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1. Assessing the risk of a clinically significant infection from a Microneedle Array Patch (MAP) product

Author

Dul, Maria, Alali, Mohammed, Ameri, Mahmoud, Burke, Matthew Douglas, Craig, Christine M., Creelman, Benjamin Paul, Dick, Lisa, Donnelly, Ryan F., Eakins, Michael N., Frivold, Collrane, Forster, Angus Harry, Gilbert, Philippe-Alexandre, Henke, Stefan, Henry, Sebastien, Hunt, Desmond, Lewis, Hayley, Maibach, Howard I., Mistilis, Jessica Joyce, Park, Jung-Hwan, Prausnitz, Mark R., Robinson, David Kenneth, Hernandez, Carmen Amelia Rodriguez, Ross, Charles, Shin, Juyeop, Speaker, Tycho Joseph, Taylor, Kevin Michael, Zehrung, Darin, Birchall, James C., Jarrahian, Courtney, and Coulman, Sion A.

Published
2023
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2. Contributors

Author

Abzug, Mark J., primary, Acharya, Priyamvada, additional, Acosta, Anna M., additional, Ahmed, S. Sohail, additional, Amanna, Ian J., additional, Anderson, Annaliesa S., additional, Asturias, Edwin J., additional, Bachmann, Martin F., additional, Bahl, Sunil, additional, Bailey, Justin R., additional, Baker, Carol J., additional, Balfour, Henry H., additional, Baric, Ralph S., additional, Barnett, Elizabeth D., additional, Barrett, Alan D.T., additional, Belser, Jessica A., additional, Berzofsky, Jay A., additional, Bethony, Jeffrey M., additional, Brewer-Jensen, Paul D., additional, Bubak, Andrew N., additional, Burns, Cara C., additional, Caplan, Arthur L., additional, Cavaleri, Marco, additional, Chandran, Aruna, additional, Cherian, Thomas, additional, Clemens, John D., additional, Cochino, Emil, additional, Cohet, Catherine, additional, Cohn, Amanda, additional, Cortese, Margaret M., additional, Crowcroft, Natasha S., additional, Curtis, Nigel, additional, Damron, F. Heath, additional, Danchin, Margie, additional, Debbink, Kari, additional, Desai, Sachin N., additional, Davis, Emily H., additional, Decker, Michael D., additional, Denison, Mark R., additional, DeStefano, Frank, additional, Douglas, R. Gordon, additional, Dreher-Lesnick, Sheila M., additional, Eberhardt, Christiane S., additional, Edmunds, W. John, additional, Edwards, Caitlin E., additional, Edwards, Kathryn M., additional, Eggers, Rudolf, additional, Ellis, Ronald, additional, Erdman, Dean D., additional, Ertl, Hildegund C.J., additional, Estivariz, Concepcion F., additional, Fine, Paul E.M., additional, Finn, Theresa M., additional, Fisher, Allison M., additional, Fitzwater, Sean Patrick, additional, Freedman, Mark S., additional, Friede, Martin, additional, Friedlander, Arthur M., additional, Frumento, Nicole, additional, Fry, Alicia M., additional, Garçon, Nathalie, additional, Geris, Jennifer M., additional, Gershon, Anne A., additional, Gervier, Regis, additional, Gessner, Bradford D., additional, Gilbert, Peter B., additional, Gomez, Phillip Louis, additional, Ginsberg, Ann M., additional, Grabenstein, John D., additional, Graham, Rachel L., additional, Graham, Barney S., additional, Granoff, Dan M., additional, Gray, Gregory C., additional, Greenberg, David P., additional, Grohskopf, Lisa A., additional, Gruber, Marion F., additional, Guerena, Fernando B., additional, Havelange, Nicolas, additional, Halstead, Scott B., additional, Hanekom, Willem A., additional, Harrison, Lee H., additional, Hawn, Thomas R., additional, Haynes, Barton F., additional, Healy, C. Mary, additional, Hills, Susan L., additional, Hirabayashi, Kuniko, additional, Holmgren, Jan, additional, Hombach, Joachim M., additional, Hotez, Peter Jay, additional, Howe, Barbara J., additional, Hunegnaw, Ruth, additional, Izopet, Jacques, additional, Jamieson, Denise J., additional, Jansen, Kathrin, additional, Jarrahian, Courtney, additional, Johansen, Kari, additional, Kahn, Geoffrey D., additional, Karron, Ruth A., additional, Katz, Jacqueline M., additional, Kennedy, Richard B., additional, Broojerdi, Alireza Khadem, additional, Khetsuriani, Nino, additional, Khudyakov, Yury, additional, Klugman, Keith P., additional, Kocher, Jacob F., additional, Kollaritsch, Herwig, additional, Kotloff, Karen L., additional, Kozarsky, Phyllis E., additional, Kreimer, Aimée R., additional, Kroger, Andrew T., additional, Kwong, Peter