Multivalent huma-bovine retavirus vaccine

A technology of bovine rotavirus and rotavirus, applied in the field of multivalent human-bovine rotavirus vaccine

Inactive Publication Date: 2008-05-14
GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE DEPT OF HEALTH & HUMAN SERVICES THE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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.

Method used

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  • Multivalent huma-bovine retavirus vaccine
  • Multivalent huma-bovine retavirus vaccine
  • Multivalent huma-bovine retavirus vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment I

[0038] This example describes rotaviruses derived from human rotavirus strains D (VP7:1), DS-1 (VP7:2), P (VP7:3) and ST (VP7:4) and bovine UK Compton (UK) rotaviruses. The rotavirus rearrangements were prepared, and the safety, immunogenicity and reactogenicity of each rearrangement were evaluated for adults, children and infants.

[0039] From bovine UK Compton (UK) strains and from human rotavirus strains D (VP7 serotype 1, ATCC VR-970), DS-1 (VP7 serotype 2; Wyatt et al., Perspect. Virol. 10:121-145 (1978)) and P (VP7 serotype 3, Wyatt et al., Science 207:189-171 (1983)) and ST3 (VP7 serotype 4; Banatvala et al., Journal of the American Veterinary Medical Association (J.Am. Vet. Med. Assoc.) 173:527-530 (1978)) derived human X bovine rearranged rotavirus strains representing VP7 serotypes 1, 2, 3 and 4. Human rotavirus strains D, DS-1 and P were recovered from the stool of children hospitalized with diarrhea; strains D and DS-1 were propagated and passaged in sterile calv...

Embodiment II

[0074] This example describes a tetravalent human x bovine rearranged rotavirus immunogenic composition evaluated for its clinical safety and immunogenicity in adults, children and infants.

[0075] The four human x bovine rearranged rotaviruses described in Example 1 were mixed in equal volumes to form a single tetravalent vaccine composition. All studies were performed in a placebo-controlled fashion to evaluate the safety and immunogenicity of the mixed compositions. All serotyping and microbiological determinations were performed as described in Example 1.

[0076] A single dose of undiluted 10 5.3 -10 5.8PFU per rearranged quadrivalent human (VP7 serotypes 1, 2, 3 and 4)-bovine UK rotavirus vaccine. Study subjects fasted for at least 1 hour before or after administration of the vaccine or placebo. They were given 120 ml of a buffer (sodium bicarbonate) to neutralize stomach acid, followed one minute later by either the tetravalent immunogenic composition mixed with th...

Embodiment III

[0092] This example provides data from an ongoing clinical trial comparing the preferred tetravalent human-bovine rearranged rotavirus composition of the invention with the approved tetravalent macaque-human rotavirus rearranged vaccine ROTASHIELD. Summary of preliminary phase analysis. This assay examined the proportion of low-level febrile responses and protective efficacy against rotavirus diarrhea for both compositions.

[0093] A phased two-year clinical study is currently underway to compare the quadrivalent human-bovine rearranged rotavirus composition of the present invention with the quadrivalent macaque-human rotavirus rearranged vaccine (recently approved in 15 countries in the United States and the European Community) Safety and efficacy of anti-rotavirus diarrhea using ROTASHIELD). The study was conducted in Finland and included 172 quadrivalent human-bovine rotavirus rearrangement subjects, 86 corresponding placebo controls, 161 ROTASHIELD vaccinators and 79 cor...

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/12A61K39/15A61P31/12A61P31/14
CPCA61K39/15A61K2039/545C12N2720/12334A61K2039/70A61K39/12A61P1/12A61P31/12A61P31/14A61P37/00
Inventor A·H·卡比奇安R·M·查诺克星野安孝
Owner GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE DEPT OF HEALTH & HUMAN SERVICES THE
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