Clinical trial NCT00125008: Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever
Official title: Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata, West Bengal, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Typhoid
Paratyphoid Fever
Keywords: Salmonella
Typhoid vaccine
enteric fever
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Cholera and Enteric Diseases, India
name: Wellcome Trust
name: University of Western Ontario, Canada
name: GlaxoSmithKline
First posted: 2005-07-29
Enrollment: 37673
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total protection against S. typhi
timeFrame: 2 years from zero time
Secondary outcomes:
measure: Indirect protection against S. typhi
timeFrame: 2 years from zero time
measure: Overall protection against S. typhi
timeFrame: 2 years from zero time
measure: Total protection against S. paratyphi
timeFrame: 2 years from zero time
measure: Adverse event(s) following immunization
timeFrame: 30 days from vaccination
Other outcomes:
Locations:
city: Kolkata
country: India
facility: National Institute of Cholera and Enteric Diseases
state: West Bengal
Study officials:
affiliation: National Institute of Cholera and Enteric Diseases, India
name: Sujit K Bhatttacharya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1128/AAC.49.4.1662-1663.2005. No abstract available.
citation: Sur D, Ochiai RL, Bhattacharya SK, Ganguly NK, Ali M, Manna B, Dutta S, Donner A, Kanungo S, Park JK, Puri MK, Kim DR, Dutta D, Bhaduri B, Acosta CJ, Clemens JD. A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. N Engl J Med. 2009 Jul 23;361(4):335-44. doi: 10.1056/NEJMoa0807521.