Recombinant Stabilized Prefusion Protein of Respiratory Syncytial Virus for Use as a Subunit Vaccine

The invention, a stabilized recombinant prefusion F protein (pre F), is a candidate subunit vaccine for Respiratory Syncytial Virus (RSV). Pre-F is stabilized in the prefusion conformation and displays epitopes not present in postfusion F protein. Several potent RSV neutralizing antibodies bind pre F, but not postfusion F. Therefore, immunization with pre F may elicit an immune response superior to the response generated by postfusion F.

NIH researchers have engineered pre F to expose an antigenic site 0, which is targeted by extremely potent RSV neutralizing antibodies. Structure-based design yielded several stabilized variants of pre F that maintained exposure of antigenic site 0 when subjected to extremes of pH, osmolality and temperature.

Preclinical in vivo data on stabilized pre F is available. Immunization of mice and macaques with antigenic site 0 stabilized pre F variants elicited high levels of RSV specific neutralizing activity.

Potential Commercial Applications: Competitive Advantages:
  • Vaccine for Respiratory Syncytial Virus
  • Vaccine stably exposes antigenic site in RSV F that permits generation of potent RSV neutralizing antibodies.
  • There is currently no RSV vaccine on the market.

Michael Joyce (NIAID)
Jason McLellan (NIAID)
Barney Graham (NIAID)
Peter Kwong (NIAID)
Baoshan Zhang (NIAID)
Masaru Kanekiyo (NIAID)

Intellectual Property:
US Application No. 61/780,910
US Application No. 61/798,389
US Application No. 61/857,613
US Application No. 61/863,909

McLellan JS, et al. PMID 23618766
McLellan JS, et al. PMID 24179220

Collaboration Opportunity:

The National Institute of Allergy and Infectious Diseases, Vaccine Research Center, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize an RSV vaccine based on pre F, a stabilized recombinant RSV F protein. For collaboration opportunities, please contact Rosemary C. Walsh, Ph.D. at 301-541-3528 or

Licensing Contact:
Cristina Thalhammer-Reyero , Ph.D., M.B.A.
NIH Office of Technology Transfer
Phone: 301-435-4507

OTT Reference No: E-081-2013/0

Updated: Jan-27-2014