Today's Top Stories
After asking for more information back in June 2010, two years later the FDA has green-lighted MenHibrix, GlaxoSmithKline's ($GSK) combination meningitis vaccine for the U.S. market. This targets infections with Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B, and is given as four doses between 6 weeks and 18 months of age. Both of these infections can cause meningitis.
This vaccine has a couple of advantages over its competitors--it is the only meningitis vaccine that can be given to children as young as 6 weeks old, Leonard Friedland, vice president of clinical and medical affairs in North America for GSK Vaccines, told FierceBiotech. It also doesn't add to the vaccination burden for these young children. "MenHibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers," Freidland said.
- read the press release from the FDA
- see GSK's release
- check out the FierceBiotech article
GSK grabs FDA nod for combo meningitis vax
GSK's Nimenrix gets green light in Europe
Read more about: FDA
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Vaccibody's lead therapeutic DNA vaccine, developed for the treatment of precancerous changes in the cervix caused by human papillomavirus (HPV) infection, is expected to move into the clinic in late 2013 once funding is in place, the company CEO Ole Henrik Brekke told FierceVaccines at BIO 2012. The trial will recruit women who are infected with HPV-16 and have cervical intraepithelial neoplasia (CIN) at grade 1 or 2.
The Norwegian vaccine company has designed the vaccine to trigger a T cell response in a single shot by targeting the dendritic cells (also known as antigen-presenting cells). The HPV vaccine is administered just under the skin or into the muscle using electroporation technology, where a small charge allows the plasmid (a small circle of coding DNA) into the cell. The genetic information then harnesses the cell's manufacturing capabilities to create the three-component protein vaccine.
"We see a higher immune response than other DNA vaccines in animal studies, and it doesn't need an adjuvant," says Brekke. "We think that this is because the vaccine molecules adhere to the dendritic cells."
Future formulations of the vaccine could use needle-free administration techniques. The technology also has potential for infectious disease and in veterinary use, as a prophylactic vaccine, and the company is in discussion with a number of potential partners, according to Brekke.
- read the company overview at BIO 2012
GeoVax: Meeting the HIV vaccine challenge
DNA vaccine swats TB and HIV
Army uses ducks and DNA vax to make antivirals
Scancell's DNA melanoma vaccine poised for Phase II
DNA vaccine for prostate cancer moves into Phase III
Read more about: prophylactic vaccines, needle-free
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Herpes simplex virus (HSV-2) infections cause recurring and painful genital sores, with the disease being most severe in people with suppressed immune systems. There is no preventive vaccine or cure, but Genocea Biosciences has a prophylactic HSV-2 vaccine moving into a first in-human clinical trial in third quarter 2012, Chip Clark, president and CEO told FierceVaccines at BIO2012. Seth Hetherington, CMO, was also at the meeting, presenting in the session "Therapeutic Vaccines Against Chronic Infectious Diseases: Vaccines versus Microbes Part 2."
The planned trial is a Phase I/IIa study, which will involve 150 otherwise healthy people with HSV-2 infection, explained Hetherington in the presentation. The trial will measure safety and immune response, and will also look at viral shedding and the frequency of and severity of recurrent genital sores. Data should be available in the third quarter of 2013, according to Hetherington.
Five years ago, Genocea Biosciences set out to create a new class of vaccines, Clark explained, which were designed to trigger a T cell response, in contrast with the traditional focus on the B cell (antibody) response. To create the HSV-2 vaccine, Genocea Biosciences screened the blood from hundreds of people who had been exposed to the virus, including people with frequent disease, infrequent disease or asymptomatic disease, using the company's high-throughput T cell antigen discovery technology: AnTigen Lead Acquisition System (ATLAS). This technology was created at The University of California at Berkeley and Harvard Medical School.
For the HSV-2 project, the ATLAS technology identified a number of proteins that are associated with protection against HSV-2 infection. The vaccine includes two of these, a T cell antigen and a B cell antigen, as well as a T cell adjuvant to increase the immune response.
The company now has five T cell-based vaccines in preclinical development, with one poised to enter the clinic, and is interested in speaking with potential collaborators.
"There is no other discovery platform for T cell vaccines," said Clark. "We are interested in speaking with potential collaborators, as we now have five vaccines in the pipeline, and that is a lot for a small company. We created these to show the versatility of the platform, and we have two vaccines against HSV-2, and vaccines against bacteria (Chlamydia trachomatis and Streptococcus pneumoniae) and protozoa (Plasmodium falciparum; malaria). These are all large targets, with lots of proteins, and we feel that ATLAS gives us a comparative advantage."
The next step will be to move the company's pneumococcal vaccine into the clinic, likely to be around the end of 2013. Because Genocea's vaccines target T cells rather than B cells, this could be used in combination with existing vaccines.
- check out the session abstract
Chlamydia vaccine protects in animal studies
Clark named CEO of Genocea
Genocea applies tech to therapeutic vaccines
Read more about: Chip Clark, Seth Hetherington
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In 2010, CSL's Fluvax seasonal flu vaccine was linked with cases of febrile convulsions (fits related to high fever) in the under-5s, and the company has presented the results of its investigations at the Public Health Association of Australia's 13th National Immunisation Conference. This follows warning letters from the FDA in 2010 and 2011, when the company was told that it needed to investigate the issues adequately. According to Bloomberg, CSL's shares fell by 1.2% on the news.
