A systematic approach to simultaneously evaluate safety, immunogenicity, and efficacy of novel tuberculosis vaccination strategies
Journal Publication ResearchOnline@JCUAbstract
Tuberculosis (TB) is the deadliest infectious disease worldwide. Bacille-Calmette-Guerin (BCG), the only licensed TB vaccine, affords variable protection against TB but remains the gold standard. BCG improvement is focused around three strategies: recombinant BCG strains, heterologous routes of administration, and booster vaccination. It is currently unknown whether combining these strategies is beneficial. The preclinical evaluation for new TB vaccines is heavily skewed toward immunogenicity and efficacy; however, safety and efficacy are the dominant considerations in human use. To facilitate stage gating of TB vaccines, we developed a simple empirical model to systematically rank vaccination strategies by integrating multiple measurements of safety, immunogenicity, and efficacy. We assessed 24 vaccination regimens, composed of three BCG strains and eight combinations of delivery. The model presented here highlights that mucosal booster vaccination may cause adverse outcomes and provides a much needed strategy to evaluate and rank data obtained from TB vaccine studies using different routes, strains, or animal models.
Journal
Science Advances
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Volume
6
ISBN/ISSN
2375-2548
Edition
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Issue
10
Pages Count
14
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Publisher
American Association for the Advancement of Science
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EISSN
N/A
DOI
10.1126/sciadv.aaz1767