D., additional, Lal, Manjari, additional, Levin, Myron J., additional, Levine, Myron M., additional, Lindesmith, Lisa C., additional, Lindstrand, Ann, additional, Ljungman, Per, additional, Lowy, Douglas R., additional, Lundgren, Anna, additional, Lydon, Patrick, additional, Macklin, Grace R., additional, Maeng, Hoyoung M., additional, Mahalingam, Ravi, additional, Malley, Richard, additional, Mallory, Michael L., additional, Marfin, Anthony A., additional, Markowitz, Lauri E., additional, Marshall, CDR Valerie, additional, McCollum, Andrea, additional, Meyer, Sarah, additional, McNamara, Lucy A., additional, Menning, Lisa, additional, Messacar, Kevin, additional, Miller, Mark A., additional, Milutinovic, Pavle, additional, Modlin, John F., additional, Monath, Thomas P., additional, Morabito, Kaitlyn M., additional, Moss, William J., additional, Mulholland, Kim, additional, Mura, Manuela, additional, Musher, Daniel M., additional, Nagel, Maria A., additional, Nair, G. Balakrish, additional, Nelson, Noele P., additional, Netea, Mihai G., additional, Neuzil, Kathleen Maletic, additional, Niemeyer, Christy S., additional, Nohynek, Hanna, additional, Norheim, Gunnstein, additional, Nussbaum, Lauren, additional, O’Brien, Katherine L., additional, O’Leary, Sean, additional, Ockenhouse, Christian, additional, Offit, Paul A., additional, Okwo-Bele, Jean-Marie, additional, Olkhanud, Purevdorj B., additional, Omer, Saad B., additional, Orenstein, Walter A., additional, Oyston, Petra C.F., additional, Parashar, Umesh D., additional, Patel, Manish M., additional, Payne, Daniel C., additional, Pebody, Richard, additional, Pecetta, Simone, additional, Perlman, Stanley, additional, Pierson, Benjamin, additional, Pierson, Theodore C., additional, Pittet, Laure F., additional, Pittman, Phillip R., additional, Plotkin, Stanley A., additional, Plotkin, Susan L., additional, Poland, Gregory A., additional, Pollard, Sir Andrew John, additional, Poovorawan, Yong, additional, Proctor, Richard A., additional, Qadri, Firdausi, additional, Rao, Agam, additional, Rappuoli, Rino, additional, Reef, Susan E., additional, Rogalewicz, Joseph A., additional, Robinson, James Michael, additional, Roesel, Sigrun, additional, Rubin, Steven A., additional, Rupprecht, Charles E., additional, Rutter, Paul, additional, Samant, Vijay B., additional, Sambhara, Suryaprakash, additional, Samies, Nicole L., additional, Santosham, Mathuram, additional, Saunders, Kevin O., additional, Schiller, John T., additional, Schleiss, Mark R., additional, Schuerman, Lode, additional, Schwab, Jennifer, additional, Schwartz, Jason L., additional, Scobie, Heather M., additional, Scott, J. Anthony, additional, Shapiro, Eugene D., additional, Shenoy, Erica S., additional, Shimabukuro, Tom T., additional, Shouval, Daniel, additional, Siegrist, Claire-Anne, additional, Sitrin, Robert D., additional, Skinner, Nicole E., additional, Slifka, Mark K., additional, Sodha, Samir V., additional, Soeters, Heidi M., additional, Solomon, Tom, additional, Speiser, Daniel E., additional, Staples, J. Erin, additional, Steffen, Robert, additional, Stephens, David S., additional, Strebel, Peter M., additional, Subbarao, Kanta, additional, Sullivan, Nancy J., additional, Takashima, Yoshihiro, additional, Tate, Jacqueline E., additional, Tayman, Alice, additional, Telford, Sam R., additional, Thombley, Melisa, additional, Thomsen, Isaac, additional, Tohme, Rania A., additional, Trabold, Malin, additional, El-Turabi, Aadil, additional, Vaughn, David W., additional, Verardi, Raffaello, additional, Vicari, Andrea S., additional, Vidor, Emmanuel J., additional, Villafana, Tonya, additional, Vogt, Matthew R., additional, Walker, Mark J., additional, Walsh, Nick M., additional, Wanlapakorn, Nasamon, additional, Ward, John W., additional, Wassilak, Steven G.F., additional, Watts, Lisa A., additional, Weber, David J., additional, Weiner, David B., additional, Weng, Mark K., additional, Wexler, Deborah L., additional, Wharton, Melinda, additional, Whitley, Richard J., additional, Whitney, Cynthia G., additional, Wiehe, Kevin, additional, Williamson, E. Diane, additional, Wormser, Gary P., additional, Xia, Ningshao, additional, Yildirim, Inci, additional, Zehrung, Darin, additional, and Zweigart, Mark R., additional

