Vaccine development in Russia: current situation and prospects Prof' I'V' Krasilnikov - PowerPoint PPT Presentation

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Vaccine development in Russia: current situation and prospects Prof' I'V' Krasilnikov

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Title: Vaccine development in Russia: current situation and prospects Prof' I'V' Krasilnikov


1
Vaccine development in Russia current situation
and prospects Prof. I.V. Krasilnikov
2
  • Mass immunization allows to
  • decrease the child death rate
  • lengthen live expectancy
  • raise quality of life
  • decrease the risk of invalidization and loss of
    work capacity.

3
  • Vision a world in 2015 in which
  • immunization is highly valued
  • every child, adolescent and adult has equal
    access to immunization as provided for in their
    national schedule
  • more people are protected against more diseases
  • immunization and related interventions are
    sustained in conditions of diverse social values,
    changing demographics and economies, and evolving
    diseases
  • immunization is seen as crucial for the wider
    strengthening of health systems and a major
    element of efforts to attain the Millennium
    Development Goals
  • vaccines are put to best use in improving health
    and security globally and
  • solidarity among the global community guarantees
    equitable access for all people to the vaccines
    they need.

Global Immunization Vision and Strategy (GIVS)
for 2006-2015 (Adopted at the fifty-eighth World
Health Assembly, 28.04.2005)
4
National immunization programmes
5
Vaccine production and RD priorities for
Russian biopharmaceutical industry
  • To develop and launch for public use
  • a Hib Vaccine
  • a Hepatitis C Vaccine
  • an AIDS Vaccine
  • a Human Papilloma Vaccine.
  • To create new antigen delivery systems and
    vaccines in different forms (nasal spray,
    emulsions and etc.).
  • To develop new combined vaccines, gene
    engineering vaccines and therapeutic vaccines.

6
WHO Global Pandemic Influenza Action Plan to
Increase Vaccine Supply (GAP)
  • Objective To increase the supply of a pandemic
    vaccine and thereby reduce the gap between the
    potential vaccine demand and supply anticipated
    during an influenza pandemic (November 2006)
  • Increase in seasonal vaccine use
  • Increased use of seasonal influenza vaccine
    will reduce disease burden of seasonal influenza
    infections, contribute towards the preparedness
    of countries to respond to an eventual pandemic
    and motivate industry to develop greater capacity
    for manufacturing vaccines.
  • Increase in vaccine production capacity
  • Short term Produce enough vaccine to
    immunize two billion people this vaccine should
    be available on the market six months after
    transfer of the vaccine prototype strain to
    industry.
  • Medium and long term Produce enough
    vaccine to immunize the world's population (6.7
    billion)
  • Further research and development
  • The development of more effective influenza
    vaccines using new technologies.

7
WHO Global Pandemic Influenza Action Plan to
Increase Vaccine Supply (GAP)

The ideal product profile is a vaccine which is
safe and highly protective, preferably in all
target groups, including infants, the elderly,
pregnant women and immunosuppressed
individuals is easily and inexpensively
produced on a large scale is effective
preferably with a low dose of antigen is
delivered, ideally, as a single dose, is
thermostable and offers protection for a
minimum duration of one year, including
protection against antigenically drifted viruses.
8
Vaccine for Humans against the Avian Influenza
Virus H5N1 has been successfully developed in RF
  • Three pre-pandemic vaccine candidates based
    on the H5N1 avian influenza virus strain NIBRG-14
    (A/VietNam/1194/ 2004/A/PR8) received from NIBSC
    and the H5N2 avian influenza virus strain
    A/17/Duck/Potsdam/86/92 Len17/H5 developed by
    the Russian scientists were designed in the
    company production sites in Ufa and Irkutsk. They
    are
  • Inactivated subunit adjuvanted with aluminum
    hydroxide
  • Inactivated split adjuvanted with aluminum
    hydroxide
  • Live attenuated influenza vaccine (LAIV)
    stabilized with M-2

