[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Page 14952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05294]



[[Page 14952]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301-594-8730; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Method of Vaccination With an Attenuated RSV Vaccine Formulation

    Description of Technology: Acute respiratory infections during 
early childhood constitute a major human health burden. Human 
respiratory syncytial virus (RSV) is the most common and important 
viral cause of severe acute pediatric respiratory infections worldwide. 
Mortality due to RSV in the post-neonatal (28 days to 1 year old) 
population is second only to malaria. It is estimated that RSV causes 
34 million lower respiratory tract infections, 4 million 
hospitalizations, and 66,000-199,000 deaths every year in children less 
than 5 years of age. Most mortality occurs in the developing world 
where clinical care is less accessible. Mortality is low in the 
developed countries, but the morbidity is substantial: In the United 
States alone, RSV is associated with an estimated 132,000-172,000 
hospitalizations annually in children less than 5 years old. There is 
not yet available a vaccine or an effective antiviral drug suitable for 
routine use.
    This application claims a method of vaccinating a human subject 
against Respiratory Syncytial Virus (RSV) by administering a 
composition comprising an immunogenic amount of a recombinant RSV 
particle to the subject. An embodiment of the composition comprising 
the recombinant RSV particle was evaluated as a live intranasal vaccine 
in adults, RSV-seropositive children and RSV-seronegative children. 
When results in RSV-seronegative children were compared to those 
achieved with the previous leading live attenuated RSV candidate 
vaccine, vaccine virus shedding was significantly more restricted, yet 
the post-vaccination RSV-neutralizing serum antibody achieved was 
significantly greater. Surveillance during the subsequent RSV season 
showed that several RSV-seronegative recipients had substantial rises 
of RSV-neutralizing serum antibodies indicative of exposure to RSV, and 
yet without reported RSV-associated illness, suggesting that the 
vaccine was protective yet primed for anamnestic responses to RSV. 
Thus, the composition comprising the recombinant RSV particle was 
intrinsically superior at eliciting protective antibody in the 
subjects. Surprisingly, a single dose of the composition was sufficient 
to provide the greater antibody response and protective effect in 
seronegative and/or RSV-naive infants and children of less than about 
24 months of age. This was an unexpected result, as it is currently 
anticipated that vaccination against RSV using a live, attenuated RSV 
vaccine will require administration of multiple doses, at least two or 
three at a minimum, in a single vaccination season to provide 
protective result.
    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:
     Viral therapeutics
     Viral diagnostics
     Vaccine research
    Competitive Advantages:
     Ease of manufacture
     Adjuvant unnecessary
     Favorable safety profile in clinical trials
    Development Stage:
     In vivo data assessment (human)
    Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID).
    Intellectual Property: HHS Reference No. E-067-2016-0 --U.S. 
Provisional Application Nos. 62/251,030, filed November 4, 2015, 62/
259,472, filed November 24, 2015, and 62/263,405, filed December 4, 
2015, PCT Patent Application Number PCT/US2016/060672, filed November 
4, 2016, European Patent Application Number 1694904.9, filed November 
4, 2016 (pending), United States Patent Application Number 15/773,653, 
filed May 4, 2018 (pending).
    Licensing Contact: Peter Soukas, J.D., 301-594-8730; 
[email protected].
    Collaborative Research 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; [email protected].

    Dated: March 10, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-05294 Filed 3-13-20; 8:45 am]
 BILLING CODE 4140-01-P