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
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Typhoid Fever
Phase: N/A
Status: Completed
Sponsored by: National Institute of Child Health and Human Development (NICHD)
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.
Clinical Details
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
Study design: Other
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.
Eligibility
Minimum age: 10 Years.
Maximum age: 13 Years.
Gender(s): Both.
Criteria:
- INCLUSION CRITERIA:
Subjects who were involved in the Phase III trial, OH98-CH-N002.
EXCLUSION CRITERIA:
Not specified.
Locations and Contacts
Dong Thap Provincial Hospital, Dong Thap, Vietnam
Pasteur Institute, Ho Chi Minh City, Vietnam
National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
National Institute of Child Health and Human Development (NICHD), 9000 Rockville, Bethesda, Maryland 20892, United States
Additional Information
Related publications: Smith MD, Duong NM, Hoa NT, Wain J, Ha HD, Diep TS, Day NP, Hien TT, White NJ. Comparison of ofloxacin and ceftriaxone for short-course treatment of enteric fever. Antimicrob Agents Chemother. 1994 Aug;38(8):1716-20.
Starting date: October 2006
Ending date: June 2008
Last updated: June 18, 2008
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