9
Clinical studies of prepandemic vaccines
  • H5N1 inactivated prepandemic vaccines
  • Clinical base Research Institute of
    Influenza RAMS in St. Petersburg and Mechnikov
    Research Institute of Vaccines and Sera in
    Moscow.
  • Dose, Volume, Route 2 intramuscular doses
    of the vaccine with 15, 30 and 45 µg of HA in 0.5
    ml, administrated 28 days apart.
  • The number of participants about 600
    healthy adults.
  • H5N2 LAIV candidate (6,9 and 7,5 lg EID50/0,5
    ml)
  • Clinical base Clinic 163 of the Federal
    Medicobiological Agency of Russia (Novosibirsk
    region) and Military Hospital 1137 (Moscow
    region)
  • Dose, Volume Route 2 intranasal doses
    sprayed 0,25 ml into each nasal track (0,5 ml
    dose)
  • with a 10 and 21 days intervals.
  • The number of participants 220 healthy
    adults.
  • Pre-clinical and clinical trials
    demonstrated safety, areactogenicity and high
    immunogenicity of all pre-pandemic vaccine
    candidates. They have induced a strong protection
    against the homologous vaccine strains and the
    other heterologous H5N1 HPAIV strains including
    the Russian epidemic isolate A/Chicken/Kurgan/Russ
    ia/2/2005 (H5N1).

10
  • OrniFlu, an inactivated subunit influenza
    vaccine, and Ultragrivak, a live influenza
    vaccine, are licensed in the Russian Federation.
  • Microgen State Scientific Industrial Company is
    ready to start a large-scale production of avian
    influenza vaccines for humans in the amount that
    will allow to provide the Russian population with
    the vaccine in full.

11
Did I tell you - there will be no avian influenza
!
12
H1N1v influenza vaccines
  • Microgen has designed two pandemic vaccines,
  • an inactivated subunit and LAIV, against new
    H1N1v influenza strain on the base of our
    previously developed pre-pandemic avian flue
    vaccines.
  • The clinical evaluation of these candidate
    vaccines has been started in September and mass
    production is planned to be launched in November
    2009.

13
DEVELOPMENT OF AN ACELLULAR PERTUSSIS VACCINE
  • An acellular pertussis vaccine developed in
    Microgen Scientific Industrual Company is less
    likely to provoke adverse events compared to a
    whole-cell pertussis vaccine because it contains
    purified antigenic components of Bordetella
    pertussis. In terms of immunogenicity it
    possesses the same capacity to confer protection
    upon humans. The acellular vaccine demonstrated
  • a 3-fold decrease in acute toxicity LD50,
  • a 100-fold decrease in anaphylactogenicity,
  • a 120-fold decrease in pyrogenicity,
  • a 9-fold decrease in HSD50,
  • a 19-fold decrease in leucocytosis.
  • Pre-clinical evaluation of the vaccine candidate
    has proved its safety, high histamine-sensitizing
    activity and protective potency.

14
DEVELOPMENT OF A NEW CLASS OF VACCINES THAT
ACTIVATE INNATE IMMUNITY
  • A polybacterial vaccine Immunovac VP-4 composed
    of S.Aureus, E.Coli, K.Pneumonia, P.Vulgaris
    antigen complexes has been created in close
    collaboration with I. Mechnikov Research
    Institute for Vaccines and Sera, RAMS.
  • The clinical studies of the vaccine have shown
    its high efficacy, safety, good tolerability and
    prolonged and potent therapeutic and prophylactic
    effect. High immunogenicity of the vaccine
    preparation can be explained by the phenomenon of
    cross-immunity while safety is obtained by the
    decrease of antigenic load. The polybacterial
    vaccine exerts a positive effect on different
    diseases
  • - bronchial asthma 71
  • - chronic bronchitis 95
  • - lung abscess 75
  • - herpes 90

15
DEVELOPMENT OF A NEW CLASS OF VACCINES THAT
ACTIVATE INNATE IMMUNITY
  • Immunoprophylactics with Immunovac VP-4 allows to
    indicate
  • - 11 time relapse rate reduction in sickly and
    chronic children during 7 months,
  • - 3 time acute respiratory disease rate decrease
    in sickly and chronic children during 12 months,
  • - 6 time allergy disease severity (in scores)
    decrease,
  • - 50 or more tumor size reduction in oncological
    processes.

16
DEVELOPMENT OF A RUBELLA VACCINE
  • In 2007-2008 cell culture-based rubella
    vaccine technology in MRC-5 (Stanley A. Plotkin)
    was developed. The production strains, the seed
    strains and all the intermediate passages of
    rubella virus strains have been obtained. The
    control tests to determine their biological
    sterility, specific activity, physico-chemical
    properties and the absence of mycoplasma have
    been performed. The vaccine candidate has
    entered Phase I clinical trials.
  • The benefits
  • - there is no analogues produced in Russia,
  • - simple and cost-efficient vaccine
    production technology in MRC-5 human diploid-cell
    culture allows rubella virus to be grown at high
    concentrations,
  • - the series of the vaccine candidate for
    children are sorbitol based, there is no nutrient
    medium added, which allows to decrease ballast
    protein concentration.

17
Thank you for attention
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