The Use of New Replikins Synthetic Vaccines to Prevent Pandemics to be Presented at Influenza Congress Nov. 12 in Washington DC

LONDON, Nov. 6, 2012 /PRNewswire/ -- In the lead paper to be presented at the Influenza Congress USA in Washington DC on November 12, 2012, Dr. Samuel Bogoch of Bioradar UK Ltd. will discuss how new synthetic Replikin vaccines may prevent the development of influenza virus outbreaks and pandemics. Pandemic prevention, not previously possible, is being considered for the first time because quantitative changes in Replikins^® in the virus genome have been shown to predict strain-specific outbreaks and the particular geographic locations where outbreaks will occur (1-5).       

(Photo: http://photos.prnewswire.com/prnh/20121106/PH07162-INFO )           

The H1N1 pandemic of 2009 was predicted one year in advance by observing an increased Replikin^®Count. Currently, the human lethality rate of H5N1 has increased to its highest level ever, as predicted by the increasing Replikin^®Count of the p B1 'Lethality' Gene (1) as well as clinically (Figure).

The H5N1 virus previously has not been very infectious and has not spread easily to humans. (WHO total of 566 human cases since 2003.) However, in 2010, the Replikin^®Count of the HA 'Infectivity' gene of H5N1 increased (2) predicting the outbreaks which have occurred in Cambodia and Vietnam in 2011-12 (1). In 2011 the Count has increased further to its highest level since the discovery of H5N1 in 1959 (p<0.001) (Figure).

Thus the risk of further H5N1 outbreaks, and in a more infectious and more lethal form, appears also to have increased in view of the demonstrated relationship of rising genomic Replikin^®Counts to clinical outbreaks (1-5). This information is being used to synthesize current Replikins synthetic TransFlu™(including H5N1) vaccine. The data suggests that any vaccines, which might be active against H5N1, should be produced and tested as soon as possible.

Methods

The methods have been detailed in references 1-4. All 4,588 HA gene sequences and 3,163 p B1 gene sequences reported in the Pubmed data base from 2003 to 2011 were analyzed for Replikin peptides.

Results

HA Gene

The Figure shows that in 2001, bird and human H5N1 virus HA genes, had a high concentration or Replikin Count (greater than 4.0 Replikins per 100 amino acids) (Replikin Count=number of Replikins per 100 amino acids) which comprised 60% of the Replikins of the total H5N1 population. Low Counts (4.0 and below) are associated with 'resting' non-outbreak states of the virus (4). This concentration decreased after 2001 to only 20% in 2009. Then in 2010, more H5N1 HA genes had higher Replikin Counts. By 2011, H5N1 HA genes with Replikin Counts greater than 4.0 now have been found to comprise 82% of the total H5N1 population, the highest such concentration ever found.

p B1 Gene

Similarly, the Figure shows that the p B1 gene 'high' Replikin Count increased almost four-fold from 2001 to 2010, two-fold from 2009 to 2010, and peaked one year before outbreaks in Cambodia and Vietnam. In influenza, increasing Replikin Counts at p<0.001 have been followed by an outbreak in seven of seven previous Replikins prediction trials, including two for H5N1 (4).

In addition, not shown separately in the Figure, in 2011, human H5N1 Mean Replikin Counts also peaked; HA Mean Counts were 4.9(+/-0.8), and p B1 Mean Counts  12.7(+/-15.1).

The following pattern has now repeatedly been observed: genomic Replikin Counts increase to high levels, accompanied by sporadic lethal human cases, as recently seen in Cambodia (1), followed by an outbreak of rapidly replicating spreading lethal human disease, as in the H1N1 pandemic of 2009, which Replikins predicted in 2008, and in six other correct predictions in influenza made one to two years in advance (4, 5).

The geographic locations of these outbreaks were also specified in the predictions, as in the lethal outbreaks of H5N1 in 2006 in Indonesia, and currently in Cambodia. Similarly in viruses other than influenza, the highest Replikin Counts in Foot and Mouth Disease (FMD) virus in 52 years (2) predicted one year in advance the current outbreaks of FMD in Asia and the Middle East. With rapid replication and the replacement of low Replikin Count with high Replikin Count viruses, the H5N1 virus population is now 'charged' for delivery to additional hosts.

Time is Provided

Prediction permits the possibility of prevention. The observation of increasing Replikin Counts provides previously unavailable time to prepare an optimal public health response, time to prepare vaccines and other therapies specific to the oncoming organism, in sufficient quantity, and time adequately to test and distribute the vaccine before the hit-and-run outbreak has begun to disappear as happened in 2009 (2-4). Knowing the probable geographic site of onset makes vaccine coverage more practicable especially if intense and sufficiently in advance of the outbreak.

Synthetic Vaccines

Because of the Replikins technology of advanced warning, new Replikins synthetic vaccines can be produced quickly, and provide distinct advantages over traditional vaccines. Advantages include: 1. The ability to tailor the vaccine to the specific Replikins in the threatening organism, 2. Solid-phase synthesized completely free of biologicals, thus containing no bio-contaminants, 3. Synthesized in seven days instead of eight months. 4. Effective (6) when shipped freeze-dried, not requiring refrigeration and 5) the Cost per person is estimated to be 10 cents compared to $11 for biological vaccines used in the 2009 pandemic (USA, GAO)

Synthetic Replikins TransFlu™Vaccine was successfully tested independently as described in ref 6 and is now available for additional testing by government health agencies and medical schools.

Contact: Dr. Samuel Bogoch,  646-320-5910
http://www.replikins.com/quoterequest3.html

References:

1. Bogoch, S. and Bogoch, E.S. Marked Rise in Replikin Counts in H5N1 Influenza Virus Localized to Lethality Gene p B1.Nature Precedings doi:10.1038/npre.2011.6420.1

2. Bogoch, S. and Bogoch, E.S. Genome Replikin Count™ Predicts Increased Infectivity/Lethality of Viruses. Nature Precedings npre20127144. O4April 2012. 


3. Bogoch, S. and Bogoch, E.S. Prediction of specific virus outbreaks made from the increased concentration of a new class of virus genomic peptides, replikins. Nature Precedings doi:10.1038/npre.2011.6279.1.23Aug 2011. 


4. Bogoch,S. and Bogoch, ES. Bogoch Replikins Pandemic Prevention: Increase of Strain-Specific Influenza Genomic Replikin Counts, Having Predicted Outbreaks and their Location Seven Times Consecutively, Up to Two Years in Advance, Provides Time for Prevention of Pandemics. Nature Precedings.doi:10.1038/npre.2012.6952.1 01 March, 2012 


5. UN Food and Agriculture Organization (FAO) discussion of Replikins, DVM Newsmagazine, (Sept. 8, 2011). Reproduced in Report #42 , Replikins.com.

6. Jackwood, MW et al. Efficacy of a Replikin Peptide Vaccine against Low Pathogenicity Avian Influenza H5 Virus. Avian Diseases 53(4): 613‐617, 2009

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