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The Incidence of Tuberculosis in Infants, Siaya District, Western Kenya

Videlis Nduba^1,2, Grace Kaguthi^1,2, Anna H Van't Hoog

¹From the Department of Clinical Epidemiology, Biostatistics and Bioinformatics, University of Amsterdam, Amsterdam, The Netherlands.

The Pediatric Infectious Disease Journal

|February 25, 2020

Insights

Tuberculosis incidence in infants is high, with 2 cases per 100 person-years. Designing new tuberculosis (TB) vaccine trials requires large sample sizes, especially for bacteriologic TB cases.

Area of Science:

Pediatrics
Infectious Diseases
Vaccinology

Background:

Infants are a key population for novel tuberculosis (TB) vaccines.
Accurate TB incidence estimates are crucial for designing clinical trials.
This study aimed to determine TB incidence and cohort retention in young children in a high-burden setting.

Purpose of the Study:

To ascertain the incidence of tuberculosis (TB) in infants up to two years of age.
To evaluate factors influencing TB incidence and study retention in a pediatric cohort.
To inform the sample size calculations for future TB vaccine trials in infants.

Main Methods:

Infants aged 0-42 days were enrolled and followed for up to two years.
Presumptive TB cases were identified via contact history, symptoms, or hospitalization criteria.
Diagnostic methods included induced sputum, gastric aspirates for culture and GeneXpert, Mantoux, HIV testing, and expert radiological assessment.

Main Results:

A total of 69 tuberculosis (TB) cases were diagnosed among 2900 infants.
The overall TB incidence was 2 per 100 person-years; bacteriologic TB incidence was 0.3 per 100 person-years.
Infant HIV infection and higher Keith Edwards scores were associated with bacteriologic TB; vaccination and HIV status influenced retention.

Conclusions:

Tuberculosis incidence is notably high in the studied infant population.
Designing TB vaccine trials requires substantial sample sizes, particularly for bacteriologic endpoints.
Comprehensive diagnostic approaches are essential for accurate TB case ascertainment in infants.

Read full analysis

Abstract

Background:

Infants are a target population for new tuberculosis (TB) vaccines. TB incidence estimates are needed to guide the design of trials. To determine the TB incidence and cohort retention among young children using comprehensive diagnostic methods in a high burden area.

Methods:

Infants 0-42 days were enrolled. Through 4 monthly follow-up and unscheduled (sick) visits up to the age of 2 years, infants with presumptive TB based on a history of contact, TB symptoms or pre-determined hospitalization criteria were admitted to a case verification ward. Two induced sputa and gastric aspirates were collected for culture and GeneXpert. Mantoux and HIV tests were done. Clinical management was based on the Keith Edwards score. Cases were classified into microbiologically confirmed or radiologic, diagnosed by blinded expert assessment. Cox regression was used to identify risk factors for incident TB and study retention.

Results:

Of 2900 infants enrolled, 927 (32%) developed presumptive TB, 737/927 (80%) were investigated. Sixty-nine TB cases were diagnosed (bacteriologic and radiologic). All TB incidence was 2/100 person-years of observation (pyo) (95% CI: 1.65-2.65). Nine were bacteriologic cases, incidence 0.3/100 pyo. The radiologic TB incidence was 1.82/100 pyo. Bacteriologic TB was associated with infant HIV infection, higher Keith Edwards scores. Completeness of 4-month vaccinations and HIV infection were positively associated with retention.

Conclusions:

TB incidence was high. An all TB endpoint would require a sample size of a few thousand children, but tens of thousands, when limited to bacteriologic TB.

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