WRAL Tech Wire

Quintiles working with several clients worldwide to combat H1N1

Related Blog Posts

• Quintiles forms drug research alliance with South African medical center
• Quintiles exec: H1N1 vaccine expected in October
• Senior Quintiles executive jumps to rival Kendle as chief operating officer
• In IT world, it's more than pay that keeps employees motivated, survey shows

On The Web

• Quintiles
• NEJM study
• FCC

Site Search

Get the latest news alerts: Follow LTW at Twitter.

Local Tech Wire

RESEARCH TRIANGLE PARK, N.C. – Several worldwide research efforts to create an effective vaccine against H1N1 has a strong Triangle connection – Quintiles.

Unfortunately, for the time being at least, little can be said about its role.

Quintiles did receive some recognition in a widely reported study published in New England Journal of Medicine on Friday. CSL, an Australian-based pharmaceutical firm, published early findings that indicate its vaccine could fight H1N1 with just one dose. Expectations have been for the most part that two vaccinations would be required.

In the NEJM study, CSL thanked Quintiles’ Australian subsidiary as one of the contributors to the study.

However, Quntiles’ role with other company’s efforts can’t be discussed, according to a company spokesperson. Quintiles, which employs 23,000 people across 50 countries, provides clinical trials, research and other related services to life science companies to international clients.

“We are working on several trials around the world at the moment for both H1N1 treatments and vaccines,” Phil Bridges, Quintiles’ manager of corporate communication, told Local Tech Wire.

Only CSL has granted Quintiles permission to acknowledge its H1N1 work.

Quintiles provided what bridges described as a “full scope of services” to CSL for the H1N1 vaccine trials.

Those included:

• Project Management
• Clinical Monitoring and Management
• Data Management
• Biostatistics
• Medical Writing

Quintiles is working with CSL in both the U.S. and Australia.

According to CSL, its study that found between 75 percent and 96 percent of vaccinated people should be protected with one dose - the same degree of effectiveness as the regular winter flu shot.

U.S. data to be released Friday confirm those findings, and show the protection starts rapidly, Dr. Anthony Fauci of the National Institutes of Health told The Associated Press.

"This is quite good news," Fauci said.

GlaxoSmithKline, which maintains its U.S. headquarters in the Triangle, is also working on an H1N1 vaccine. So is Novartis, which is building a vaccine plant in Holly Springs.

RTP startup AlphaVax is also developing a vaccine.

CSL’s dosage study has an important ramification, The Associated Press reported: It means people will have to line up for influenza vaccinations twice this year instead of three times - once for the regular winter flu shot and a second time to be inoculated against swine flu, what doctors call the 2009 H1N1 strain.

Thursday's swine flu vaccine reports center on adults; studies in children aren't finished yet, The AP said.

Scientists feared that people of all ages would need two shots about a month apart because the new H1N1 strain is so genetically different from normally circulating flu strains that most of the population has little if any immunity.

In the CSL study of 240 adults, half younger than 50 and half over, one shot prompted the same kind of immune response indicating protection that is seen with regular flu vaccine. And a standard 15-microgram dose - not the double dose that also was tested - was enough.

"It's really striking how incredibly similar this is to every other study of a seasonal flu vaccine I've ever seen," said Dr. John Treanor, a flu specialist at the University of Rochester who examined the data.

CSL, which is one U.S. vaccine supplier, found the same side effects in its study that people experience with regular flu vaccine, which is no surprise since this shot is merely a recipe change from the annual standby. About 45 percent of recipients had mild reactions such as a headache, sore arm or redness at the shot site.

On Friday, the NIH is set to release results of its own studies of hundreds of adults that confirm that one shot works, Fauci said.

Plus, the U.S. work shows that people are protected between eight days and 10 days after that inoculation, he said.

One dose means tight supplies of H1N1 vaccine won't be stretched so badly after all. The U.S. has ordered 195 million doses, based on the hope that 15 micrograms was indeed the right dose. Had it taken twice that dose, or two shots apiece, half as many people could have received the vaccine.

The winter flu vaccine is widely available now, and U.S. health authorities urged people Thursday to get it out of the way now before swine flu shots start arriving in mid-October.

(The Associated Press contributed to this report.)

Editor's Blog

The latest blog posts from our WRAL Tech Wire and WRAL editors. Read more articles…