Improved Live-Attenuated Vaccine for Respiratory Syncytial Virus (RSV) Bearing Codon-Pair Deoptimized NS1, NS2, N, P, M and SH Genes and Additional Point Mutations in the P Gene


RSV is the most important viral agent of severe respiratory disease in infants and young children worldwide and also causes substantial morbidity and mortality in older adults. RSV is estimated to cause more than 33 million lower respiratory tract illnesses, three million hospitalizations, and nearly 200,000 childhood deaths worldwide annually, with many deaths occurring in developing countries. However, despite the prevalence of RSV and the dangers associated with infection, no RSV vaccine has been successfully developed to date. Accordingly, there is a public health need for RSV vaccines.

This vaccine candidate comprises live RSV that was attenuated by subjecting the protein-coding sequences of the viral NS1, NS2, N, P, M, and SH genes to codon-pair deoptimization, which resulted in many nucleotide substitutions that were silent at the amino acid level but conferred attenuation. In addition, specific amino acid substitutions were identified and introduced into the P protein that improved attenuation and genetic stability. Genetic stability was confirmed in vitro, and attenuation was confirmed in experimental animals.

This live-attenuated RSV vaccine is designed to be administered intranasally by drops or spray to infants and young children. Based on experience with other live-attenuated RSV vaccine candidates, the present candidates are anticipated to be well tolerated in humans and are available for clinical evaluation. The National Institute of Allergy and Infectious Diseases has extensive experience and capability in evaluating live-attenuated RSV vaccine candidates in pediatric clinical studies, and opportunity for collaboration exists.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.



Potential Commercial Applications: Competitive Advantages:
  • Viral diagnostics
  • Vaccine research
 
  • Ease of manufacture
  • B cell and T cell activation
  • Low-cost vaccines
  • Intranasal administration/needle-free delivery


Inventors:

Peter Collins (NIAID)  ➽ more inventions...

Cyril Le Nouen (NIAID)  ➽ more inventions...

Ursula Buchholz (NIAID)  ➽ more inventions...


Intellectual Property:
US Application No. 63/023,949

Collaboration Opportunity:

The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301-594-8730; peter.soukas@nih.gov.


Licensing Contact:
Peter Soukas, J.D.
Email: peter.soukas@nih.gov
Phone: 301-496-2644

OTT Reference No: E-104-2020-0
Updated: Feb 25, 2021