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Oral Influenza Vaccine

#3046


Experimental and Clinical Study of a Novel Oral Influenza Vaccine

Tech Area / Field

  • MED-VAC/Vaccines/Medicine
  • MED-OTH/Other/Medicine
  • BIO-CGM/Cytology, Genetics and Molecular Biology/Biotechnology

Status
3 Approved without Funding

Registration date
07.04.2004

Leading Institute
RAMS / Research Institute of Influenza, Russia, St Petersburg

Supporting institutes

  • Institute of Highly Pure Biopreparations, Russia, St Petersburg

Collaborators

  • University of Notre Dame / Freimann Life Science Center, USA, IN, Notre Dame

Project summary

Project Title: Experimental and Clinical Study of a Novel Oral Influenza Vaccine.

Project Aim: Experimental and clinical trials to test a novel oral, inactivated whole virus vaccine which includes a unique adjuvant (a mucoadhesive polysaccharide immunogenesis enhancer, interferon-g (IF-g) inducer).

Great effort has been recently given on development of easily administered, safe, effective influenza vaccines. In particular, interest has focused on vaccines which are administered to mucosal surface such as that which lines the oral cavity and the gastrointestinal tract. Progress in this area has been limited by the availability of safe and effective mucosal adjuvants. Adjuvants are of particular value because they facilitate presentation of viral antigen to local and regional immune cells, and because they can compensate for the immunosuppressive effect of viral hemagglutinin. For example, factors which induce interferon help to stimulate protective immunity to not only influenza but to other respiratory infectious pathogens as well. Further, it is believed that enhancement of immunity by means of IF-g should stimulate not only short-term protection, but also development of long-term immunological memory providing broad spectrum of resistance (type-specific) to influenza virus.

The nasopharynx serves as an entry gate for infection, with many pathogen initially colonizing the mucosal surfaces of the upper respiratory tract. Interestingly, the mucosal immune system is ‘linked’ such that an antigen or vaccine administered at one mucosal surface can stimulate a protective immune response at other, distant mucosal surfaces. In this regard, development an oral vaccine for the respiratory influenza virus is a reasonable and well-grounded approach.

At the State Institution “Research Institute of Influenza” the authors of the suggested Project have developed a drug form of the whole virus influenza inactivated vaccine (IIVT) combined with IF-g inducer for oral application and laboratory technology for preparation of an appropriate vaccine formulation. Further development of the IIVT oral vaccine requires pre-clinical and clinical studies of the vaccine characteristics, including its efficacy, safety and reactogenicity as well as pre-clinical evaluation of the vaccine with a novel adjuvant, corauban.

To accomplish the Project Aim the following issues will be addressed:

1. Preparation of corauban (5 g × 3), determination of its physico-chemical and biological quality characteristics according to the Pharmacopoeia article developed.

2. Investigation in animal trials of specificity of corauban as IF-g inducer by means of various mucosal application methods.

3. Investigation in animal trials of corauban as mucosal immunomodulator by means of oral and intranasal application routes.

4. Investigation in animal trials of specificity of corauban as adjuvant included into composition of a new tablet-form inactivated whole virus influenza vaccine for oral (lingual) application.

5. Assessment in limited volunteer trials of safety, reactogenicity and specificity of oral (lingual) form of inactivated influenza vaccine in tablets (IIVT) with corauban.

Anticipated Results of Proposed Studies:

- Data will be generated to further support and define the immunological and pharmacological properties of corauban adjuvant, a IF-g inducer. Such data will address the general lack of a safe and effective adjuvant for mucosal vaccines.

- Data generated will enlarge potential application fields for corauban; in this regard, successful results will support the use of corauban adjuvant not only in mucosal influenza vaccines but in other mucosal vaccines for humans and animals.

- Data generated will support development and commercialization of a new form of inactivated whole virus influenza vaccine combined with corauban (IIVT) prepared in tablets for oral immunization; this will be accomplished using animal trials.

- Optimal composition (stabilizer + excipient) for a new vaccine drug form will be determined, IIVT quality indices and control measures will be developed, drug expiration date will be determined, and Pharmacopoeia article for the drug will be prepared.

According to the results of limited clinical volunteer trials safety, reactogenicity and specificity for a new oral form of inactivated whole virus influenza vaccine combined with adjuvant (corauban) will be determined, and this data used to support further development and commercialization of the vaccine.


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