News Scan for Apr 03, 2015

Equine glanders in Texas
Ebola vaccine trial challenges

Glanders detected in donkey near Texas-Mexico border

A stray donkey that crossed from Mexico into Texas has tested positive for glanders, a highly contagious disease that primarily affects equines, the Southwest Farm Press reported this week.

The bacterium that causes glanders, Burkholderia mallei, has been classified by the US government as a category B bioterror agent, meaning it can be transmitted fairly easily but has a lower mortality rate than a category A agent.

The Texas Animal Health Commission (TAHC) reported that a mounted US Department of Agriculture (USDA) inspector corralled five Mexican donkeys just north of Presidio, Tex., near the Rio Grande, according to the story. The animals were isolated in USDA holding pens in Presidio, and one of them later tested positive for glanders.

"It is imperative that we remain vigilant in protecting our borders from disease intrusions such as Glanders," said Dee Ellis, DVM, state veterinarian and TAHC director, told the newspaper. "Early detection of Glanders and the immediate quarantine of these donkeys was critical in preventing and protecting against the spread of this foreign disease."

The TAHC is working closely with the USDA to monitor the situation along the border, the story said. Equine glanders was eliminated from the United States in 1942, and the last human case in the country was in 1934.
Apr 1 Southwest Farm Press story
glanders overview


Experts weigh research challenges in Ebola countries

Two groups of infectious disease experts today addressed the challenges researchers face in doing efficacy trials in the face of waning Ebola levels in the outbreak countries, the options for addressing the problems, and the benefits of working out the study design issues now and for future outbreaks. The opinion pieces appeared in The Lancet and Science.

In the Lancet article, David Heymann, MD, a global health and infectious disease expert with the London School of Hygiene and Tropical Medicine, and two other colleagues from Europe discussed options for moving the Ebola vaccine forward if phase 3 studies stall, due to dropping disease levels.

They suggested that the study plans can be put on hold until an outbreak situation emerges. In the meantime, they wrote, authorities can work on a regulatory pathway that could consider accelerated approval based for the time being on safety and immunogenicity rather than on efficacy. The process could also include conducting studies on toxicology, defining the functional relationship between immune responses in people and in nonhuman primates, and reaching an agreement to pin down efficacy later.

The experts contended that the steps would encourages groups to stockpile the vaccine and manufacturers to produce it, which would help ensure that a vaccine supply would be available for quick deployment to outbreak hot spots to complete efficacy trials.
Apr 3 Lancet commentary

In the Science editorial, Marc Lipsitch, PhD, director of the Center for Communicable Disease Dynamics at the Harvard School of Public Health, and colleagues wrote that the challenges researchers are facing in doing efficacy studies in the outbreak region would probably be faced when developing vaccines for other emerging infectious diseases. They suggested three principles that are used to some degree in current Ebola vaccine trial designs that could be used to guide vaccine planning in other health emergencies.

Principles include block randomization within small centers, with analysis matched by center, stepped rollout, and adaptive design.

The authors observed that researchers are faced with balancing the epidemiology of the disease with the characteristics of the vaccines. They said that the ethics of speeding a vaccine to many people should be weighed with the need to evaluate efficacy.

Discussions take time against the backdrop of the need for expediency, they wrote. "The more such discussions can take place outside emergencies and establish general principles to inform vaccine trial designs in future outbreaks, the more effective the responses to such outbreaks will be."
Apr 3 Science commentary

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