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Microcapsulated Form of the Live Measles Vaccine

#1035


Development of a Microencapsulated Form of the Live Measles Vaccine

Tech Area / Field

  • MED-VAC/Vaccines/Medicine

Status
8 Project completed

Registration date
09.07.1997

Completion date
11.01.2000

Senior Project Manager
Kondratenkov Yu B

Leading Institute
State Research Center of Virology and Biotechnology VECTOR / Institute of Molecular Biology, Russia, Novosibirsk reg., Koltsovo

Supporting institutes

  • Delivery Systems International, Russia, St Petersburg

Collaborators

  • Massachusetts Institute of Technology (MIT), USA, MA, Cambridge\nDépartement d'immunologie / Laboratoire National de Santé, Luxembourg, Luxembourg\nENSAIA le Gout du Savoir, France, Vandœuvre lés Nancy

Project summary

Measles is a child disease characterized by moderate course in the industrially developed countries; however, it is still a topical problem in the developing countries and constitutes a serious health and life menace. According to the'S estimation, 67 million people annually get measles. Of six infectious diseases struggle with which is considered the high-priority task within the WHO's Expanded Immunization Program, measles most frequently causes the lethal outcome. Thus, the struggle with measles, which is also called "children plague", is one of the burning questions of public health care.

The live measles vaccine for parenteral administration based on the vaccinal measles strain Leningrad-16 (L-16) and cell culture of quail embryo fibroblasts has been developed and used in Russia for measles prophylaxis. However, its administration does not exclude the possibility of infecting with hepatitis and AIDS viruses as well as of stressing the vaccinated child. Parenteral administration of the measles vaccine does not always result in the induction of specific protection factors (5 - 10 % of the immunized people are of the refractor group). In addition, measles vaccine is administered to the children older than 12 months who already do not contain the mother's antibodies in their blood. The parenteral vaccines do not allow to overcome the barrier of mother's antibodies in children 6 - 7 months old, which is also a disadvantage of such vaccines. Production of the vaccine also demands considerable expenses at the money- and labor-consuming stages, such as preparation and sterilization of ampules, pouring, lyophilization, and hermetic sealing of the preparation, production and control of the solvent. The vaccination itself should be performed in the specially equipped premises by the qualified personnel and be provided with the sufficient quantity of syringes, needles, ethanol, etc.

Since measles vaccine are mainly used for immunization of nursling children, improving of the delivery of the vaccine into the child organism is of special importance as well as the increase of its immunogenic and protective characteristics through adding of adjuvants, immunostimulators, stabilizing agents, antioxidants, etc., of new generation to the preparation. Microcapsulated and liposomal forms of the live measles vaccine or their combined administration seem to be most promising.

The goal of the present Project is the development of production technology of the microcapsulated form of the live measles vaccine. It should be noted that the oral forms of the measles vaccine are not produced anywhere in the world, the microcapsulated forms included. Thus, both the technological development and the vaccinal preparation itself are completely new. The developed production technology of the microcapsulated form of the live measles vaccine may further serve as a model for creation of the live vaccines against rubella, mumps, influenza as well as bi- and trivaccines against child droplet infections.

Major objectives of the investigations within the proposed Project are the following:


- selection of the optimal composition of stabilizing agents, immunostimulators, adjuvants, antioxidants, and polymers for the microcapsulated form of the vaccine;
- optimization of the conditions for cultivation, lyophilization, and encapsulation of the measles virus strain L-16;
- development of the technology for production of the microcapsulated form of the live measles vaccine;
- production of three experimental batches of the vaccine;
- performance of the preclinical trials of the vaccine in monkeys, including its immunogenic and protective characteristics;
- development of required scientific and engineering specifications for the vaccine production.

Topicality and scientific novelty of the present Project consists in the development of production technology of the microcapsulated form of the live measles vaccine for oral administration. The proposed technology will provide more cheap, standard, and easily administered vaccine.

Production technology of the microcapsulated form of the live measles vaccine will be of commercial value; organization of the large-scale production of the vaccine can be performed in the SRC VB "Vector" with participation of AOZT "Delcy".

Potential role of the foreign collaborators:

Exchange of scientific data within the Project, estimation and discussion of the results obtained.


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