Rotasiil-Liquid Mechanism of Action

Pharmacotherapeutic group: Vaccines, Rota virus, pentavalent, live, reassorted. ATC code: J07BH02.
Pharmacology: Pharmacodynamics: The immune response to natural rotavirus infection is not completely defined. It is known that prior exposure to rotavirus provides incomplete protection from the virus and therefore, infants and children can be reinfected from year to year. Natural infection, however, may provide some protection from severe diarrhea during subsequent infections. This may result from a virus-specific immune response generated at the intestinal mucosal surface. ROTASIIL-Liquid has been developed to mimic the immunologic responses stimulated by natural infection. It is assumed that vaccine virus replicates in the small intestine and induces immunity. The immunologic mechanism by which ROTASIIL-Liquid protects against rotavirus gastroenteritis is not entirely understood. It is thought that IgA antibodies generated against ROTASIIL-Liquid reflect a local immune response. A Phase III study with ROTASIIL assessed the immune response of ROTASIIL-Liquid in 1500 healthy infants. The seropositivity rates post dose 3 were 60.41% and 52.75% for ROTASIIL-Liquid and ROTASIIL respectively. The seropositivity rates indicated that the vaccine is immunogenic in infants. These results are similar to those reported in India for other licensed rotavirus vaccines.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not applicable for vaccines.