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Vaccine Patch Prototype Testing

Lucy Ostrowski

Gabriella Vasquez

Sebastian Orellana

Disclaimer:​ Due to the fact that we could not physically test our prototype, we decided that the

only way to get a solid understanding of the testing would be to write a report/summary on

similar tests that have been done. We could not physically test our prototype because we would

need to simulate human skin, which we can not do with the materials we have at home. We also

spent a large amount of time researching virtual simulations that we could use to test the virtual

vaccine patch that we made, but none were found even after what felt like endless hours of

research. All results and conclusions were made by this study, and all of the credit goes to

them.

Summary of “Effect of microneedle design on pain in human subjects” by Harvinder S.

Gill, Donald D. Denson, Brett A. Burris, and Mark R. Prausnitz.

(​https://www.google.com/url?q=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917250/

&sa=D&ust=1606952264227000&usg=AOvVaw2jEi1Es4m3YUa0iIQlOVZ5​ )
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Abstract:

The hypothesis that these scientists were testing was that microneedles cause significantly less

pain than a 26-gage hypodermic needle, and that decreasing microneedle length reduces pain

in normal human subjects.

Table Of Contents

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . 2

Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Discussion . . . . . . . . . . . . . . . . . . . . . . . . . 5

Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . 5

Citations. . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Introduction:

Background-

Many people struggle with anxiety and phobias related to getting vaccinations due to the pain

caused by the hypodermic needle. Some drugs are able to be administered without a needle

with transdermal patches, but they are not as effective and can only be used with a select

amount of substances. The in-between for these two would be a microneedle patch, which is

designed to still inject the substance but cause less pain, and with that, less anxiety.

Equations-

There were no major equations in this experiment, other than converting variables, but those

were not included in the report.

In order to successfully get a larger population of people vaccinated, the following discovery

questions need to be answered.

Discovery questions-

What shape of microneedle would cause the least amount of pain to the patient receiving the
vaccination?
We hypothesize that a thinner, longer needle will cause the least amount of pain.
Within the actual microneedle, what size layer of hyaluronic acid would allow the vaccine to be
released the fastest?
What design of the microneedle affects the pain scale the most?

Methods:

These scientists tested the amount of pain caused by each needle by inserting single

microneedles with lengths ranging from 480 to 1450 μm, widths from 160 to 465 μm,thicknesses

from 30 to 100 μm and tip angles from 20° to 90° into the forearms of ten healthy, human

subjects in a double-blinded, randomized study. They recorded the amount of pain caused by

each needle with what they call “visual analog pain scores”. (Their explanation of this process: “

Each subject was presented with a ruler containing a 100-mm slot with “No Pain” written at the

left end and “Worst Pain” at the right end. There were no other markings visible to the subject.

Immediately after each insertion, the blinded subjects were asked to move the slider to the

place along with the slot that best described his or her pain. The blinded observer recorded the

location of the slider along with the slot in millimeters, which was visible on the backside of the

ruler”). They compared all of the results in order to come to a conclusion. Below is the table that

the scientists used to control the geometry of the microneedles used in this experiment.
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Results​:

After scaling the pain and comparing the information that they got, Harvinder S. Gill, Donald D. Denson,

Brett A. Burris, and Mark R. Prausnitz found that their hypothesis was correct. They concluded that

microneedles are significantly less painful than the hypodermic needle and that microneedle length affects

the pain scale of the microneedle the most, in comparison to thickness, angles, and shape. The two

graphs below show the difference between how needle length affected pain and how thickness or the

angle of the needle tip affected pain.

As you can see from the graphs, needle length affected pain much more than needle thickness

and tip angle.

Discussion:

The overall thing that I think we should take into consideration from observing this experiment is

that microneedles are in fact a foolproof method of reducing pain in vaccines. Also, I think that it

will helo up to solidify our design by making sure that the lengths of the microneedles have a

good enough balance of length to where they can hold enough vaccination to successfully

administer the drug while being short enough to fully minimize the pain.

I think that we need to look back at our design and make sure that our patch can hold the right

amount of liquid. If it holds too much, it would be smart to minimize the number of microneedles

because that would lessen the pain as well.

Conclusion:

In conclusion, the use of microneedles in substitution for regular vaccine needles results in less

pain and anxiety in patients. For example, “Using the shortest microneedles, pain scores were

reduced by a factor of 20 compared to the hypodermic needle. Overall, pain scores from the

diversity of microneedle geometries considered ranged from 5 to 40%, which was highly

significant by statistical analysis. This level of pain reduction could also be significant to reduce

needle anxiety and phobia.” On the contrary, more microneedles would be needed to administer
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vaccinations because they would need to hold a certain volume of the antibody. They found that

in order to optimize microneedle designs, shorter microneedles would be needed. “In

conclusion, this study demonstrates that microneedles over a wide range of dimensions are

significantly less painful than a 26-gage hypodermic needle and that decreasing microneedle

length and number of microneedles reduces pain. These findings give insight into the thresholds

and parameters that control pain due to micron-scale trauma to the skin and provide a rational

basis to optimize microneedle geometry for drug delivery applications that minimize pain.”

Citations:

The lab we based our conclusions off of: ​Effect of microneedle design on pain in human

subjects