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