A Microneedle Patch for Measles and Rubella Vaccination Is Immunogenic and Protective in Infant Rhesus Macaques

Joyce, Jessica C.; Carroll, Timothy D.; Collins, Marcus L.; Chen, Min-hsin; Fritts, Linda; Dutra, Joseph; Rourke, Tracy; Goodson, James L.; McChesney, Michael B.; Prausnitz, Mark R.; Rota, Paul A.

doi:10.1093/infdis/jiy139

Cited by 60 publications

(34 citation statements)

References 49 publications

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“…Similar studies on influenza vaccination have demonstrated comparable or superior responses when compared to responses from conventional intramuscular vaccination (Van Damme et al 2009;Kenney et al 2004). Other studies have demonstrated effective levels of neutralizing antibodies in 100% of measles vaccinated non-human primates compared to 75% of subcutaneously vaccinated non-human primates (Joyce et al 2018). In a phase I, partly blinded controlled trial, authors found no significant statistical difference in antibody titers among groups vaccinated with healthcare-administered intramuscular hypodermic needle influenza vaccine, healthcare-administered MN influenza vaccination patch, and self-administered MN influenzavaccination patch, suggesting a possible future for selfadministered vaccines (Rouphael et al 2017).…”

Section: Introductionmentioning

confidence: 80%

Dermatotoxicology of microneedles (MNs) in man

Cary

Maibach

2019

Biomed Microdevices

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Developed within the last few decades, microneedles (MNs) have only recently seen wide-scale use among the general population, especially in the area of cosmetics. With the FDA only starting to regulate microneedling devices and the many new microneedling products that enter the modern global market, it is of utmost importance to establish the safety profile and reasonable expectations of the microneedling practice and its products. In our review of current literature, the authors searched the keyword Bmicroneedle^with the following terms: Bsafety^, Bside effect^, Btoxicology^, Badverse effect^, Badverse event^, Binfection^, Bdermatitis^, Bgranuloma^, Bscarring^, and Bhyperpigmentation^. Despite wide-scale implementation of MNs, we are likely only beginning to understand the potential of MNs as a medical and consumer product, and we should, therefore, be aware of any potential adverse events associated with the product.

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Section: Introductionmentioning

confidence: 80%

Dermatotoxicology of microneedles (MNs) in man

Cary

Maibach

2019

Biomed Microdevices

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“…Coated and dissolvable MNs represent dry formulations, which compared to liquid‐based injectable vaccines are easier to store, require lesser space and weight capacity for storage, and have reduced cost of transport. Such designs have been developed for viruses including influenza, hepatitis B, hepatitis C, polio, herpes simplex, human papillomavirus, rotavirus, measles and rubella, rabies, HIV, Ebola, chikungunya, and West Nile virus . However despite extensive advances in MN‐based vaccines, there are limited studies addressing the delivery of LAVs.…”

Section: Resultsmentioning

confidence: 99%

“…Only measles and rubella have been successfully adapted for live virus vaccination using MN. Studies involved the intradermal delivery of virus from solid coated or dissolvable MN . With formulation as dissolvable MN vaccine arrays, live measles could be stabilized at 25 °C for months and was demonstrated to induce protective immunity in macaques .…”

Section: Resultsmentioning

confidence: 99%

Microneedle‐based intradermal delivery of stabilized dengue virus

Turvey

Uppu

Sharif

et al. 2019

Bioengineering & Transla Med

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Current live‐attenuated dengue vaccines require strict cold chain storage. Methods to preserve dengue virus (DENV) viability, which enable vaccines to be transported and administered at ambient temperatures, will be decisive towards the implementation of affordable global vaccination schemes with broad immunization coverage in resource‐limited areas. We have developed a microneedle (MN)‐based vaccine platform for the stabilization and intradermal delivery of live DENV from minimally invasive skin patches. Dengue virus‐stabilized microneedle arrays (VSMN) were fabricated using saccharide‐based formulation of virus and could be stored dry at ambient temperature up to 3 weeks with maintained virus viability. Following intradermal vaccination, VSMN‐delivered DENV was shown to elicit strong neutralizing antibody responses and protection from viral challenge, comparable to that of the conventional liquid vaccine administered subcutaneously. This work supports the potential for MN‐based dengue vaccine technology and the progression towards cold chain‐independence. Dengue virus can be stabilized using saccharide‐based formulations and coated on microneedle array vaccine patches for storage in dry state with preserved viability at ambient temperature (VSMN; virus‐stabilized microneedle arrays).

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“…Dissolvable microneedle patches (dMNPs) were fabricated as described previously. 39,40 In this study, the adjuvant-free HBsAg vaccine was mixed into a casting solution at a 60:40 ratio with casting solution containing 25% w/v trehalose and 2.5% w/v CMC in PBS. Failure forces of dMNPs under an axial load were measured utilizing a digital force gauge (MARK-10 Series 5, Copiague, NY).…”

Section: Dissolvable Microneedle Patchesmentioning

confidence: 99%

“…Because infants have weaker immune systems than adults, 50 additional studies will be needed to assess HBsAg vaccination by dMNP in infants, as was done in a recent study of measles and rubella vaccination by dMNP in infant rhesus macaques. 40…”

Section: Immune Response To Adjuvant-free Hbsag Vaccine Delivery Usmentioning

confidence: 99%

Hepatitis B vaccination using a dissolvable microneedle patch is immunogenic in mice and rhesus macaques

Kodani

Choi

et al. 2018

Bioengineering & Transla Med

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Chronic Hepatitis B virus infection remains a major global public health problem, accounting for about 887,000 deaths in 2015. Perinatal and early childhood infections are strongly associated with developing chronic hepatitis B. Adding a birth dose of the hepatitis B vaccine (HepB BD) to routine childhood vaccination can prevent over 85% of these infections. However, HepB BD coverage remains low in many global regions, with shortages of birth attendants trained to vaccinate and limited HepB BD supply at birth. To address the challenges, we developed coated metal microneedle patches (cMNPs) and dissolvable microneedle patches (dMNPs) that deliver adjuvant‐free hepatitis B vaccine to the skin in a simple‐to‐administer manner. The dMNP contains micron‐scale, solid needles encapsulating vaccine antigen and dissolve in the skin, generating no sharps waste. We delivered HepB BD via cMNP to BALB/c mice and via dMNP to both mice and rhesus macaques. Both cMNP and dMNP were immunogenic, generating hepatitis B surface antibody levels similar to human seroprotection. Biomechanical analysis showed that at high forces the microneedles failed mechanically by yielding but microneedles partially blunted by axial compression were still able to penetrate skin. Overall, this study indicates that with further development, dMNPs could offer a method of vaccination to increase HepB BD access and reduce needle waste in developing countries.

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A Microneedle Patch for Measles and Rubella Vaccination Is Immunogenic and Protective in Infant Rhesus Macaques

Abstract: These results show, for the first time, that MR vaccine delivered by MN patch generated protective titers of neutralizing antibodies to both measles and rubella in infant rhesus macaques and afforded complete protection from measles virus challenge.

Cited by 60 publications

References 49 publications

Dermatotoxicology of microneedles (MNs) in man

Dermatotoxicology of microneedles (MNs) in man

Microneedle‐based intradermal delivery of stabilized dengue virus

Hepatitis B vaccination using a dissolvable microneedle patch is immunogenic in mice and rhesus macaques

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