Emmes Publications

D. I. Bernstein, Pasetti, M. F., Brady, R., Buskirk, A. D., Wahid, R., Dickey, M., Cohen, M., Baughman, H., El-Khorazaty, J., Maier, N., Sztein, M. B., Baqar, S., and A Bourgeois, L., “A Phase 1 dose escalating study of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by sublingual or oral immunization.”, Vaccine, vol. 37, no. 4, pp. 602-611, 2019.

W. A. Keitel, Potter, G. E., Diemert, D., Bethony, J., Sahly, H. M. El, Kennedy, J. K., Patel, S. M., Plieskatt, J. L., Jones, W., Deye, G., Bottazzi, M. E., Hotez, P. J., and Atmar, R. L., “A phase 1 study of the safety, reactogenicity, and immunogenicity of a Schistosoma mansoni vaccine with or without glucopyranosyl lipid A aqueous formulation (GLA-AF) in healthy adults from a non-endemic area.”, Vaccine, vol. 37, no. 43, pp. 6500-6509, 2019.

S. L. Hillier, Ferrieri, P., Edwards, M. S., Ewell, M., Ferris, D., Fine, P., Carey, V., Meyn, L., Hoagland, D., Kasper, D. L., Paoletti, L. C., Hill, H., and Baker, C. J., “A Phase 2, Randomized, Control Trial of Group B Streptococcus (GBS) Type III Capsular Polysaccharide-tetanus Toxoid (GBS III-TT) Vaccine to Prevent Vaginal Colonization With GBS III.”, Clin Infect Dis, vol. 68, no. 12, pp. 2079-2086, 2019.

N. G. Rouphael, Hurwitz, S. J., Hart, M., Beck, A., Anderson, E. J., Deye, G., Osborn, B., Cai, S. Yi, Focht, C., Amegashie, C., Bowlin, T. L., Brooks, J., and Mulligan, M. J., “Phase Ib Trial To Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of Filociclovir (MBX-400, Cyclopropavir) in Healthy Volunteers.”, Antimicrob Agents Chemother, vol. 63, no. 9, 2019.

M. E. Horwitz, Wease, S., Blackwell, B., Valcarcel, D., Frassoni, F., Boelens, J. Jan, Nierkens, S., Jagasia, M., Wagner, J. E., Kuball, J., Koh, L. Piu, Majhail, N. S., Stiff, P. J., Hanna, R., Hwang, W. Y. K., Kurtzberg, J., Cilloni, D., Freedman, L. S., Montesinos, P., and Sanz, G., “Phase I/II Study of Stem-Cell Transplantation Using a Single Cord Blood Unit Expanded Ex Vivo With Nicotinamide.”, J Clin Oncol, vol. 37, no. 5, pp. 367-374, 2019.

E. J. Thompson, Wu, H., Melloni, C., Balevic, S., Sullivan, J. E., Laughon, M., Clark, K. M., Kalra, R., Mendley, S., Payne, E. H., Erinjeri, J., Gelber, C. E., Harper, B., Cohen-Wolkowiez, M., and Hornik, C. P., “Population Pharmacokinetics of Doxycycline in Children.”, Antimicrob Agents Chemother, 2019.

C. P. Hornik, Yogev, R., Mourani, P. M., Watt, K. M., Sullivan, J. E., Atz, A. M., Speicher, D., Al-Uzri, A., Adu-Darko, M., Payne, E. H., Gelber, C. E., Lin, S., Harper, B., Melloni, C., Cohen-Wolkowiez, M., and Gonzalez, D., “Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents.”, J Clin Pharmacol, vol. 59, no. 12, pp. 1606-1619, 2019.

E. A. Oga, Peters, E. N., Mark, K., Trocin, K., and Coleman-Cowger, V. H., “Prenatal Substance Use and Perceptions of Parent and Partner Use Using the 4P's Plus Screener.”, Matern Child Health J, vol. 23, no. 2, pp. 250-257, 2019.

