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OCTOBER 2018    A Monthly Review of Articles of Interest for the Clinical Community

..This Month's Clinical Focus:  INFECTIOUS DISEASE..

 

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Promise for Future of TB Vaccine Development


TB Vaccine Clinical Programs and Data from Two Phase II Clinical Trials for M72/AS01E

 

The New England Journal of Medicine (NEJM) published the results of a clinical study conducted by Aeras in collaboration with GSK, evaluating GSK's investigational TB vaccine candidate, M72/AS01E.


TB Test-2 vaccination-67477_1920 by WikiImages PIXABAY Free Lic CC0The Phase IIb efficacy study showed that the vaccine protected against active pulmonary TB disease, with an overall vaccine efficacy of 54 percent. This finding, if confirmed in follow-up studies, would represent a breakthrough in the decades-long quest to develop an effective TB vaccine. The study involved 3,573 HIV-negative adults in three countries in Africa (Kenya, South Africa, and Zambia).
 

These results follow another Aeras Phase II study recently published in the NEJM showing the potential to prevent sustained TB infection among high-risk adolescents. The study involved the currently available bacille Calmette-Guerin (BCG) vaccine and an experimental subunit vaccine candidate, H4:IC31®, which uses the IC31® adjuvant available under license from Valneva. The study was conducted through a partnership between Aeras and Sanofi.
 

Mark Feinberg, M.D., Ph.D., president and CEO, IAVI, said, "Aeras' contributions to these two important studies have built excitement in the field, demonstrating that an effective TB vaccine may be achievable. The transfer of Aeras research capabilities to IAVI will enable this important work to continue." Dr. Feinberg continued, "There is extensive overlap among individuals and communities hit hardest by TB and HIV/AIDS; TB is the single biggest killer of people living with HIV, and, in some parts of the world, the HIV pandemic has fueled the spread of TB." Further information about the M72/AS01E study is available at the link.

About TB:  Tuberculosis (TB) is the world's deadliest infectious disease and is increasingly characterized by antimicrobial resistance. In 2017, there were 1.6 million deaths and 10 million new cases of TB disease. The World Health Organization (WHO) estimates that nearly one-quarter of the world's population has latent TB infection, meaning that they are infected with TB bacteria that could develop into active TB disease. Teens and adults are most at risk for developing and spreading TB. An estimated 19 percent of TB-related deaths, and 9 percent of new TB cases, were among people living with HIV. The risk of developing TB disease is estimated to be 20 times higher among the 37 million people living with HIV than it is for those without, and TB accounts for about one in three AIDS-related deaths.


SOURCE: Used by Permission of PRNewswire


Favorable Outcomes Data for Adjuvanted Trivalent Influenza Vaccine (FLUAD®)

 

New studies highlight health and economic benefits of adjuvanted trivalent influenza vaccine amongst two at-risk populations

 

Seqirus presented new healthcare and cost outcomes data for its MF59®-adjuvanted trivalent influenza vaccine (FLUAD) at IDWeek in San Francisco (October 5-6). Results are from studies conducted in two vulnerable populations – 3 studies in individuals 65 years+ and two studies in young children – show:
    
• Improved immune response in those 65 years and older associated with an increase in the dose of adjuvant MF59
    
• A significant reduction of 6% in all-cause hospitalization among elderly persons aged 65 years and above who live in U.S. nursing homes and received MF59-adjuvanted trivalent influenza vaccine compared to those who received a traditional egg-based trivalent vaccine 
    
• Cost-savings in using MF59-adjuvanted trivalent influenza vaccine vs. unadjuvanted trivalent vaccine for those 65 years+, where use led to a reduction in deaths and an incremental increase in quality-adjusted life years (QALY)
    
• Improved immune response in young children after repeated vaccination using MF59-adjuvanted influenza vaccine
    
• Increased immunization against influenza among young children whose parents visited doctors receiving continued medical education (CME), with parents more than 30% more likely to have their child vaccinated against influenza, and children seen by the doctor with their parents 20% more likely to receive an adjuvanted trivalent influenza vaccine.

bacteria-808158_1920 by skeeze PIXABAY Free Lic CC0

"The five studies presented at IDWeek reinforce the value of our MF59 technology in enhancing the body's immune response, reducing the burden of influenza and providing greater protection for those whose weaker immune systems mean they are at an increased risk of influenza," said Russell Basser, Senior Vice President of Research and Development at Seqirus.


SOURCE: Used by Permission of PRNewswire


Image credits: Bacteria by skeeze; TB Test by WikiImages, both at PIXABAY

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