Published
2023
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8. Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial

Author

Ramaganeshan, D., Sapru, Amita, Pandit, Anand, Kawade, Anand, Lalwani, Sanjay, Palkar, Sonali, Hanumante, Nita, Malshe, Nandini, Krishna, Vidya, Ingale, S.Y., Gunale, Bhagwat, Chaudhari, Amol, Saganic, Laura, Jarrahian, Courtney, Bavdekar, Ashish, Oswal, Jitendra, Ramanan, Padmasani Venkat, Aundhkar, Chandrashekhar, Venugopal, P., Kapse, Dhananjay, Miller, Tara, McGray, Sarah, Zehrung, Darin, and Kulkarni, Prasad S.

Published
2018
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9. Fractional-dose inactivated poliovirus vaccine, India/Inde--Vaccin antipoliomyelitique inactive en doses fractionnees/Vacuna inactivada del poliovirus de dosis fraccionada, India

Author

Haldar, Pradeep, Agrawal, Pankaj, Bhatnagar, Pankaj, Tandon, Rajiv, McGray, Sarah, Zehrung, Darin, Jarrahian, Courtney, and Foster, Jennifer

Subjects
Public health -- Analysis, Poliovirus vaccines -- Supply and demand -- Dosage and administration, Company business planning, Health, World Health Organization -- Planning
Abstract

