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INTRODUCTION

The primary way to prevent TB is to diagnose and isolate infectious cases rapidly and to administer appropriate treatment until patients are rendered noninfectious (usually 2–4 weeks after the start of proper treatment) and the disease is cured. Additional strategies include BCG vaccination and treatment of persons with LTBI who are at high risk of developing active disease.

BCG VACCINATION FOR TUBERCULOSIS

BCG was derived from an attenuated strain of M. bovis and was first administered to humans in 1921. Many BCG vaccines are available worldwide; all are derived from the original strain, but the vaccines vary in efficacy, ranging from 80% to nil in randomized, placebo-controlled trials. A similar range of efficacy was found in observational studies (case–control, historic cohort, and cross-sectional) in areas where infants are vaccinated at birth. These studies and a meta-analysis also found higher rates of efficacy in the protection of infants and young children from serious disseminated forms of childhood TB, such as tuberculous meningitis and miliary TB. BCG vaccine is safe and rarely causes serious complications. The local tissue response begins 2–3 weeks after vaccination, with scar formation and healing within 3 months. Side effects—most commonly, ulceration at the vaccination site and regional lymphadenitis—occur in 1–10% of vaccinated persons. Some vaccine strains have caused osteomyelitis in ~1 case per million doses administered. Disseminated BCG infection (“BCGitis”) and death have occurred in 1–10 cases per 10 million doses administered, although this problem is restricted almost exclusively to persons with impaired immunity, such as children with severe combined immunodeficiency syndrome or adults with HIV infection. BCG vaccination induces TST reactivity, which tends to wane with time. The presence or size of TST reactions after vaccination does not predict the degree of protection afforded.

BCG vaccine is recommended for routine use at birth in countries or among populations with high TB prevalence. However, because of the low risk of transmission of TB in the United States and other high-income countries, the variability in protection afforded by BCG, and its impact on the TST, the vaccine is not recommended for general use. HIV-infected adults and children should not receive BCG vaccine. Moreover, infants whose HIV status is unknown but who have signs and symptoms consistent with HIV infection or who are born to HIV-infected mothers should not receive BCG.

Over the past decade, renewed research and development efforts have been made toward a new TB vaccine, and several candidates have been developed and tested. The MVA-85A vaccine (a modified poxvirus-vectored vaccine that expresses the immune-dominant M. tuberculosis antigen 85A), developed at the University of Oxford, was the first new TB vaccine to be tested in a phase 2B proof-of-concept trial in infants in South Africa. The aim was to evaluate the efficacy of a new preventive TB vaccine candidate against clinical TB or M. tuberculosis infection. Results were published in early 2013: MVA-85A was ...

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