Iomai Corporation strives to discover and develop vaccines and immune system stimulants which could be administered through a novel, needle-free technology called ‘Transcutaneous Immunization (TCI)’.It tried to establish that a single dose of pandemic influenza vaccine may meet the protection level. FDA recommends a pandemic vaccine which can achieve immune response levels considered protective in 70 percent or more of vaccine recipients.
It has recently announced its positive interim results of the trial among 500 subjects with the use of its immunostimulant adjuvant patch with an injected vaccine for H5N1 influenza.
The trial demonstrated a significant influence of lomai patch when it was used with a single dose of the 45-microgram H5N1 vaccine. It proved that this combination was sufficient to provide an immune response considered protective in 73 percent of those tested. This could be counted as a statistically significant improvement over those who received the H5N1 Influenza vaccine alone.
The trial tested three different dose levels of Solvay Biologicals, B.V. (Netherlands) egg-derived H5N1 influenza vaccine, the adjuvant patch and placebo. It attempted to resolve which combinations could be most effective in a two-immunization regimen, administered 21 days apart.
Data showed that majority of the subjects who were administered vaccination of 45-microgram dose in combination with the Iomai patch had been able to achieve substantial level of protection. After every dose, the subjects demonstrated significant improvement in immune response. During the trial no treatment related serious undesirable events were reported.
Out of the 500 subjects, 73% were able to achieve an HI titer of greater than 40. This level has recognized as protective and rules out the need of second vaccination. About 49 percent received the vaccine alone without a patch had an immune response which could be considered protective after the first dose and the 24 percentage point difference between the patch and no-patch groups can be taken as statistically significant.
It further saw that a second dose of both vaccine and patch further was able to significantly add to the immunogenicity; 100 % of subjects who received two 45-microgram doses of vaccine and two Iomai patches had a measurable immune response, and 94 % of subjects had immune responses considered protective.
Stanley C. Erck, President and Chief Executive Officer of Iomai proudly states that a single dose of vaccine in combination with an Iomai patches could provide a significant level of protection. The protective levels are achieved rapidly and comply with the standards.
So it can be taken as a major breakthrough for controlling an influenza pandemic as two major hindrances faced by public health officials is limited vaccine stocks and logistic difficulty of administering two vaccinations over a period of several weeks to all individuals in the face of a pandemic.
Lomai plans to test the use of patch in conjunction with other injected pandemic influenza vaccines. Patch has already been proven to be suitable for ambient temperature shipping and handling and has at least a 2-year storage shelf life. This makes it ideal for storing it in bulk and rapid distribution. The patch can be easily applied like an adhesive bandage placed at the site of the injection.
Gregory Glenn, Iomai’s Chief Scientific Officer shares that the data has clearly confirmed approach of using an adjuvant patch to improve the immune response to injected vaccines and the ability to establish strong immune systems with the help of these vaccines administered through skin. “We continue to explore ways to bring this approach to other applications in the high-value field of vaccine adjuvants,” he says.
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