In 2016, the World Health Organization (WHO) announced a global shortage of inactivated poliovirus vaccine that was expected to last until 2020 at least. In response, WHO's Strategic Advisory Group of Experts on Immunization recommended that countries consider a strategic shift to fractional-dose inactivated poliovirus vaccine, which involves a new dosing schedule (i.e. administered at 6 and 14 weeks of age) and has a different mode of delivery than full-dose inactivated poliovirus vaccine (i.e. intradermal rather than intramuscular). Introduction of fractional-dosing requires careful planning and management to ensure adequate vaccine supplies, to prevent wastage, to provide training for health workers, and to ensure accurate record-keeping. In early 2016, given the global vaccine shortage and a limited supply from domestic manufacturers, India's Expert Advisory Group on polio recommended the staggered introduction of fractional-dosing. India was the first country to introduce fractional-dose inactivated poliovirus vaccine into routine immunization, initially in eight states in 2016. Following a rapid assessment of its initial implementation, fractional-dosing was extended and, by June 2017, all Indian states were covered. Here we summarize India's experience with the introduction, discuss the challenges faced and the strategies used to address them, and report on the outcomes achieved. We also describe the lessons learnt, especially managing vaccine supplies and wastage, monitoring and supervision, and training needs. As the use of fractional-dose inactivated poliovirus vaccine is dose-sparing and reduces the cost of the immunization programme, it will remain an important part of India's long-term strategy for polio vaccination. [phrase omitted] En 2016, l'Organisation mondiale de la Sante (OMS) a annonce une penurie mondiale du vaccin antipoliomyelitique inactive, prevue pour durer jusqu'a 2020 au minimum. Face a cette situation, le Groupe strategique consultatif d'experts sur la vaccination a recommande aux pays d'envisager un changement de strategie afin de privilegier l'utilisation du vaccin antipoliomyelitique inactive en doses fractionnees, ce qui implique un nouveau calendrier de vaccination (administration du vaccin a l'age de 6 et de 14 semaines) et un mode d'administration different de celui du vaccin antipoliomyelitique inactive en dose complete (par voie intradermique et non pas par voie intramusculaire). L'introduction d'une vaccination en doses fractionnees exige de la rigueur en matiere de planification et de gestion, afin de garantir des stocks de vaccins suffisants, d'eviter les gaspillages, de former les agents de sante et d'assurer une tenue precise des dossiers medicaux. Debut 2016, du fait de la penurie mondiale du vaccin et d'un approvisionnement limite par les fabricants nationaux, le Groupe consultatif d'experts de l'Inde sur l'eradication de la poliomyelite a recommande d'introduire progressivement les doses fractionnees. Si bien que l'Inde est le premier pays a avoir introduit le vaccin antipoliomyelitique inactive en doses fractionnees dans le calendrier de vaccination systematique, d'abord dans huit Etats en 2016. Apres une rapide evaluation de cette mise en oeuvre initiale, l'utilisation des doses fractionnees s'est etendue, pour finalement etre effective dans tous les Etats indiens en juin 2017. Dans cet article, nous recapitulons l'experience de l'Inde a ce sujet, nous evoquons les defis rencontres et les strategies employees pour les surmonter ainsi que les resultats obtenus. Nous decrivons egalement les enseignements tires de cette experience, notamment en matiere de gestion des stocks de vaccins, de prevention des gaspillages, de suivi et de supervision, mais aussi concernant les besoins en formation. Etant donne que l'utilisation de doses fractionnees du vaccin antipoliomyelitique inactive permet d'economiser des doses vaccinales et de reduire le cout du programme de vaccination, cela restera un element essentiel dans la strategie a long terme de l'Inde en matiere de vaccination contre la poliomyelite. [phrase omitted] En 2016, la Organizacion Mundial de la Salud (OMS) anuncio una escasez mundial de vacunas inactivadas del poliovirus que se esperaba que se prolongara al menos hasta 2020. En respuesta, el Grupo de asesoramiento estrategico de expertos en inmunizacion de la OMS recomendo que los paises consideraran la posibilidad de un cambio estrategico hacia una vacuna inactivada del poliovirus de dosis fraccionada, que incluye un nuevo esquema de dosificacion (es decir, administrada a las seis y a las catorce semanas de edad) y que tiene un modo de administracion diferente al de la vacuna inactivada del poliovirus de dosis completa (es decir, intradermica y no intramuscular). La introduccion de la dosis fraccionada requiere una planificacion y una gestion minuciosas para garantizar el suministro adecuado de las vacunas, evitar el despilfarro, formar a los trabajadores sanitarios y garantizar el mantenimiento de registros precisos. A principios de 2016, dada la escasez mundial de vacunas y el limitado suministro de los fabricantes nacionales, el Grupo de asesoramiento experto sobre la polio de la India recomendo la introduccion escalonada de dosis fraccionadas. La India fue el primer pais en introducir la vacuna inactivada del poliovirus de dosis fraccionada en la inmunizacion sistematica, inicialmente en ocho estados en 2016. Tras una rapida evaluacion de la aplicacion inicial, se amplio la dosificacion fraccionada y, para junio de 2017, se cubrieron todos los estados de la India. En este documento se resume la experiencia de la India con la introduccion, se examinan los problemas encontrados y las estrategias utilizadas para resolverlos y se informa sobre los resultados alcanzados. Tambien se describen las lecciones aprendidas, especialmente en lo que se refiere a la gestion de los suministros de vacunas y el desperdicio, el seguimiento y la supervision, y las necesidades de formacion. Dado que el uso de la vacuna inactivada del poliovirus de dosis fraccionada ahorra dosis y reduce el coste del programa de inmunizacion, seguira siendo una parte importante de la estrategia a largo plazo de la India para la vacunacion contra la polio., Introduction In early 2016, the World Health Organization (WHO) announced a global shortage of inactivated poliovirus vaccine, (1,2) which was estimated in 2017 to last until 2020 and potentially beyond. [...]

Published
2019
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21. A randomized clinical trial in adults and newborns in South Africa to compare the safety and immunogenicity of bacille Calmette-Guérin (BCG) vaccine administration via a disposable-syringe jet injector to conventional technique with needle and syringe

Author

Geldenhuys, Hennie D., Mearns, Helen, Foster, Jennifer, Saxon, Eugene, Kagina, Benjamin, Saganic, Laura, Jarrahian, Courtney, Tameris, Michele D., Dintwe, One B., Van Rooyen, Michele, Luabeya, Kany-Kany A., Hussey, Gregory, Scriba, Thomas J., Hatherill, Mark, and Zehrung, Darin

Published
2015
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22. Contributors

