The Replikin Count of H1N1 virus’s infectivity gene shows continued elevation

Sep 30 2009

The latest H1N1 genomic data shows a 50% drop in the Replikin Count^TM of the virus’s replikins lethality gene since its recorded highs in April 2009. In contrast, the Replikin Count of the virus’s infectivity gene showed a continued elevation. The Boston-based biotech firm Replikins Ltd. (www.replikins.com) today released the new quantitative virus data collected by the same FluForecast® software which correctly predicted the current outbreak of H1N1 in April 2008, a year before the outbreak occurred.

“In spite of the drop in the Replikin Count of the H1N1 lethality gene, followed by a drop in mortality rate worldwide, the Count remains 20% elevated compared to its resting levels between 1934 and 2008. This means there are still rapidly replicating individual viruses within the currently circulating H1N1 virus population that contain high Replikin Counts in their lethality genes. In previous virus outbreaks these high counts were associated with high mortality. With the persistent high infectivity, the risk of serious disease therefore remains,” explained Samuel Bogoch, MD PhD, chairman of Replikins Ltd. The FluForecast^® virus structural data typically provides a three-month to one-year prediction of the course of the clinical manifestations of the viral outbreak.

In the CDC Weekly reports, weeks 36 and 37, ending September 12^th and 19^th, 2009, the number of influenza-associated pediatric deaths, which peaked in June, 2009 following the peak Replikin Count of the Lethality Gene of April, 2009, have now decreased following the decrease in the Count. The number of pediatric deaths thus followed the rise and fall of the Replikin Count of the Lethality Gene (Figure).

In contrast, with noteworthy reproducibility of the method, as of September 29, 2009, the Infectivity Gene Count has remained elevated, decreasing only 3% in its mean since its high in April 2009, thus giving no significant sign of an abatement, as compared to SARS when a sharp drop in the Replikin Count of the spike protein in the year of the outbreak, 2003, signaled the abrupt end of the clinical outbreak.

Possible H5N1 – H1N1 combination

As in H1N1, the replikins in H5N1 (“Bird Flu”) were found not to be distributed evenly throughout the genome but to be concentrated in the same two areas as in H1N1, and associated with lethality and infectivity. Clinically, H1N1 has high infectivity and low lethality, the opposite of H5N1, which has low infectivity and high lethality; and the Replikin Counts correspond exactly to the clinical characteristics of each strain. H5N1 lethality in humans has reached 80% in recent outbreaks.

Because of the known ability of segments of the genomic sequences to transfer between influenza strains, the possibility that the high infectivity of H1N1 might be combined with the high lethality of H5N1 is of concern, and it appears that there is no method available to predict the probability of this occurrence.

Replikins TransFlu^TM Vaccine

To prepare in advance for the possibility of an H1N1-H5N1 combination occurring, a synthetic replikin vaccine named Replikins TransFlu^TM has been developed by Replikins, Ltd. This vaccine is based on identical replikin structures shared in the common A Influenza strains, H1N1, H5N1, H9N2, and H3N2.

TransFlu Vaccine testing has begun, and the vaccine is available to institutions worldwide for further testing. A recent blind test at the University of Georgia of replikins TransFlu^TM vaccine was successful against H5N1 in chickens (see below). and tests against H1N1 and H5N2 are following. Consumption of virus excretions by neighboring chickens is a major mechanism by which influenza reservoirs are maintained both in Asia and North America; this constant transfer could not be blocked by previous massive vaccine efforts in China.

In the recent peer-reviewed publication by Jackwood et al (Avian Diseases, Publication Online: doi: 10.1637/8892-042509-ResNote.1), synthetic Replikins TransFlu^TM vaccine, produced in 7 days, was shown to be effective in decreasing infectivity and completely blocking excretion of LPAI H5N1 in chickens.

The publication concludes: “Taken together, these data indicate that a replikin peptide vaccine specifically made against the H5N1 Black Duck/NC/674-964/06 and administered 3 times to the upper-respiratory tract, was capable of protecting chickens from infection and shedding of the homologous virus, which is extremely important because reduced virus shedding and transmission decreases the potential for H5 LPAI viruses to become HPAI viruses. The study is also important because it shows that the vaccine can be effectively mass delivered to the upper-respiratory tract.”

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