Tuberculosis case finding for vaccine trials in young children in high-incidence settings: a randomised trial

S Moyo1, S Verver, A Hawkridge

  • 1South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine & School of Child and Adolescent Health, University of Cape Town, Cape Town, South Africa. sizulu.moyo@uct.ac.za

Insights

Home visits combined with record surveillance significantly increased tuberculosis case detection in BCG-vaccinated children compared to record surveillance alone. The disease profile remained similar between strategies.

Area of Science:

  • Pediatrics
  • Infectious Diseases
  • Public Health

Background:

  • Tuberculosis (TB) remains a significant global health challenge, particularly in high-burden rural settings.
  • Early and effective case-finding strategies are crucial for controlling TB transmission, especially in vulnerable populations like infants.
  • Bacille Calmette-Guérin (BCG) vaccination is a standard preventive measure, but its impact on TB case detection strategies requires evaluation.

Purpose of the Study:

  • To compare the effectiveness of two distinct TB case-finding strategies in BCG-vaccinated children up to two years of age.
  • To evaluate differences in TB case yield and disease characteristics between active home-based screening and passive surveillance methods.
  • To assess the utility of combining home visits with record surveillance for improved TB detection.

Main Methods:

  • A randomized controlled trial was conducted in a high TB burden rural area of South Africa.
  • BCG-vaccinated infants were enrolled shortly after birth and assigned to either: (1) 3-monthly home visits for TB screening plus record surveillance, or (2) record surveillance only.
  • Standardized investigations were used to evaluate suspected TB cases in both groups over a two-year period.

Main Results:

  • A total of 4786 infants were enrolled, with 2392 in Group 1 and 2394 in Group 2.
  • The TB case-finding rate was significantly higher in Group 1 (2.2/100 person-years) compared to Group 2 (0.8/100 person-years), yielding a rate ratio of 2.6 (95% CI 1.8-4.0).
  • No significant differences were observed in the proportion of bacteriological confirmation, TB symptoms, or signs between the two groups.

Conclusions:

  • Combining home visits with record surveillance demonstrates superior effectiveness in detecting more TB cases in young children compared to record surveillance alone.
  • The clinical and microbiological profile of detected TB cases did not significantly differ between the active screening and passive surveillance groups.
  • These findings support the implementation of integrated active and passive case-finding strategies for enhanced TB detection in high-risk pediatric populations.
Abstract

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