New vaccine

July 8, 2008 by generic
Filed under: Vaccine Science 
Eleven years ago, Professor Adrian Lee, head of the School of Microbiology and Immunology at the University of New South Wales commented on the failure of the first Helicobacter vaccine to work in a European trial. The Astra Research Center in Boston, USA collaborated with the New South Wales University on the project. Professor Lee believed that two or three recombinant antigens, and a much more potent adjuvant were required. Not only did the first vaccine, which had only one antigen, not work, but the e. coli and cholera toxin adjuvants caused diarrhoea in the vaccine recipients.

The Helicobacter pylori vaccine was later added to the NIH “wish list”, as can be seen here:
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A new study from the Institute of Medicine (IOM) presents important information to help the research community set domestic vaccine priorities for the future. “Vaccines for the 21st Century: A Tool for Decisionmaking,” commissioned by the National Institute of Allergy and Infectious Diseases (NIAID), employs a new quantitative model to compare the cost and health benefits of developing more than two dozen different candidate vaccines, including, for the first time, therapeutic vaccines against chronic diseases.
Based on this analysis, the report divides 26 candidate vaccines into four groups, from most to least favorable for development (see page 4). But the IOM report stresses that this ranking is not a recommendation about which candidate vaccines should be developed. Rather, it provides a framework to consider along with other key factors such as technical feasibility and public health urgency when making decisions about vaccine research and development.
More Favorable
Chlamydia vaccine given to 12-year-olds.
Heliobacter pylori vaccine given to infants.
Hepatitis C virus vaccine given to infants.
Herpes simplex virus vaccine given to 12-year-olds.
Human papillomavirus vaccine given to 12-year-olds.
Melanoma therapeutic vaccine.
Mycobacterium tuberculosisvaccine given to high-risk populations.
Neisseria gonorrhoeaevaccine given to 12-year-olds.
Respiratory syncytial virus vaccine given to infants and 12-year-olds.
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It is interesting to see Reuters stating that Novartis will launch a proof of concept trial in phase 1 in 2008.

Novartis plans new anti-ulcer vaccine trial in ’08
Switzerland – LONDON, June 4 (Reuters) – Novartis AG plans to launch a proof of concept trial for its experimental vaccine against a bug that causes stomach ulcers by the end of 2008, it said on Wednesday.
The Helicobacter pylori vaccine is currently in Phase I trials and has been shown to be safe and immunogenic in early tests.
Other products in early development include a Group B Streptococcus vaccine candidate in Phase I and a vaccine against infections from Group A Streptococcus, which is due to enter Phase I trials in 2010. A pneumoccocus vaccine to cover new strains is also expected to start Phase I testing in 2010.
Yet Clinical Trials.gov shows that Novartis has already completed a Phase I trial for a new helicobactor vaccine containing three antigens, using a standard aluminium suphate as an adjuvant. Notable in this trial is the now standard use of aluminium as a control, because it’s presumed to be an inert “placebo”.

Inside Vaccines isn’t sure if Reuters has just got it wrong, or whether the completed phase I trial isn’t considered a trial. But it will be interesting to see if Novartis has ironed out some of the problems of the first trial eleven years ago, and whether or not they will take into consideration, the fact that helicobacter pylori appears to be protective against asthma.

Stomach Microbe Linked To Asthma Prevention
The stomach bacterium Helicobacter pylori, which causes stomach cancer and peptic ulcers, may not be all bad. According to a new study, it may help protect kids from asthma.
The study, based on an analysis of a health survey of 7,663 adults, showed that a virulent strain of H. pylori was especially associated with being asthma-free before the age of 15. People who carry the strain were 40 percent less likely to have had asthma at an early age than those who didn’t carry the strain. The study also found that the microbe was associated with protection against ragweed and other allergies due to pollens and molds particularly among younger adults.
The medical literature already shows that antibiotics are related (causally or not) to an increase in asthma, so maybe accidentally getting rid of helicobacter pylori in children by napalming it with antibiotics for whatever other infection, was not such a hot idea in the first place. The question will be whether putting this vaccine into the children’s schedule (or adults for that matter), just might make asthma a whole deal worse.
Will Novartis or FDA factor this into the analysis of benefit risk analysis for this vaccine?

Or will it be left to parents to ask themselves “eeny meeny miny mo, take your choice”…. that is, if they are even provided with the facts in the first place.

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Comments

2 Comments on New vaccine

  1. MinorityView on Tue, 8th Jul 2008 11:16 am

    2. Most people seem to be able to make it through their entire lives toting about H. Pylori and lots of other bugs. So why not investigate the sub-set with problems rather than trying to transform the normal flora and fauna of the unaffected majority? Seems like an obvious approach, doesn’t it? Help the sick but don’t mess with the healthy!

  2. passionlessDrone on Mon, 21st Jul 2008 5:29 am

    3. Hi –

    I just heard on NPR on Friday that a relationship has been found between decreasing levels of H Pylori and asthma/eczema/allergy based conditions. Using consecutive NHANES datasets they found a correlation; if you didn’t have H Pylori, you were more likely to develop childhood asthma.

    http://www.npr.org/templates/story/story.php?storyId=92677188

    - pD

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