A. Domalpally, Agrón, E., Pak, J. W., Keenan, T. D., Ferris, F. L., Clemons, T. E., and Chew, E. Y., “Prevalence, Risk, and Genetic Association of Reticular Pseudodrusen in Age-related Macular Degeneration: Age-Related Eye Disease Study 2 Report 21.”, Ophthalmology, vol. 126, no. 12, pp. 1659-1666, 2019.

S. R. Donnelly, Hinkle, S. N., Rawal, S., Grunnet, L. G., Chavarro, J. E., Vaag, A., Wu, J., Damm, P., Mills, J. L., Li, M., Bjerregaard, A. A., Thuesen, A. Cathrine B., Gore-Langton, R. E., Francis, E. C., Ley, S. H., Hu, F. B., Tsai, M. Y., Olsen, S. F., and Zhang, C., “Prospective study of gestational diabetes and fatty liver scores 9 to 16 years after pregnancy.”, J Diabetes, vol. 11, no. 11, pp. 895-905, 2019.

S. R. Donnelly, Hinkle, S. N., Rawal, S., Grunnet, L. G., Chavarro, J. E., Vaag, A., Wu, J., Damm, P., Mills, J. L., Li, M., Bjerregaard, A. A., Thuesen, A. Cathrine B., Gore-Langton, R. E., Francis, E. C., Ley, S. H., Hu, F. B., Tsai, M. Y., Olsen, S. F., and Zhang, C., “Prospective Study of Gestational Diabetes and Fatty Liver Scores 9 to 16 Years After Pregnancy”, J Diabetes, vol. 11, no. 11, pp. 895-905, 2019.

H. Tillman, S Johnston, C., Farrant, M., Barsan, W., Elm, J. J., Kim, A. S., Lindblad, A. S., Palesch, Y. Y., and J Easton, D., “Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial.”, JAMA Neurol, vol. 76, no. 7, pp. 774-782, 2019.

S. A. Jongo, Church, L. W. Preston, Mtoro, A. T., Chakravarty, S., Ruben, A. J., Swanson, P. A., Kassim, K. R., Mpina, M., Tumbo, A. - M., Milando, F. A., Qassim, M., Juma, O. A., Bakari, B. M., Simon, B., James, E. R., Abebe, Y., Kc, N., Saverino, E., Gondwe, L., Studer, F., Fink, M., Cosi, G., El-Khorazaty, J., Styers, D., Seder, R. A., Schindler, T., Billingsley, P. F., Daubenberger, C., B Sim, K. Lee, Tanner, M., Richie, T. L., Abdulla, S., and Hoffman, S. L., “Safety and Differential Antibody and T-Cell Responses to the Sporozoite Malaria Vaccine, PfSPZ Vaccine, by Age in Tanzanian Adults, Adolescents, Children, and Infants.”, Am J Trop Med Hyg, vol. 100, no. 6, pp. 1433-1444, 2019.

J. M. Marrazzo, Dombrowski, J. C., Wierzbicki, M. R., Perlowski, C., Pontius, A., Dithmer, D., and Schwebke, J., “Safety and Efficacy of a Novel Vaginal Anti-infective, TOL-463, in the Treatment of Bacterial Vaginosis and Vulvovaginal Candidiasis: A Randomized, Single-blind, Phase 2, Controlled Trial.”, Clin Infect Dis, vol. 68, no. 5, pp. 803-809, 2019.

T. A. Crowell, Colby, D. J., Pinyakorn, S., Sacdalan, C., Pagliuzza, A., Intasan, J., Benjapornpong, K., Tangnaree, K., Chomchey, N., Kroon, E., de Souza, M. S., Tovanabutra, S., Rolland, M., Eller, M. A., Paquin-Proulx, D., Bolton, D. L., Tokarev, A., Thomas, R., Takata, H., Trautmann, L., Krebs, S. J., Modjarrad, K., McDermott, A. B., Bailer, R. T., Doria-Rose, N., Patel, B., Gorelick, R. J., Fullmer, B. A., Schuetz, A., Grandin, P. V., O'Connell, R. J., Ledgerwood, J. E., Graham, B. S., Tressler, R., Mascola, J. R., Chomont, N., Michael, N. L., Robb, M. L., Phanuphak, N., and Ananworanich, J., “Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial.”, Lancet HIV, vol. 6, no. 5, pp. e297-e306, 2019.

