to produce titers of >107 PFU/ml routinely.
STAGE OF DEVELOPMENT
Support from the NIH and the Oklahoma Center for the Advancement of Science & Technology (OCAST) was used to generate proof of concept data including experiments in a mouse model showing (i) reduced weight loss and alleviated airway resistance following administration of our lead RSV vaccine candidate, (ii) induction of immune response, as measured by activation of CD8+ and CD4+ T cells, at a level close to the one observed with a wildtype RSV virus. Data from trials in infant baboons demonstrates that our vaccine candidate (i) protects against tachypnea induced by RSV challenge, (ii) reduces overall illness induced by RSV challenge, (iii) reduces viral replication in BAL fluid, (iv) induces low serum RSV neutralizing antibody responses and (v) primes for accelerated NA responses after infection.
Awarded NIH STTR Phase I grant for preclinical evaluation in a baboon model.
COMMERCIAL OPPORTUNITY
Respiratory syncytial virus infection represents the major cause of hospitalization of infants in the US with up to 120,000 annual RSV admissions. Causing as many as 200,000 annual infant deaths worldwide, RSV has an estimated >$3 billion cost associated with management of RSV infection in infants and children. Palivizumab has been the only RSV-specific treatment on the market with peak sales of >$1.1 billion in 2010.