Multivalent huma-bovine retavirus vaccine

Abstract

The present invention provides vaccine compositions for protection against human rotaviral disease without significant reactogenicity. Human×bovine reassortant rotavirus comprising each of the four clinically most important VP7 serotypes of human rotavirus are combined in a multivalent formulation which provides a high degree of infectivity and immunogenicity without producing a transient febrile condition. Methods for producing an immunogenic response without producing a transient febrile condition are also provided.

Description

Background of the invention [0001] Rotavirus is a major cause of acute dehydrating diarrhea in infants and young children. Rotavirus disease is responsible for 25% to 30% of infant gastroenteritis deaths in developing countries and approximately 50,000 to 100,000 hospitalized children under 5 years of age in the United States. For this reason, safe and effective vaccines are needed to prevent severe rotavirus disease in infants and young children. [0002] The main strategy for developing rotavirus vaccines is based on the "Jennerian" approach, which exploits the antigenic relatedness of human and animal rotaviruses and the reduced virulence of animal rotavirus strains in humans. Kapikian et al., Vaccines, in Chanock et al., eds. Cold Spring Harbor Experimental Press, Cold Spring Harbor, New York, pp. 151-159 (1987). Several candidate live oral rotavirus vaccines have been developed using this approach, in which antigenically related live viruses obtained from non-human host...

AI Technical Summary

Problems solved by technology

Such transient febrile episodes or symptoms, while generally considered acceptable by parents and clinical trial health care providers, may not be tolerated in certain circumstances, such as those that may have low levels of passively acquired resistance to rotavirus. Premature infants with maternal antibodies, etc.