The study showed that Fluvax caused more fits in this group than at least one other licensed vaccine, but that the vaccine had not been linked with increased levels of convulsions in the past. The final conclusion from the company was that this was linked to the levels of virus components in the end product, rather than it being a problem with manufacturing, and that the increased levels of fits must be related to characteristics of the virus unique to the 2010 strain.
Dr Darryl Maher, vice president of medical and research at CSL Biotherapies said: "While influenza vaccines must contain virus components to stimulate sufficient protection against influenza, it appears that components of the inactivated virus retained in Fluva in 2010 overstimulated the developing immune systems of some young children compared to previous seasons."
The company is continuing studies, and in the meantime the vaccine will remain restricted to children over 5 years. Maher added: "Influenza is a serious disease and as Australia's only on-shore manufacturer of influenza vaccine, we are committed to ensuring Fluvax is safe and effective for all age groups."
- read the press release
- see the article in Bloomberg
CSL confirms convulsions appear tied to Fluvax manufacturing
CSL confirms Fluvax manufacturing tied to convulsions in children
CSL recalling product tainted with ethylene glycol
Read more about: CSL, Fluvax
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Anthrax is a lethal disease caused by infection with the bacterium Bacillus anthracis. Its spores can lay dormant for centuries, and infection can occur through swallowing or breathing the spores, or even through the skin. These deadly characteristics make it a perfect bioterrorism weapon worthy of a spy thriller. PharmaThene, supported with federal funding, is developing an anthrax vaccine, SparVax, and is planning further Phase II trials for the second half of 2012.
In previous clinical and preclinical trials, SparVax's protection was between 90% and 100% when given on a 6- or 12-month booster dose regime. Thomas Fuerst, executive vice president and CSO commented: "SparVax has previously been evaluated in two separate Phase II clinical trials involving approximately 770 subjects. This latest Phase II trial, which we expect will commence in the second half of this year, will be a dose-ranging and schedule study designed to evaluate the safety and immunogenicity of SparVax in approximately 300 healthy subjects."
The second-generation recombinant vaccine has been manufactured to full cGMP standards using the company's E. coli-based rPA technology platform, and the trial will use the final drug product in pre-filled syringes. According to the company, this is a major step forward, with a much improved yield and more robust process, compared with the first-generation anthrax vaccine. The vaccine's development is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health and the Biomedical Advanced Research and Development Authority.
The vaccine currently used in the U.S., BioThrax from Emergent Solutions, requires 5 doses over 18 months, with annual boosters. It not clear yet what SparVax's dosing schedule could be, but the company could have an advantage if it is a shorter schedule, or requires fewer doses.
- read the press release
U.S. considers anthrax vaccine trials--for kids
Emergent BioSolutions gets gov't order for BioThrax
BARDA continues support of pre- and post-exposure anthrax vax
U.S. increases Emergent BioSolutions' anthrax vax contract
Combo anthrax/smallpox vax beats anthrax vax alone
Read more about: PharmAthene
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Human papillomavirus infection is the cause of nearly all cases of cervical cancer, and so immunizing young women before they are exposed to the virus could save a great many lives. So, the idea of a large scale clinical trial of an HPV vaccine in India seems like a valid idea, based on the country's supposed huge cervical cancer healthcare burden. Not so--according to a paper published in the Journal of the Royal Society of Medicine, the epidemiology behind the study is flawed and the trial is currently the subject of an investigation by the Indian government.
The trial was under the auspices of PATH, an international health charity, and included over 23,000 girls in the Indian states of Gujarat and Andhra Pradesh. The charity had claimed that "in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide." However, according to the study, led by Allyson Pollock of Barts and The London Medical School, the cancer surveillance, registration and monitoring in India in general, particularly in the Gujarat and Andhra Pradesh regions, were incomplete, so that it would be impossible to tell whether the vaccine would be successful in preventing the disease.
The figures that do exist for India show that there were only 22 cases of cervical cancer per 100,000 in 2004/2005 in india, falling from 43 cases per 100,000 in 1982/1983--this is around half the rate in countries like Brazil and Zimbabwe.
"This trial has clearly raised serious concerns for the people and government of India," says Pollock. "We found that current data on cervical cancer incidence do not support PATH's claim that India has a large burden of cervical cancer or its decision to roll out the vaccine program."
India does have major health burdens, for example in malaria and other infectious diseases, maternal anemia and malnutrition, and so the use of an expensive HPV vaccine, which is one of the more expensive vaccines on the market, for a health issue with a lower impact would seem to be a flawed use of limited financial resources.
- read the press release
- see the paper
GAVI Alliance could be closer to HPV vax deal
Gardasil could cut cancer in women already infected with HPV
Study: Most girls who get HPV vax say they see need to practice safe sex
Read more about: cervical cancer, India
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