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Pertussoid Aerosol Vaccine

#1439


Pertussoid Acellular Vaccine for Aerosol Application

Tech Area / Field

  • MED-VAC/Vaccines/Medicine

Status
8 Project completed

Registration date
19.01.1999

Completion date
24.05.2005

Senior Project Manager
Gremyakova T A

Leading Institute
Research Center of Toxicology and Hygienic Regulation of Biopreparations, Russia, Moscow reg., Serpukhov

Project summary

The objective of the project is development of technology to obtain acellular pertussoid vaccine for aerosol application.

Cellular ADPT-vaccine (associated diphtheria, pertussis, and tetanus-vaccine) used in Russia up to now, is capable to cause critical vaccinal complications and is rather reactogenic. In many countries of the world cell-free – acellular pertussoid vaccines have been developed and entered in the vaccinal schedule in association with diphtherial and tetanic anatoxins (ADPT-vaccine). The common disadvantage of all pertussoid vaccines is injection way of vaccination which is open to infection by some dangerous viral infections (viral hepatitis, AIDS).

A search of ways for drugs and vaccines introduction, which are alternative to traditional injection method, is conducted all over the world. The prospects for aerosol application of biopreparations have been established, its aerogenic introduction ensures high bioavailability (S. Gizuarson et. al., 1997; J.S. Paton, 1998; L. Brewer-Condon et H. Abrams, 1998). In 1998 the special-purpose laboratory for aerosol vaccination and application of drugs was organised in “Batelle” (USA).

Problem of improvement of pertussis prophylaxis with use of the ADPT-vaccine on the basis of new pertussoid component was accepted so actual, that it was included into Russian Federal purposeful program “Vaccinoprophylaxis in 1999-2000 and for the term up to 2005” adopted by the Government of Russian Federation under the direction of E.Primakov in the Resolution #1260 of October 30, 1998.

The basis for the project is previously developed at the Moscow Research Institute of Vaccines and Serums named after I.I.Mechnikov (MRIVS) the acellular pertussoid vaccine for intramuscular application. Researchers of the MRIVS have patented the method to obtain the anatoxin of B.pertussis, and the instruction for preparing and control of the pertussoid cell-freer adsorbed dry vaccine for intramuscular application has been adopted.

It is believed that the pertussoid acellular vaccine under the aerosol application will allow to prevent undesirable consequences accompanied application of traditional vaccinal preparations. Besides, aerogenic immunisation - to prevent pertussis as droplet infection - should considerably increase prophylactic effectiveness of the vaccine.

To attain this purpose, it is planned to resolve the following tasks:

1. To chose the most antigen – full strain of pertussoid microbe and to prepare on this basis acellular pertussoid preparation (liquid and lyophilised) in amounts necessary for aerosol investigations.


2. To give full biochemical and immunological characteristics of obtained preparations.
3. To justify a choice of an adjuvant for amplification of resorption of pertussoid antigens on mucous membrane of a respiratory tract.
4. To develop technology for obtaining aerosol pertussoid vaccine.
5. To elaborate the method for obtaining and estimation of fixed concentration of vaccinal preparation and antigenic components in aerosol.
6. To elaborate the method for estimation of dissemination of aerosol vaccinal preparation within respiratory tract and internal organs of immunised animals.
7. To select optimum immune dose for aerosol vaccination of experimental animals.
8. To carry out refining study of immunomorphogesesis, effectiveness, and harmfulness of aerosol immunisation by the pertussoid vaccine in experimental animals.
9. To carry out comparative study of immunomorphogenesis, effectiveness, and harmfulness of the pertussoid vaccine under different ways of introduction – aerogenic (aerosol) and parenteral.

EXPECTED RESULTS

As the result of conducted investigations the follows will be developed:


– technology for obtaining the acellular pertussoid vaccine for aerosol immunisation;
– technology for obtaining aerosol of vaccinal preparation with part of particles of size up to 10 мm no less than 90%, including particles of size up to 5 мm no less than 50%;
– experimental substantiation of the method of aerosol immunisation to prevent pertussis, which will provide reliable immune response;
– methodical recommendations on aerosol application of the acellular pertussoid vaccine for immunisation to prevent pertussis.

FOREIGN COLLABORATORS would take part in the project under the following directions:

1) patent–information support of the project;


2) publication of papers in periodic press abroad and in Russia.
3) scientific seminars on discussion the key points of the project implementation.


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