H3N2v Vaccine Clinical Trials

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Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations

This is a Phase II open-label study in approximately 200, and up to 240, healthy males and non-pregnant females, aged 18 years and older. This study is designed to assess the safety, reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by Sanofi Pasteur. Subjects will be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120) subjects >/= 65 years old) to receive two doses of vaccine, delivered intramuscularly as 15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be approximately 7 months.

Locations
<table class="layout_table indent2" border="0" cellpadding="0" cellspacing="0"> <tbody><tr><td colspan="2" class="header3" style="padding-top:2ex" nowrap="nowrap">United States, Georgia</td></tr> <tr> <td style="padding:1ex 1em 0px 2em" nowrap="nowrap">Emory Vaccine Center - The Hope Clinic</td> <td class="header3" style="padding:1ex 0px 0px 2em" nowrap="nowrap">Recruiting</td> </tr> <tr><td colspan="2" style="padding-left:4em" nowrap="nowrap">Decatur, Georgia, United States, 30030-2517 </td></tr> <tr><td colspan="2" class="header3" style="padding-top:2ex" nowrap="nowrap">United States, Iowa</td></tr> <tr> <td style="padding:1ex 1em 0px 2em" nowrap="nowrap">University of Iowa - Infectious Disease Clinic</td> <td class="header3" style="padding:1ex 0px 0px 2em" nowrap="nowrap">Recruiting</td> </tr> <tr><td colspan="2" style="padding-left:4em" nowrap="nowrap">Iowa City, Iowa, United States, 52242-1009 </td></tr> <tr><td colspan="2" class="header3" style="padding-top:2ex" nowrap="nowrap">United States, Texas</td></tr> <tr> <td style="padding:1ex 1em 0px 2em" nowrap="nowrap">Baylor College of Medicine - Molecular Virology and Microbiology</td> <td class="header3" style="padding:1ex 0px 0px 2em" nowrap="nowrap">Recruiting</td> </tr> <tr><td colspan="2" style="padding-left:4em" nowrap="nowrap">Houston, Texas, United States, 77030-3411 </td></tr> <tr><td colspan="2" class="header3" style="padding-top:2ex" nowrap="nowrap">United States, Washington</td></tr> <tr> <td style="padding:1ex 1em 0px 2em" nowrap="nowrap">Group Health Research Institute - Seattle</td> <td class="header3" style="padding:1ex 0px 0px 2em" nowrap="nowrap">Recruiting</td> </tr> <tr><td colspan="2" style="padding-left:4em" nowrap="nowrap">Seattle, Washington, United States, 98101-1466 </td></tr> </tbody></table>
More info at: http://www.clinicaltrials.gov/ct2/show/NCT01746082?term=NCT01746082&rank=1

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Re: H3N2v Vaccine Clinical Trials

NIH launches H3N2v flu vaccine study

Woodruff Health Sciences Center | Jan. 23, 2013

The Hope Clinic of the Emory Vaccine Center is one of four U.S. centers participating in a national clinical study of an H3N2v influenza vaccine in healthy adults and elderly individuals.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring the study through four NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs): Emory Vaccine Center, Baylor College of Medicine, University of Iowa, and the Group Health Research Institute in Seattle. Principal investigator is Wendy A. Keitel, MD of Baylor.

H3N2 influenza viruses typically circulate in swine, but variants ?denoted with the letter "v"? sometimes circulate in people. In July 2011, an H3N2 variant containing genetic material from the 2009 H1N1 influenza virus was discovered in patients with flu-like symptoms. Since that time, there have been 321 confirmed cases of human infection with this H3N2v virus.
Most of these infections have been associated with direct and prolonged exposure to pigs at agricultural fairs, although some person-to-person transmission has occurred. Symptoms of H3N2v infection are similar to those of seasonal influenza: fever and respiratory symptoms (such as cough and runny nose), sometimes with body aches, nausea, vomiting or diarrhea.

"We are pleased to be participating in this important national clinical trial," says Sri Edupuganti, MD, principal investigator at the Emory Hope Clinic. "It is very important to be prepared for potentially challenging outbreaks of flu variants, especially when they appear to spread easily between humans and animals." . . . .

http://news.emory.edu/stories/2013/01/h3n2_flu_vaccine_study/index.html

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Re: H3N2v Vaccine Clinical Trials

UIHC Tests New Flu Vaccine

By Jill Kasparie, Reporter
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IOWA CITY, Iowa - Doctors are waging a battle against a new flu virus.

Researchers at the University of Iowa Hospitals and Clinics are taking part in a clinical trial to test a new vaccine for the H3N2 Variant flu virus. It?s a virus that?s similar to the H1N1 virus from 2009.

In the past two years, some people have come down with this strain of the flu who were exposured to pig displays at agricultural fairs. Doctors mostly saw the cases in the summer.

Health experts are working on this vaccine because this virus seemingly spreads more easily to people from swine than other viruses like it.

For Mary Ann Lewis, taking part in studies at the University of Iowa Hospitals and Clinics is nothing new. This is the third time she's taken part in a flu vaccine study. She's one of fifty local participants in the clinical trial, and doctors are watching her response to the new vaccine. The Fairfax woman just got her first of two doses.

"If I can help people in any way or in any of these studies, I think it's worthwhile,? Lewis said. . . .

http://www.kcrg.com/news/local/UIHC-Tests-New-Flu-Vaccine-187982961.html
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