Author

Abrignani, Sergio, primary, Ahmed, S. Sohail, additional, Amanna, Ian J., additional, Anderson, Teresa A., additional, Arlett, Peter R., additional, Atkinson, William L., additional, Averhoff, Francisco M., additional, Aylward, R. Bruce, additional, Bachmann, Martin F., additional, Baker, Carol J., additional, Balfour, Henry H., additional, Ballou, W. Ripley, additional, Baric, Ralph S., additional, Barrett, Alan D.T., additional, Barnett, Elizabeth D., additional, Belgharbi, Lahouari, additional, Berinstein, Elliot M., additional, Berinstein, Neil L., additional, Bethony, Jeffrey M., additional, Bogaerts, Hugues, additional, Bot, Adrian, additional, Brachman, Philip S., additional, Bresee, Joseph S., additional, Broojerdi, Alireza Khadem, additional, Caplan, Arthur L., additional, Cavaleri, Marco, additional, Cherian, Thomas, additional, Choi-Sing, Pele, additional, Clemens, John D., additional, Cochi, Stephen L., additional, Cohn, Amanda, additional, Cortese, Capt. Margaret M., additional, Cox, Nancy J., additional, Cutts, Felicity, additional, Dagan, Ron, additional, Dalton, Harry R., additional, Daum, Robert S., additional, Davey, Andrea Sudell, additional, De Francesco, Raffaele, additional, Debbink, Kari, additional, Decker, Michael D., additional, Desai, Sachin N., additional, DeStefano, Frank, additional, Douglas, R. Gordon, additional, Dubischar, Katrin, additional, Edmunds, W. John, additional, Edwards, Kathryn M., additional, Egan, William, additional, Eggers, Rudolf, additional, Ehmann, Falk, additional, Ellis, Ronald W., additional, El-Turabi, Aadil, additional, Erdman, Dean D., additional, Ertl, Hildegund, additional, Fine, Paul E.M., additional, Finn, Theresa M., additional, Fisher, Allison, additional, Friede, Martin, additional, Friedlander, Arthur M., additional, Fry, Alicia M., additional, Garçon, Nathalie, additional, Gastañaduy, Paul A., additional, Gershman, Mark D., additional, Gershon, Anne A., additional, Gessner, Bradford D., additional, Gilbert, Peter, additional, Ginsberg, Ann M., additional, Girard, Marc P., additional, Gomez, Phillip L., additional, Goodson, James L., additional, Goodwin, Robert R., additional, Gordon, Lance K., additional, Grabenstein, John D., additional, Graham, Barney S., additional, Graham, Rachel L., additional, Granoff, Dan M., additional, Gray, Gregory C., additional, Gruber, Marion F., additional, Halstead, Scott B., additional, Hanekom, Willem, additional, Harrison, Lee H., additional, Hawn, Thomas R., additional, Healy, C. Mary, additional, Henderson, Donald A., additional, Hildesheim, Allan, additional, Hills, Susan L., additional, Holmgren, Jan, additional, Hombach, Joachim, additional, Hotez, Peter J., additional, Houghton, Michael, additional, Houston, Avril Melissa, additional, Howe, Barbara J., additional, Izopet, Jacques, additional, Jamieson, Denise J., additional, Jarrahian, Courtney, additional, Johansen, Kari, additional, Karron, Ruth A., additional, Kennedy, Richard B., additional, Kew, Olen M., additional, Khudyakov, Yury, additional, Klein, Michel, additional, Klugman, Keith P., additional, Kocher, Jacob F., additional, Koff, Wayne C., additional, Kollaritsch, Herwig, additional, Kotloff, Karen L., additional, Kozarsky, Phyllis E., additional, Kroger, Andrew T., additional, Kurz, Xavier, additional, Lakdawala, Seema S., additional, Lane, J. Michael, additional, Leigh, Kendra, additional, Levin, Myron J., additional, Levine, Emily Marcus, additional, Levine, Myron M., additional, Lindesmith, Lisa C., additional, Ljungman, Per, additional, Lowy, Douglas R., additional, Luke, Catherine J., additional, Lundgren, Anna, additional, Lydon, Patrick, additional, Malley, Richard, additional, Marin, Mona, additional, Markowitz, Lauri E., additional, Marshall, Lieut. Valerie B., additional, Miller, Mark A., additional, Monath, Thomas P., additional, Moss, William J., additional, Mulholland, Kim, additional, Musher, Daniel M., additional, Nabel, Gary J., additional, Nagarajan, Thirumeni, additional, Nair, GB, additional, Nanduri, Srinivas Acharya, additional, Neddermann, Petra, additional, Nelson, Noele P., additional, Offit, Paul A., additional, Okwo-Bele, Jean-Marie, additional, Omer, Saad B., additional, Orenstein, Walter A., additional, Oyston, Petra C.F., additional, Papania, Mark J., additional, Parashar, Umesh D., additional, Pfeifer, Dina, additional, Pickering, Larry K., additional, Pittman, Phillip R., additional, Ploquin, Aurélie, additional, Plotkin, Stanley A., additional, Plotkin, Susan L., additional, Poland, Gregory A., additional, Pollard, Andrew J., additional, Qadri, Firdausi, additional, Quirk, Mary R., additional, Rao, Raman D.S.V., additional, Rappuoli, Rino, additional, Reef, Susan E., additional, Ridpath, Alison D., additional, Robinson, James M., additional, Rodewald, Lance E., additional, Rodriguez-Hernandez, Carmen A., additional, Roper, Martha H., additional, Rubin, Steven A., additional, Rupprecht, Charles E., additional, Rutala, William A., additional, Salisbury, David, additional, Samant, Vijay B., additional, Sambhara, Suryaprakash, additional, Santosham, Mathuram, additional, Schiller, John T., additional, Schleiss, Mark R., additional, Schuchat, Anne, additional, Schwartz, Jason L., additional, Scobie, Heather M., additional, Scott, J. Anthony, additional, Seward, Jane F., additional, Shouval, Daniel, additional, Siegrist, Claire-Anne, additional, Slifka, Mark K., additional, Sodha, Samir V., additional, Stanberry, Lawrence R., additional, Staples, J. Erin, additional, Steere, Allen C., additional, Steffen, Robert, additional, Strebel, Peter M., additional, Subbarao, Kanta, additional, Sullivan, Nancy J., additional, Sutcliffe, Catherine G., additional, Sutherland, Andrea R., additional, Sutter, Roland W., additional, Thomas, Stephen J., additional, Tiwari, Tejpratap S.P, additional, Tsai, Theodore F., additional, Van Damme, Pierre, additional, Vekemans, Johan, additional, Vidor, Emmanuel, additional, Ward, John W., additional, Wassilak, Steven G.F., additional, Weber, David J., additional, Weiner, David B., additional, Wexler, Deborah L., additional, Wharton, Melinda, additional, Whitney, Cynthia G., additional, Williamson, E. Diane, additional, Wood, David J., additional, Xia, Ningshao, additional, Xu, Zhi Yi, additional, Zanetti, Alessandro, additional, and Zehrung, Darin, additional

