Microneedle patches for hepatitis B vaccination
Lin, Yu An
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Hepatitis B is a liver disease caused by the hepatitis B virus infection. The likelihood of acute hepatitis B to progress to chronic hepatitis B, which significantly increases the risk of developing cirrhosis and hepatocellular carcinoma, is inversely related to the age of infection. At least 50% of the estimated 250 million individuals with chronic hepatitis B worldwide were infected through mother-to-child transmission or during early childhood, especially in areas where hepatitis B is highly endemic. Increased risk of perinatal transmission is associated with high levels of viremia in pregnant women. Thus, the hepatitis B birth dose, administered to infants within 24 hours of birth, is the main modality in the prevention of perinatal transmission and can prevent around 90% of infants infected at birth from becoming chronic carriers. Although the hepatitis B vaccine has been commercially available for almost four decades, and has been proven to be effective and safe with correct storage and administration, hepatitis B remains a serious global health issue. Low and middle-income countries are disproportionately affected by hepatitis B with an estimated 45% of global population residing in an area of high hepatitis B prevalence where most infections are acquired perinatally. Furthermore, chronic hepatitis B infection accounts for around 45% of hepatocellular carcinoma cases, the sixth most common cancer worldwide and third most common cause of cancer-related death in Asia. The low hepatitis B immunization coverage is due to the multiple barriers to effective vaccination in low and middle- income countries. These barriers include the need for trained personnel to administer hypodermic injections, risk of sharps, vaccine refrigeration management, high cost of vaccine/vaccination, need for vaccine reconstitution, and vaccine wastage due to multi- dose vials. To address several vaccination barriers and increase vaccination coverage, transdermal immunization with microneedle patches has been proposed as an alternative to conventional liquid vaccine formulations injected intramuscularly with hypodermic needles. There have been several studies and clinical trials on the use of microneedle patches for influenza vaccination that showed promising results. However, there is currently very limited information regarding the use of microneedle patches specifically for hepatitis B vaccination. Thus, this paper aims to explore the potential use of microneedle patches for hepatitis B vaccination by analyzing the effectiveness, usability, and acceptability of the vaccine. Recent studies have shown that microneedle patches with hepatitis B vaccine not only produced similar immunogenicity to that of a single injected hepatitis B vaccine but was also able to maintain antibody titers for a longer duration. Microneedle patch-based hepatitis B vaccine is also significantly more thermostable than conventional liquid formulations, which could drastically reduce vaccine cost and wastage. Finally, health care workers and vaccine administrators overwhelmingly preferred microneedle patches over hypodermic needles for vaccination. These results support the outstanding potential of microneedle-patch based hepatitis B vaccines to address several challenges with existing vaccines and to increase vaccine coverage, especially in low and middle-income countries with high hepatitis B prevalence.