ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00386789
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

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.


Condition or disease
Typhoid Fever

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
Enrollment : 0 participants
Time Perspective: Other
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 Start Date : October 5, 2006
Study Completion Date : June 17, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

Not specified.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386789


Locations
United States, Maryland
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, United States, 20892
Vietnam
Dong Thap Provincial Hospital
Dong Thap, Vietnam
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam
Pasteur Institute
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications:
ClinicalTrials.gov Identifier: NCT00386789     History of Changes
Other Study ID Numbers: 999907004
07-CH-N004
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 17, 2008

Keywords provided by National Institutes of Health Clinical Center (CC):
Typhoid Fever
Serological Survey
Follow-Up
Protection

Additional relevant MeSH terms:
Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs