Bacillus Calmette-Guérin vaccination using a microneedle patch

Abstract

Tuberculosis (TB) caused by Mycobacterium tuberculosis continues to be a leading cause of mortality among bacterial diseases, and the bacillus Calmette-Guerin (BCG) is the only licensed vaccine for human use against this disease. TB prevention and control would benefit from an improved method of BCG vaccination that simplifies logistics and eliminates dangers posed by hypodermic needles without compromising immunogenicity. Here, we report the design and engineering of a BCG-coated microneedle vaccine patch for a simple and improved intradermal delivery of the vaccine. The microneedle vaccine patch induced a robust cell-mediated immune response in both the lungs and spleen of guinea pigs. The response was comparable to the traditional hypodermic needle based intradermal BCG vaccination and was characterized by a strong antigen specific lymphocyte proliferation and IFN-γ levels with high frequencies of CD4+IFN-γ+, CD4+TNF-α+ and CD4+IFN-γ+TNF-α+ T cells. The BCG-coated microneedle vaccine patch was highly immunogenic in guinea pigs and supports further exploration of this new technology as a simpler, safer, and compliant vaccination that could facilitate increased coverage, especially in developing countries that lack adequate healthcare infrastructure.

The History of Tuberculosis and Bacillus Calmette–Guérin Vaccine in Iran

“…However, mass vaccination with BCG has also been implicated as a selective force in the emergence of new pathogenic Mtb genotypes (15). The vaccine has traditionally been given intradermally, while recent refinements involving 'needle-free' vaccine patches may offer prospects for increased vaccine coverage without compromising immunogenicity (16). There are different rates of BCG efficacy in different parts of the world from 0 to 80% (17).…”

The success of microneedle-mediated vaccine delivery into skin

“…Solid MNs are pre-coated with a vaccine in a formulation suitable for coating and dissolution, 1 80 West Nile virus, 80 rotavirus, 81 herpes simplex virus 82 and hepatitis C 83 in mice, influenza virus 84 and bacillus Calmette-Gu erin in guinea pigs, 85 hepatitis B virus in pigs, 86 and measles 87 and polio 88 viruses in rats. This literature search did not reveal any clinical trials pertaining to vaccine delivery via coated microneedles.…”

Polio Vaccines: Present and Future

“…Таким образом, внутрикожное введение является приемлемым ва-риантом вакцинации, которую можно осуществлять при помощи устройств для безыгольного введе-ния. Альтернативным вариантом внутрикожного введения является использование «микроиголь-ных пластырей» [130][131][132][133]. Эти небольшие устрой-ства имеют множество растворимых пластиковых микроигл, покрытых антигеном, для внутрикож-ной доставки ИПВ.…”