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Flu virus-like particles elicit broader immune.....

sharon sanders

sharon sanders

Editor-in-Chief & President
<dl class="PubmedArticle" id="dlPubmedArticle17337102"><dd class="abstract" id="abstract17337102">Influenza virus-like particles elicit broader immune responses than whole virion inactivated influenza virus or recombinant hemagglutinin.

Novavax, Inc., Rockville, MD, USA.
</dd><dd class="abstract" id="abstract17337102">

Influenza virus is a highly infectious respiratory pathogen that results in severe morbidity and mortality. The current licensed trivalent vaccine formulations in the U.S. are made from virus grown in allantoic fluid from infected hen eggs that is then chemically inactivated and split into subunit components. These vaccines elicit antibodies, primarily to the viral hemagglutinin (HA), which are efficacious in healthy adults, but are limited in protecting high risk individuals, such as the elderly and immunocompromised. To address the need for improved influenza vaccines and the limitations of egg-based manufacturing, we have engineered an influenza virus-like particle (VLP) as a new generation of non-egg or non-mammalian cell culture-based candidate vaccine against influenza infection. VLPs, based on the A/Fujian/411/2002 (H3N2) isolate, were purified from the supernatants of Spodoptera frugiperda Sf9 insect cells following infection of baculovirus vectors encoding an expression cassette comprised of only three influenza virus structural proteins, hemagglutinin (HA), neuraminidase (NA), and matrix (M1). Mice or ferrets were vaccinated intramuscularly with VLPs in a dose sparing experiment, based on HA concentration (3mug-24ng), and the immune responses were compared to responses elicited in animals vaccinated with recombinant HA (rHA) or inactivated whole influenza virions (WIV). All vaccinated animals had high titer anti-HA antibodies regardless of the vaccine immunogen and animals vaccinated with the highest doses of VLPs (3mug and 600ng) also had antibodies against NA. Purified rHA elicited primarily IgG1 antibodies, which is indicative of a T helper (Th) type 2 response, whereas mice vaccinated with the VLPs or WIV were associated with a dominant Th1 immune response (IgG2a and IgG2b). Interestingly, VLPs elicited antibodies that recognized a broader panel of antigenically distinct H3N2 viral isolates compared to rHA or WIV in a hemagglutination-inhibition (HAI) assay.
PMID: 17337102 [PubMed - in process]
</dd></dl>http://www.ncbi.nlm.nih.gov/entrez/..._uids=17337102&query_hl=2&itool=pubmed_docsum
 
Re: Flu virus-like particles elicit broader immune.....

Novavax Says Vaccine Protects Against Deadly Bird Flu (Update1)

By David Olmos

Aug. 26 (Bloomberg) --

Novavax Inc. said its experimental vaccine spurred an immune response in humans that can protect against a deadly strain of bird flu linked to more than 100 deaths.

In the study, 160 patients each received two injections, in doses ranging from 15 to 90 micrograms. At the highest dose, the vaccine produced a response against one version of the lethal H5N1 bird flu in 94 percent of patients, Novavax said in a statement today.

Novavax, based in Rockville, Maryland, has been working with General Electric Co. to develop a vaccine that can be mass- produced quickly.

Outbreaks of lethal avian flu have spread from birds to humans in 15 countries, mostly in Asia, and are ``not expected to diminish significantly in the short term,'' according to the U.S. Centers for Disease Control and Prevention's Web site.

``What we've shown in this study is that the vaccine is immunogenic in humans,'' said Rahul Singhvi, Novavax's president and chief executive officer, in an interview.

``It will allow countries around the world to produce a custom vaccine on demand within their own borders.''

Novavax rose 4 cents, or 1.4 percent, to $3.01 at 9:50 a.m. in Nasdaq Stock Market composite trading. General Electric fell 9 cents, or less than a percent, to $28.23.

There have been 385 confirmed cases of bird flu in humans, resulting in 243 deaths, from late 2003 through June 19 -- the latest data available -- according to the World Health Organization's Web site.

The study involved what is known as the Indonesian strain of H5N1. That version has accounted for 135 cases, mostly fatal, of avian flu in humans, according to Novavax.

Insect Cell Cultures
Novavax's process, which uses insect-cell cultures, avoids the need to grow viruses in eggs by making vaccines from particles that mimic viruses.

With its process, Novavax can produce seven to 10 times as much vaccine in the same time as techniques that rely on eggs or cells from mammals, the company said. Novavax said it can make vaccine within 10 to 12 weeks of identifying a strain.

``This data milestone marks good progress in the viability of Novavax's vaccine,'' said Peter Ehrenheim, president and chief executive of life sciences for GE Healthcare, based in Chalfont St. Giles, England, near London, in a statement.

Other drug companies, including GlaxoSmithKline Plc and Sanofi-Aventis SA, are developing vaccines that could be produced rapidly during a flu pandemic. Traditional flu shots are made in chicken eggs, a process that can take up to six months after a strain of the virus is identified. Scientists have predicted that an avian flu strain could spread across the globe within days.

Safe to Continue
``The data are encouraging that this new vaccine approach can help prevent pandemic influenza,'' said Robert B. Belshe, an immunologist and infectious disease specialist at the Saint Louis University School of Medicine, who served on an independent safety monitoring board for the study, in a statement.

No ``serious'' side effects have been reported for the Novavax vaccine study and an independent monitoring board has supported continuing the study, Novavax said in its statement. Complete safety data for the study aren't yet available, the company said.

Novavax also is conducting two preliminary studies of a vaccine for seasonal influenza, which causes more than 500,000 deaths worldwide annually. One of the studies will test the vaccine on healthy young adults and another on people age 65 and over. Results of those studies are expected in late 2008 or early 2009.

To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net.

Last Updated: August 26, 2008 09:53 EDT
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http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ayVqFhNnlhvk
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