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F. M. Kibengo, Ruzagira, E., Katende, D., Bwanika, A. N., Bahemuka, U., Kamali, A., Haberer, J. E., Bangsberg, D. R., Barin, B., Rooney, J. F., Mark, D., Chetty, P., Fast, P., and Priddy, F. H., Safety, Adherence and Acceptability of Intermittent Tenofovir/Emtricitabine as HIV Pre-exposure Prophylaxis (PrEP) among HIV-Uninfected Ugandan Volunteers Living in HIV-Serodiscordant Relationships: A Randomized, Clinical Trial, PLoS One, vol. 8, p. e74314, 2013.
G. Mutua, Sanders, E., Mugo, P., Anzala, O., Haberer, J. E., Bangsberg, D., Barin, B., Rooney, J. F., Mark, D., Chetty, P., Fast, P., and Priddy, F. H., Safety and Adherence to Intermittent Pre-Exposure Prophylaxis (PrEP) for HIV-1 in African Men Who Have Sex with Men and Female Sex Workers, PLoS One, vol. 7, p. e33103, 2012.
M. Cohen-Wolkowiez, Poindexter, B., