Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

Typhoid Clinical Trial

Official title:

Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata, West Bengal, India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125008
• Other study ID #: T-17
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2005
• Last updated: August 25, 2008
• Start date: May 2003
• Est. completion date: January 2008

Study information

• Verified date: August 2008
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Kolkata, India. The cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

Description:

Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs since it has been shown to have consistent efficacy results even in areas of high typhoid incidence, is given as a single dose, lacks patent protection and requires less strict cold chain requirements.

This project attempts to evaluate a new vaccination strategy for residents of endemic areas. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (Hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 2 contiguous urban wards in Kolkata. The vaccines used in this study are internationally produced and locally licensed. A 1 year pilot phase will precede the actual Vi-demonstration project. Surveillance for typhoid fever cases will continue after the mass immunization campaign. A passive surveillance system to evaluate adverse events following immunization will be implemented. Socio-economic studies will be conducted in parallel to the effectiveness evaluation. The knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention will be assessed. Logistic, feasibility and vaccine costs will also be determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37673
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Registered in the project census

• Age >=2 years

• Provide informed consent to receive vaccine

Exclusion Criteria:

• Fever (>37.5 degrees Celsius)

• Pregnancy

• Lactating

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fever
• Paratyphoid Fever
• Typhoid
• Typhoid Fever

Intervention

Biological:
• Typhoid Vi vaccine
single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)
• Hepatitis A vaccine
720 EL.U. of inactivated hepatitis A viral antigen for children 1440 EL.U. of inactivated hepatitis A viral antigen for adults

Locations

Country	Name	City	State
India	National Institute of Cholera and Enteric Diseases	Kolkata	West Bengal

Sponsors (5)

Lead Sponsor	Collaborator
International Vaccine Institute	GlaxoSmithKline, National Institute of Cholera and Enteric Diseases, India, University of Western Ontario, Canada, Wellcome Trust

Country where clinical trial is conducted

India, 

References & Publications (2)

Acosta CJ, Galindo CM, Ochiai RL, Danovaro-Holliday MC, Page AL, Thiem VD, Park JK, Park E, Koo H, Wang XY, Abu-Elyazeed R, Ali M, Albert MJ, Ivanoff B, Pang T, Xu ZY, Clemens JD. The role of epidemiology in the introduction of vi polysaccharide typhoid fever vaccines in Asia. J Health Popul Nutr. 2004 Sep;22(3):240-5. — View Citation

Dutta S, Sur D, Manna B, Bhattacharya SK, Deen JL, Clemens JD. Rollback of Salmonella enterica serotype Typhi resistance to chloramphenicol and other antimicrobials in Kolkata, India. Antimicrob Agents Chemother. 2005 Apr;49(4):1662-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total protection against S. typhi		2 years from zero time	No
Secondary	Indirect protection against S. typhi		2 years from zero time	No
Secondary	Overall protection against S. typhi		2 years from zero time	No
Secondary	Total protection against S. paratyphi		2 years from zero time	No
Secondary	Adverse event(s) following immunization		30 days from vaccination	Yes