Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age

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Typhoid fever
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Brief Title

Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age

Official Title

Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age

Brief Summary

      Typhoid fever remains an important cause of morbidity and mortality in the developing world.
      It is estimated that more than 16 million cases and about 600,000 deaths occur annually, most
      of which occur in Southeast Asia and Africa. Ingestion of food or water contaminated by
      acutely infected persons or chronic carriers is the most common form of transmission. As a
      result, typhoid fever is prevalent where unsafe drinking water or contaminated food is
      common.

      Typhoid fever is highly endemic in Vietnam, especially in the southern provinces and is a
      significant disease in both preschool and school-aged children. Data from Dong Thap
      Provincial Hospital, Mekong delta region showed that among 3,934 hospitalized typhoid fever
      cases from 1990 to 1995, 4.2% had complications and 0.8% died.

      Typhoid fever has become difficult and expensive to treat. About 90% of Salmonella typhi
      isolates are of multidrug-resistant (resistant to chloramphenicol, ampicillin, and
      trimethoprim-sulfamethoxazole) and 76% of isolates showed reduced susceptibility to
      fluoroquinolones. Isolates with full fluoroquinolone or extended spectrum cephalosporin
      resistance have not yet reported in Vietnam but occur sporadically in the Indian
      subcontinent. If they become widespread, alternative treatment options will be limited. The
      improvement of sanitation, provision of safe water and elimination of chronic carriage is not
      expected to be achieved quickly. Accordingly, vaccination against typhoid fever is
      increasingly important national public health priority.

Detailed Description

      Typhoid fever remains an important cause of morbidity and mortality in the developing world.
      It is estimated that more than 16 million cases and about 600,000 deaths occur annually, most
      of which occur in Southeast Asia and Africa. Ingestion of food or water contaminated by
      acutely infected persons or chronic carriers is the most common form of transmission. As a
      result, typhoid fever is prevalent where unsafe drinking water or contaminated food is
      common.

      Typhoid fever is highly endemic in Vietnam, especially in the southern provinces, and is a
      significant disease in both preschool and school-aged children. Data from Dong Thap
      Provincial Hospital, Mekong delta region showed that among 3,934 hospitalized typhoid fever
      cases from 1990 to 1995, 4.2% had complications and 0.8% died.

      Typhoid fever has become difficult and expensive to treat. About 90% of Salmonella typhi
      isolates are of multidrug-resistance (resistant to chloramphenicol, ampicillin, and
      trimethoprim-sulfamethoxazole) and 76% of isolates showed reduced susceptibility to
      fluoroquinolones. Isolates with full fluoroquinolone or extended spectrum cephalosporin
      resistance have not been reported yet in Vietnam but occur sporadically in the Indian
      subcontinent. If they become widespread, alternative treatment options will be limited. The
      improvement of sanitation, provision of safe water and elimination of chronic carriage are
      not expected to be achieved quickly. Accordingly, vaccination against typhoid fever is an
      increasingly important national public health priority.

Study Type

Observational

Condition

Typhoid Fever

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

0

Start Date

October 5, 2006

Completion Date

June 17, 2008

Eligibility Criteria

        -  INCLUSION CRITERIA:

        Subjects who were involved in the Phase III trial, OH98-CH-N002.

        EXCLUSION CRITERIA:

        Not specified.

Gender

All

Ages

10 Years - 13 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00386789

Organization ID

999907004

Secondary IDs

07-CH-N004

Study Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Sponsor

, ,

Verification Date

June 17, 2008