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Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG

Michele Tameris1, Helen McShane, J Bruce McClain

  • 1South African TB Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine (IIDMM) and School of Child and Adolescent Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester, Western Cape 6850, South Africa. michele.tameris@uct.ac.za

Tuberculosis (Edinburgh, Scotland)
|February 16, 2013
PubMed

Insights

Developing new tuberculosis (TB) vaccines is crucial. This infant TB vaccine trial in South Africa provided valuable lessons for future efficacy studies, highlighting the need for operational efficiency and close monitoring of TB case accrual.

Area of Science:

  • Vaccinology
  • Infectious Disease Epidemiology
  • Clinical Trial Design

Background:

  • Global tuberculosis (TB) epidemic necessitates novel vaccine development.
  • A Phase IIb trial evaluated MVA85A vaccine efficacy in South African infants.
  • The study aimed to assess proof-of-concept for TB prevention in infants.

Purpose of the Study:

  • To detail the design and implementation of an infant TB vaccine efficacy trial.
  • To identify challenges and solutions encountered during the trial.
  • To inform future TB vaccine trial strategies.

Main Methods:

  • Randomized, controlled, double-blind trial of MVA85A versus Candin control.
  • Participants: 4-6-month-old, BCG-vaccinated, HIV-negative infants in rural South Africa.
  • Follow-up: 15-39 months for incident TB disease with pre-specified endpoints.

Main Results:

  • 2797 infants enrolled over 22 months.
  • Recruitment challenges were identified and addressed.
  • Slow TB case accrual necessitated a six-month extension of follow-up.

Conclusions:

  • Modern infant TB vaccine trials face different regulatory and research environments compared to historical BCG trials.
  • Future trials require adequate resources and optimized operations.
  • Stringent TB case definitions and close monitoring of case accrual are essential for trial success.
Abstract

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