Journal
VACCINE
Volume 28, Issue 4, Pages 1084-1093Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2009.10.114
Keywords
HyVac4; IC31 adjuvant; BCG; Prime-boost; Tuberculosis; Vaccination; T cell; Protection
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Funding
- Aeras Global TB Vaccine Foundation
- Melinda Gates Foundation
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Despite the extensive success with the introduction of M bovis Bacille Calmette-Guerin (BCG), tuberculosis (TB) remains a major global epidemic infecting between 8 and 9 million people annually with an estimated 1 7 million deaths each year However, because of its demonstrated effectiveness against some of the most severe forms of childhood TB, it is now realized that BCG vaccination of newborns is unlikely to be replaced Therefore, BCG or an improved BCG will continue to be used as a prime TB vaccine and there is a need to develop effective boost vaccines that would enhance and prolong the protective immunity induced by BCG prime immunization We report on a heterologous booster approach using two highly Immunogenic TB antigens comprising Ag85B and TB10.4 (HyVac4) delivered as a fusion molecule and formulated in the proprietary adjuvant IC31 This vaccine was found to be immunogenic and demonstrated greater protection in the more stringent guinea pig model of pulmonary tuberculosis than BCG alone when used in a prime/boost regimen Significant difference in lung involvement was observed for all animals in the HyVac4 boosted group compared to BCG alone regardless of time to death or sacrifice A vaccine toxicology study of the HyVac4 IC31 regimen was performed and it was judged safe to advance the vaccine into clinical trials Therefore, all non-clinical data supports the suitability of HyVac4 as a safe, immunogenic, and effective vaccination in a prime-boost regimen with BCG (C) 2009 Elsevier Ltd. All rights reserved
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