News Scan for Jul 01, 2015

National Ebola center
H pylori vaccine tests well
Pandemrix-narcolepsy study

HHS opens national Ebola training, education center

Today the US Department of Health and Human Services (HHS) announced the launch of a national center to help healthcare providers and facilities prepare for, transport, and treat patients with Ebola and other emerging disease threats, the agency said in a news release.

The National Ebola Training and Education Center is a collaborative effort involving HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR), the Centers for Disease Control and Prevention (CDC), and three academic institutions: Emory University in Atlanta, the University of Nebraska Medical Center/Nebraska Medicine in Omaha, and Bellevue Hospital Center in New York City.

ASPR and the CDC will provide $12 million over the next 5 years to the three institutions to support the center.

Emory University and Nebraska Medical Center have been working with the CDC since December to train more than 460 health care workers from 87 health care systems, including 37 designated Ebola treatment centers, on Ebola infection control and patient care, HHS said. The two institutions are offering additional training this summer for up to 400 professionals from Ebola assessment hospitals.

The new national center will expand on these initial efforts and offer clinical expertise to state health departments and healthcare facilities. HHS recently announced 9 regional Ebola treatment centers with enhanced capabilities that are part of a national network of 55 Ebola treatment centers.
Jul 1 HHS news release
Jun 12 CIDRAP News scan on 9 regional centers


H pylori vaccine shows 70% effectiveness in large phase 3 trial

A new vaccine against Helicobacter pylori, a major cause of peptic ulcers and gastric cancer, achieved better than 70% effectiveness in a large phase 3 trial in China, according to a report published yesterday in The Lancet.

The trial, launched in December 2004, involved a three-dose recombinant oral vaccine composed of a part of H pylori urease and a toxin produced by Escherichia coli. The researchers randomly assigned 4,464 healthy children aged 6 to 15 years, with no history of H pylori infection, to receive the vaccine or a placebo.

In the first year of the trial, 14 H pylori infections occurred among 2,199 vaccinated children, versus 50 infections among 2,204 children in the placebo group, resulting in a vaccine efficacy of 71.8% (95% confidence interval, 48.2%–85.6%). Among children who were followed for 2 more years, vaccine effectiveness was estimated at 55%, suggesting continued but reduced protection.

As for safety, 7% of participants in both the vaccine and placebo groups reported at least one adverse reaction. Serious adverse events were reported in less than 1% of both groups, but none were believed to be vaccine-related.

In an accompanying editorial, Philip Sutton, PhD, of Murdoch Children's Research Institute in Parkville, Australia, says an effective H pylori vaccine is needed most for preventing gastric adenocarcinoma, the third leading cause of cancer-related death worldwide. He calls the findings "a major advance" after years of disappointment in the quest for such a vaccine.

Sutton says the trial achieves several important firsts in the H pylori vaccine realm, including the first large phase 3 study, the first to include several years of follow-up, and the first to involve children. He notes that H pylori infection typically occurs in childhood.

But he cautions that several challenges remain, including the requirement to precede the oral vaccine with a bicarbonate solution, a potential risk related to the use of the E coli toxin, and the signs of waning protection after the first year.
Jun 30 Lancet abstract
Jun 30 Lancet editorial introduction


Immune-response study sheds light on narcolepsy and flu vaccines

Narcolepsy associated with GSK's 2009 H1N1 vaccine Pandemrix might be the result of an immune response associated with vaccine nucleoprotein content, according to a small study in Science Translational Medicine today comparing Pandemrix and Novartis's Focetria vaccine.

The authors call the phenomenon a "hit-and-run" autoimmune response, according to a Stanford University press release.

An international team sought to determine why Pandemrix was associated with narcolepsy while Focetria was not, and why only patients in certain countries, such as Finland, Sweden, Denmark, and Ireland. Noting that narcoleptic patients have very low levels of the neurotransmitter hypocretin, which aids in sleep-wake cycles, they assessed levels of the hormone in recipients of the two vaccines.

Among 20 Pandemrix recipients, 17 had elevated antibodies to the hypocretin receptor. Among six immunized with Focetria, however, none had these antibodies.

The researchers also identified a mimic peptide on a region of 2009 H1N1 nucleoprotein A that had similar properties as the hypocretin receptor. And Focetria contains 72% less of this nucleoprotein than does Pandemrix, according to the authors.

The investigators propose a hit-and-run autoimmune mechanism for how both 2009 H1N1 flu and Pandemrix might cause narcolepsy. They suggest that high levels of the H1N1 nucleoprotein stimulate production of large amounts of antibodies to both the virus and the hypocretin receptor in susceptible people. If these antibodies enter the brain, they may latch onto hypocretin receptors, possibly directing the immune system to destroy or suppress brain cells critical to regulating sleep-wake cycles.

The study's first author is Sohail Ahmed, MD, who was global head of clinical sciences at Novartis Vaccines at the time of the study.
Jul 1 Sci Transl Med abstract
Jul 1 Stanford University press release

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