A Large, Simple Trial of a Tuberculosis Vaccine

Open Access
Publisher Website
Google Scholar
Abstract
Although there are no new tuberculosis vaccines currently available, it is possible to estimate the infrastructure needed for efficacy trials of such a vaccine. A randomized, placebo-controlled vaccine strategy for community-wide vaccination of adults is proposed: a large, simple trial with recipients stratified at enrollment by human immunodeficiency virus serologic status and purified protein derivative-skin test status. The outcome, tuberculous disease, would be assessed by community-wide surveillance. Such a trial could be carried out in populations in developed countries where the annual incidence of tuberculous disease is >100 cases per 100,000 persons and in developing countries where the incidence is >400 per 100,000 persons. In developed countries, enrollment of 14,600–80,000 persons would be needed, depending on the initial assumptions; in developing countries, enrollment would be 4400–27,000 persons. Readiness for tuberculosis vaccine efficacy trials will require epidemiological field studies to identify potential trial sites and investment in local diagnostic, surveillance, and data management capabilities.