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Recombinant Human Parvovirus B19 Virus-Like Particle Vaccine
     


Recombinant Parvovirus B19
virus like particles
manufactured by Meridian

Meridian Life Science, Inc. manufactured, and subsequently licensed, a recombinant Parvovirus B19 (HPVB19) vaccine under a contract from the National Heart, Lung and Blood Institute of the National Institutes of Health.  The vaccine was manufactured according to cGMP and has been used in Phase I/II safety/efficacy trials.  The vaccine consists of two viral proteins (VP1 and VP2) in separate Baculovirus vectors that are co-infected at the correct multiplicity of infections (MOI’s) into Sf9 cells and that, upon expression, self assemble into immunogenic virus-like particles.  Meridian Life Science has a validated cGMP vialing line for this product of up to 2,500 vials.


Paravovirus B19 from
patient sample by TEM

 
Background of Human Parvovirus B19:
  • HPVB19:
    • Parvoviruses are small DNA viruses that infect rapidly dividing cells and cause a diversity of diseases in animal species
    • Parvovirus B19 is the only Parvoviridae species to cause disease in man
    • Global and common infection in humans
  • HPVB19 Infection in the Healthy Host:
    • Fifth Disease: in normal individuals, Parvovirus B19 causes a rash illness in children (Fifth disease) and an arthralgia syndrome in adults
    • Human virulence varies by age, immunologic, and hematologic status
    • Typical prevalence of IgG antibodies against HPVB19:
     
   
  • HPVB19 Infection in Susceptible Populations:
    • Transient Aplastic Crisis: In patients with underlying Hemolysis, HPVB19 causes temporary cessation of red cell production and severe anemia; can be fatal
      • Sickle Cell Anemia
      • Other genetic hemolytic anemias
    • Immunosuppressed individuals, HPVB19 persists and causes severe anemia and pure red cell aplasia
    • HPVB19 infection during pregnancy can result in transmission to the fetus, hydrops fetalis, and fetal loss
 

 

 

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