Published
2018
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34. Design, Formulation, and Evaluation of Novel Dissolving Microarray Patches Containing Rilpivirine for Intravaginal Delivery

Author

McCrudden, Maeliosa, Larrañeta, Eneko, Clark, Annie, Jarrahian, Courtney, Rein-Weston, Annie, Creelman, Benjamin, Moyo, Yolanda, Lachau-Durand, Sophie, Niemeijer, Nico, Williams, Peter, McCarthy, Helen O., Zehrung, Darin, and Donnelly, Ryan F.

Subjects
SDG 3 - Good Health and Well-being, HIV, microarray patches, pre-exposure prophylaxis, rilpivirine, vaginal delivery
Abstract

Antiretroviral (ARV) drugs have, for many years, been studied and administered in the prevention and treatment of human immunodeficiency virus (HIV). Intramuscular (IM) injection of long acting (LA) ARVs are in clinical development, but injectable formulations require regular access to healthcare facilities and disposal facilities for sharps. The development of a discrete, self-administered, and self-disabling vehicle to deliver ARVs could obviate these issues. This study describes the formulation, mechanical characterization, and in vivo evaluation of dissolving microarray patches (MAPs) containing a LA nanosuspension of the ARV, rilpivirine (RPV, RPV LA), for vaginal delivery. This is the first study to apply MAPs into vaginal tissue. The RPV LA MAPs penetrate ex vivo skin and a synthetic vaginal skin model and withstand the effects of potential dragging motion across synthetic vaginal epithelium. In in vivo studies, the mean plasma concentration of RPV in rats at the 56 day endpoint (116.5 ng mL−1) is comparable to that achieved in the IM control cohort (118.9 ng mL−1). RPV is detected systemically, in lymph and vaginal tissue, indicating the potential to deliver RPV LA to primary sites of viral challenge and replication. This innovative research has future potential for patients and healthcare workers, particularly in low-resource settings.

