Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood

Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi

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 Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

Study Overview

• Status: Completed
• Conditions: Typhoid; Paratyphoid Fever
• Intervention / Treatment: Biological: Typhoid Vi vaccine; Biological: Hepatitis A vaccine

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 due to the following reasons: 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. 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 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.

Secondary objectives of this trial are:

• To monitor the adverse events following a routine Vi mass vaccination campaign;
• To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and
• To study typhoid fever risk factors in the population.

A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi.

• Study Type: Interventional
• Enrollment (Actual): 27231
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Registered in the project census
• Age: 2-16 years

Exclusion Criteria:

• Fever >37.5 degrees Celsius, axillary
• Pregnancy
• Lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Typhoid Vi polysaccharide vaccine	Biological: Typhoid Vi vaccine; Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.; Other Names: Typherix
Active Comparator: 2; Inactivated Hepatitis A vaccine	Biological: Hepatitis A vaccine; single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen; Other Names: Havrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total protection against S. typhi	2 years from zero time

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse event(s) following immunization	30 days from vaccination
Indirect protection against s. typhi	two years from zero time
Overall protection against s. typhi	2 years from zero time

Collaborators and Investigators

• Sponsor: International Vaccine Institute
• Collaborators: GlaxoSmithKline; Wellcome Trust; Aga Khan University; University of Western Ontario, Canada
• Investigators: Principal Investigator: Zulfiqar A Bhutta, MBBS, PhD, Aga Khan University

Publications and helpful links

General Publications

• 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.
• Ali M, Rasool S, Park JK, Saeed S, Ochiai RL, Nizami Q, Acosta CJ, Bhutta Z. Use of satellite imagery in constructing a household GIS database for health studies in Karachi, Pakistan. Int J Health Geogr. 2004 Sep 28;3(1):20. doi: 10.1186/1476-072X-3-20.

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: July 28, 2005
• First Submitted That Met QC Criteria: July 28, 2005
• First Posted (Estimate): July 29, 2005

Study Record Updates

• Last Update Posted (Estimate): August 26, 2008
• Last Update Submitted That Met QC Criteria: August 25, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: enteric fever; Salmonellosis; typhoid vaccine
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Salmonella Infections; Typhoid Fever; Paratyphoid Fever; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: T-7