Chinese report results for whole-virus H5N1 vaccine

first_imgSept 7, 2006 (CIDRAP News) – In a human trial in China, a whole-virus H5N1 avian influenza vaccine generated an immune response with a relatively low dose of antigen, suggesting that it could be used to immunize more people than may be possible with some other vaccines under development.The study, published online today in The Lancet, showed an adequate immune response in 78% of volunteers after two 10-microgram (mcg) doses of the vaccine plus an aluminum hydroxide (alum) adjuvant. That exceeds the European Union’s requirement of an acceptable response (a hemagglutinin-inhibition titer of 40 or more) in 70% of volunteers.The vaccine is made by Sinovac Biotech in Beijing, China, from an inactivated strain of H5N1 known as Vietnam/1194/2004. The report says that Sinovac was involved in designing and monitoring the study but played no role in collecting the data or writing the report.The randomized, placebo-controlled, double-blind study involved 120 adults (aged 18 to 60). They were divided into five groups of 24, with each group receiving either a placebo or 1.25, 2.5, 5, or 10 mcg of the vaccine.Each volunteer received the vaccine on the first day of the study and 28 days later. Serum samples were assessed for evidence of an immune response on days 0, 14, 28, 42, and 56.An antibody response was seen after the first injection at all dose levels. The highest response (78% seropositivity) was seen in the 10-mcg group after two doses.The investigators reported that all four doses were well tolerated, even though whole-virion vaccines are generally thought to cause more reactions than split-virion vaccines. No serious reactions were reported, and most local and systemic reactions were mild and brief. Three people dropped out of the study, and one person was excluded from the final analysis.The authors concluded that the dose required to reach an acceptable immune response was much lower than for vaccines reported in previous studies. Two reports published earlier this year described trials of a split-virus H5N1 vaccine developed by Sanofi Pasteur. The reports said two 90-mcg doses of nonadjuvanted vaccine or two 30-mcg doses of adjuvanted vaccine were required to produce the desired immune response.(In July, GlaxoSmithKline reported a good immune response in 80% of volunteers who received a dose of only 3.8 mcg of the company’s adjuvanted H5N1 vaccine. However, a full report of those findings has not yet been published.)”The manufacturing capacity for an H5N1 vaccine would increase if a whole-virion vaccine is used, because 20% to 30% of vaccine antigen is expected to be lost during the disruption process in the preparation of split-virion vaccines, according to our experience with seasonal influenza vaccine,” the Chinese researchers write.In an accompanying commentary, Iain Stephenson, MD, of the Infectious Diseases Unit at Leicester Royal Infirmary in Leicester, England, writes that the findings point up of “a potential dose-sparing approach that could be crucial for a global supply of pandemic vaccine.”He says that trial results for split-virion H5N1 vaccines have been disappointing, because within current manufacturing constraints, the two such vaccines under development would yield only enough to vaccinate 75 million to 225 million people.Though whole-virion vaccines generally produce a better immune response than split or subunit vaccines, development of whole-virion H5N1 vaccines has been delayed, Stephenson writes. He says it is difficult for manufacturers that produce split seasonal vaccines to switch production approaches and processing methods.Stephenson cautions that whole-virion vaccines have been associated with febrile reactions in children and emphasizes that careful investigation is needed before such vaccines can be widely used.It remains to be seen whether whole-virion vaccines can induce the broad cross-reactive response that would be needed to treat a variety of H5N1 viruses, Stephenson writes.Lin J, Zhang J, Dong X, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase 1 randomised controlled trial. Lancet 2006 (early online publication, Sep 7) [Abstract (registration required)]Stephenson I. H5N1 vaccines: how prepared are we for a pandemic? (Commentary). Lancet 2006 (early online publication, Sep 7)See also:May 12 CIDRAP News story “Sanofi reports results for H5N1 vaccine with adjuvant”Jul 26 CIDRAP News story “Glaxo says its H5N1 vaccine works at low dose”last_img read more

See More

UPDATED: FCC investigating AT&T 911 outage

first_imgAware of issue affecting some calls to 911 for wireless customers. Working to resolve ASAP. We apologize to those affected.— AT&T (@ATT) March 9, 2017The Federal Communications Commission said it will investigate the cause of the outage that affected customers nationwide.BATESVILLE, Ind. — AT&T has reported a phone outage that is affecting 911 phone calls across the nation including Indiana.Ripley County communications said that AT&T sent them an automated message stating that 911 calls could be intermittent, but that the main issue would be with location services.If you are an AT&T customer and try to call 911 and can’t get through or get a busy tone, try the 10 digit phone number for your area listed below.Ripley County Dispatch – 812-689-5555Decatur County Dispatch – 812-222-4922Franklin County Dispatch – 765-647-4178Dearborn County Dispatch – 812-537-3431 UPDATE: AT&T says they have resolved the issue affecting 911 calls Wednesday night.Issue has been resolved that affected some calls to 911 from wireless customers. We apologize to those who were affected.— AT&T (@ATT) March 9, 2017last_img read more

See More

Derby winner Always Dreaming heading to Preakness early

first_img(THE Sports Xchange) – Always Dreaming, coming off an impressive win at the Kentucky Derby, will get an early start on preparations for the May 20 Preakness.The colt is expected to arrive at Pimlico Race Course in Baltimore this morning, hoping to avoid some early struggles adjusting to Churchill Downs when he arrived in Kentucky.Always Dreaming ran through a soggy track to win the Kentucky Derby by 2 3/4 lengths on Saturday, giving trainer Todd Pletcher and jockey John Velazquez their second victories in the race but their first together.Always Dreaming opened a clear lead in the stretch and finished the 1 1/4 miles in 2 minutes 3.59 seconds. He paid $11.40 as the 9-2 favourite.“It feels awesome,” Pletcher told the Baltimore Sun on Sunday. “I think it’s still sinking in. The first one’s special but this one is just as good or even better. We felt coming in we had a good chance and we had some anxious moments during the week. But we were just happy to see him deliver the performance we felt he was capable of.”Pletcher had to make adjustments with the workouts leading up to the Derby as Always Dreaming refused to relax.The trainer has decided to give the champion almost two weeks to adjust to Pimlico. Pletcher said Always Dreaming will gallop daily at Pimlico rather than a harder, timed workout.“He was so headstrong when he got here (for the Derby) that I don’t think staying here for another week is going to be an advantage,” Pletcher said. “I don’t think going to Belmont for a week and then moving again is an advantage.So just looking at what the options are, I think Pimlico, there aren’t usually a lot of horses training there, and it’ll be a quiet environment. It’ll give us time to settle in and if we need to, make any adjustments.”Pletcher is winless in eight attempts at the Preakness. His previous Derby winner, Super Saver, finished a disappointing eighth at Pimlico in 2010.The field for the 142nd Preakness is already taking shape.Derby runner-up Lookin At Lee is “definitely a possibility” to run, trainer Steve Asmussen said.Classic Empire, the morning-line favourite and fourth-place finisher in the Derby, was bothered by a swollen right eye, trainer Mark Casse said, adding if the condition doesn’t linger, he will strongly consider a shot at the Preakness.last_img read more

See More