H. M. El Sahly, Atmar, R. L., Patel, S. M., Bellamy, A., Liu, L., Hong, W., Zhu, H., Guan, Y., and Keitel, W. A., “Safety and immunogenicity of an 8 year interval heterologous prime-boost influenza A/H7N7-H7N9 vaccination.”, Vaccine, vol. 37, no. 19, pp. 2561-2568, 2019.

K. Modjarrad, Roberts, C. C., Mills, K. T., Castellano, A. R., Paolino, K., Muthumani, K., Reuschel, E. L., Robb, M. L., Racine, T., Oh, M. - D., Lamarre, C., Zaidi, F. I., Boyer, J., Kudchodkar, S. B., Jeong, M., Darden, J. M., Park, Y. K., Scott, P. T., Remigio, C., Parikh, A. P., Wise, M. C., Patel, A., Duperret, E. K., Kim, K. Y., Choi, H., White, S., Bagarazzi, M., May, J. M., Kane, D., Lee, H., Kobinger, G., Michael, N. L., Weiner, D. B., Thomas, S. J., and Maslow, J. N., “Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.”, Lancet Infect Dis, vol. 19, no. 9, pp. 1013-1022, 2019.

C. Carter, Houser, K. V., Yamshchikov, G. V., Bellamy, A. R., May, J., Enama, M. E., Sarwar, U., Larkin, B., Bailer, R. T., Koup, R., Chen, G. L., Patel, S. M., Winokur, P., Belshe, R., Dekker, C. L., Graham, B. S., and Ledgerwood, J. E., “Safety and immunogenicity of investigational seasonal influenza hemagglutinin DNA vaccine followed by trivalent inactivated vaccine administered intradermally or intramuscularly in healthy adults: An open-label randomized phase 1 clinical trial.”, PLoS One, vol. 14, no. 9, p. e0222178, 2019.

F. M. Munoz, Anderson, E. J., Bernstein, D. I., Harrison, C. J., Pahud, B., Anderson, E., C Creech, B., Berry, A. A., Kotloff, K. L., Walter, E. B., Atmar, R. L., Bellamy, A. R., Chang, S., and Keitel, W. A., “Safety and immunogenicity of unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine in children and adolescents.”, Vaccine, vol. 37, no. 36, pp. 5161-5170, 2019.

T. L. Schonfeld, Brown, J. S., N Amoura, J., and Gordon, B. G., “Strength through Structure: Defending a Structured Approach to Contraceptive Mandates in Clinical Research.”, Ethics Hum Res, vol. 41, no. 3, pp. 33-35, 2019.

D. Collie, Gay, K., Sheikh, M., Esterlitz, J., Saver, J., Warach, S., and Janis, Son behalf, “Stroke Version 2.0 Common Data Element (CDE) Review: Updates to the National Institute of Neurological Disorders and Stroke (NINDS) CDEs for Stroke”, in American Academy of Neurology 71st Annual Meeting, Philadelphia, PA, 2019.

M. S. Natrajan, Rouphael, N., Lai, L., Kazmin, D., Jensen, T. L., Weiss, D. S., Ibegbu, C., Sztein, M. B., Hooper, W. F., Hill, H., Anderson, E. J., Johnson, R., Sanz, P., Pulendran, B., Goll, J. B., and Mulligan, M. J., “Systems Vaccinology for a Live Attenuated Tularemia Vaccine Reveals Unique Transcriptional Signatures That Predict Humoral and Cellular Immune Responses.”, Vaccines (Basel), vol. 8, no. 1, 2019.

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