Published
2019

35. Design, formulation and evaluation of novel dissolving microarray patches containing a long-acting rilpivirine nanosuspension

Author

McCrudden, Maeliosa T. C., Larrañeta, Eneko, Clark, Annie, Jarrahian, Courtney, Rein-Weston, Annie, Lachau-Durand, Sophie, Niemeijer, Nico, Williams, Peter, Haeck, Clement, McCarthy, Helen O., Zehrung, Darin, and Donnelly, Ryan F.

Subjects
SDG 3 - Good Health and Well-being, HIV, Microarray patch, Rilpivirine, Antiretroviral
Abstract

One means of combating the spread of human immunodeficiency virus (HIV) is through the delivery of long-acting, antiretroviral (ARV) drugs for prevention and treatment. The development of a discreet, self-administered and self-disabling delivery vehicle to deliver such ARV drugs could obviate compliance issues with daily oral regimens. Alternatives in development, such as long-acting intramuscular (IM) injections, require regular access to health care facilities and disposal facilities for sharps. Consequently, this proof of concept study was developed to evaluate the use of dissolving microarray patches (MAPs) containing a long-acting (LA) nanosuspension of the candidate ARV drug, rilpivirine (RPV). MAPs were mechanically strong and penetrated skin in vitro, delivering RPV intradermally. In in vivo studies, the mean plasma concentration of RPV in rats (431 ng/ml at the Day 7 time point) was approximately ten-fold greater than the trough concentration observed after a single-dose in previous clinical studies. These results are the first to indicate, by the determination of relative exposures between IM and MAP administration, that larger multi-array dissolving MAPs could potentially be used to effectively deliver human doses of RPV LA. Importantly, RPV was also detected in the lymph nodes, indicating the potential to deliver this ARV agent into one of the primary sites of HIV replication over extended durations. These MAPs could potentially improve patient acceptability and adherence to HIV prevention and treatment regimens and combat instances of needle-stick injury and the transmission of blood-borne diseases, which would have far-reaching benefits, particularly to those in the developing world.

Published
2018

37. Transdermal delivery of vitamin K using dissolving microneedles for the prevention of vitamin K deficiency bleeding

Author

Hutton, Aaron R.J., Quinn, Helen L., McCague, Paul J., Jarrahian, Courtney, Rein-Weston, Annie, Coffey, Patricia S., Gerth-Guyette, Emily, Zehrung, Darin, Larrañeta, Eneko, and Donnelly, Ryan F.

Subjects
Dissolving microneedles (MN), Vitamin K, VKDB, vitamin K deficiency bleeding, Swine, PVP, polyvinylpyrrolidone, Transdermal Patch, LoD, limit of detection, Administration, Cutaneous, Injections, Intramuscular, Article, ICH, International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, vitamin K, LEDC, less economically developed country, Less economically developed countries (LEDCs), Transdermal drug delivery, IM, intramuscular, Animals, Humans, Technology, Pharmaceutical, ComputingMethodologies_COMPUTERGRAPHICS, OCT, optical coherence tomography, RH, relative humidity, Infant, Newborn, FTIR, Fourier Transform Infrared Spectroscopy, Vitamin K Deficiency Bleeding, transdermal drug delivery, Vitamin K deficiency bleeding (VKDB), LoQ, limit of quantification, UV, ultraviolet, less economically developed countries (LEDCs), Drug Liberation, Needles, MN, microneedle, Models, Animal, UK, United Kingdom
Abstract

Graphical abstract, Vitamin K deficiency within neonates can result in vitamin K deficiency bleeding. Ensuring that newborns receive vitamin K is particularly critical in places where access to health care and blood products and transfusions is limited. The World Health Organization recommends that newborns receive a 1 mg intramuscular injection of vitamin K at birth. Evidence from multiple surveillance studies shows that the introduction of vitamin K prophylaxis reduces the incidence of vitamin K deficiency bleeding. Despite these recommendations, coverage of vitamin K prophylactic treatment in low-resource settings is limited. An intramuscular injection is the most common method of vitamin K administration in neonates. In low- and middle-income countries, needle sharing may occur, which may result in the spread of bloodborne diseases. The objective of our study was to investigate the manufacture of microneedles for the delivery of vitamin K. Following microneedle fabrication, we performed insertion studies to assess the microneedle’s mechanical properties. Results indicate that vitamin K in a microneedle array was successfully delivered in vitro across neonatal porcine skin with 1.80 ± 0.08 mg delivered over 24 h. Therefore, this initial study shows that microneedles do have the potential to prevent vitamin K deficiency bleeding. Future work will assess delivery of vitamin K in microneedle array in vivo.

