Immunogenic RSV polypeptides
Inventors
Khurana, Surender • Golding, Hana
Assignees
US Department of Health and Human Services
Publication Number
US-10744193-B2
Publication Date
2020-08-18
Expiration Date
2036-02-18
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Abstract
This invention provides immunogenic compositions comprising an immune stimulant and an respiratory syncytial virus (RSV) oligopeptide or an unglycosylated RSV polypeptide. The RSV oligopeptides are shown in SEQ ID NO: 3-33. The unglycosylated RSV polypeptide may consist essentially of the ectodomain of an RSV G protein, such as that shown in SEQ ID NO: 2 or the ectodomain of an RSV F protein such as the ectodomain of the F protein shown in SEQ ID NO: 39.
Core Innovation
This invention provides immunogenic compositions comprising an immune stimulant and a respiratory syncytial virus (RSV) oligopeptide or an unglycosylated RSV polypeptide. The RSV oligopeptides are shown in SEQ ID NOs: 3-33. The unglycosylated RSV polypeptide may consist essentially of the ectodomain of an RSV G protein, such as that shown in SEQ ID NO: 2 or the ectodomain of an RSV F protein such as that shown in SEQ ID NO: 39.
The problem being solved is that despite the recognition of RSV as a major respiratory pathogen for over 50 years, a vaccine is not yet available because of several inherent problems. These problems include the very young age of the target population, recurrent infections despite prior exposure, and a history of enhanced disease in young children immunized with a formaldehyde-inactivated RSV vaccine. Existing vaccine efforts using live-attenuated vaccines or recombinant subunit vaccines have shown safety and modest immunogenicity challenges, and subunit vaccines based on glycosylated RSV proteins have demonstrated limited neutralizing antibody responses and occasionally enhanced lung pathology.
The invention addresses the need to produce RSV vaccines that provide protective immunity without the potential for disease enhancement. This is achieved by providing immunogenic compositions containing unglycosylated RSV polypeptides, specifically the ectodomain of RSV G or F proteins expressed in prokaryotic cells, or RSV oligopeptides. The compositions induce a protective immune response in subjects including infants, pregnant mothers, females of childbearing age, and elderly persons. The unglycosylated RSV polypeptides and oligopeptides can also be used to detect immune responses to RSV infection.
Claims Coverage
There is one independent claim focusing on an immunogenic composition comprising an RSV oligopeptide and an immune stimulant, and a method claim directed to inducing an immune response by administering such a composition. The main inventive features relate to the specific RSV oligopeptide used, its length, and the inclusion and effective amount of an immune stimulant.
Immunogenic composition comprising an RSV oligopeptide SEQ ID NO: 29 and immune stimulant
An immunogenic composition comprising an immune stimulant and an RSV oligopeptide having the amino acid sequence set forth as SEQ ID NO: 29, which is less than 50 amino acids in length. The immune stimulant is present in an amount effective to stimulate an immune response to the RSV oligopeptide.
Method of inducing an immune response against RSV infection
A method of inducing an immune response against RSV infection in a subject by administering an immunologically effective amount of the above immunogenic composition.
The claims cover immunogenic compositions with a specific RSV oligopeptide and an immune stimulant to elicit immune responses, and methods of administration to induce protective immunity against RSV infection.
Stated Advantages
Nonglycosylated RSV G protein induces strong protective immunity and diverse antibody responses against RSV.
The unglycosylated RSV G protein-based vaccine provides protection against homologous and heterologous RSV strains.
The vaccine using unglycosylated RSV G protein avoids enhanced lung pathology and Th2-skewed immune responses seen with glycosylated G protein vaccines.
The bacterially produced unglycosylated G protein offers an economical approach for a protective RSV vaccine.
Documented Applications
Preventing and treating RSV infection in subjects including infants, pregnant mothers, females of childbearing age, and the elderly by inducing protective immune responses.
Diagnostic assays for detecting RSV-specific immune responses by contacting biological samples with RSV oligopeptides and detecting antibody or cellular immune activity.
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