Published
2018

39. Design, Formulation, and Evaluation of Novel Dissolving Microarray Patches Containing Rilpivirine for Intravaginal Delivery

Author

Mc Crudden, Maelíosa T. C., primary, Larrañeta, Eneko, additional, Clark, Annie, additional, Jarrahian, Courtney, additional, Rein‐Weston, Annie, additional, Creelman, Benjamin, additional, Moyo, Yolanda, additional, Lachau‐Durand, Sophie, additional, Niemeijer, Nico, additional, Williams, Peter, additional, McCarthy, Helen O., additional, Zehrung, Darin, additional, and Donnelly, Ryan F., additional

Published
2019
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41. Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial

Author

Bavdekar, Ashish, primary, Oswal, Jitendra, additional, Ramanan, Padmasani Venkat, additional, Aundhkar, Chandrashekhar, additional, Venugopal, P., additional, Kapse, Dhananjay, additional, Miller, Tara, additional, McGray, Sarah, additional, Zehrung, Darin, additional, Kulkarni, Prasad S., additional, Ramaganeshan, D., additional, Sapru, Amita, additional, Pandit, Anand, additional, Kawade, Anand, additional, Lalwani, Sanjay, additional, Palkar, Sonali, additional, Hanumante, Nita, additional, Malshe, Nandini, additional, Krishna, Vidya, additional, Ingale, S.Y., additional, Gunale, Bhagwat, additional, Chaudhari, Amol, additional, Saganic, Laura, additional, and Jarrahian, Courtney, additional

Published
2018
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44. A Genetic Screen for Zygotic Embryonic Lethal Mutations Affecting Cuticular Morphology in the Wasp Nasonia vitripennis

Author

Pultz, Mary Anne, Zimmerman, Kristin K., Alto, Neal M., Kaeberlein, Matt, Lange, Sarah K., Pitt, Jason N., Reeves, Nick L., and Zehrung, Darin L.

Subjects
Wasps -- Genetic aspects, Gene mutations -- Physiological aspects, Developmental biology -- Analysis, Lethal mutation -- Genetic aspects, Biological sciences
Abstract

We have screened for zygotic embryonic lethal mutations affecting cuticular morphology in Nasonia vitripennis (Hymenoptera; Chalcidoidea). Our broad goal was to investigate the use of Nasonia for genetically surveying conservation and change in regulatory gene systems, as a means to understand the diversity of developmental strategies that have arisen during the course of evolution. Specifically, we aim to compare anteroposterior patterning gene functions in two long germ band insects, Nasonia and Drosophila. In Nasonia, unfertilized eggs develop as haploid males while fertilized eggs develop as diploid females, so the entire genome can be screened for recessive zygotic mutations by examining the progeny of [F.sub.1] females. We describe 74 of [is greater than] 100 lines with embryonic cuticular mutant phenotypes, including representatives of coordinate, gap, pair-rule, segment polarity, homeotic, and Polycomb group functions, as well as mutants with novel phenotypes not directly comparable to those of known Drosophila genes. We conclude that Nasonia is a tractable experimental organism for comparative developmental genetic study. The mutants isolated here have begun to outline the extent of conservation and change in the genetic programs controlling embryonic patterning in Nasonia and Drosophila.

Published
2000

48. Immunogenicity and safety of measles–mumps–rubella vaccine delivered by disposable-syringe jet injector in healthy Brazilian infants: A randomized non-inferiority study

Author

de Menezes Martins, Reinaldo, primary, Curran, Birute, additional, Maia, Maria de Lourdes Sousa, additional, Ribeiro, Maria das Graças Tavares, additional, Camacho, Luiz Antonio Bastos, additional, da Silva Freire, Marcos, additional, Yamamura, Anna Maya Yoshida, additional, Siqueira, Marilda Mendonça, additional, Lemos, Maria Cristina F., additional, de Albuquerque, Elizabeth Maciel, additional, von Doellinger, Vanessa dos Reis, additional, Homma, Akira, additional, Saganic, Laura, additional, Jarrahian, Courtney, additional, Royals, Michael, additional, and Zehrung, Darin, additional

Published
2015
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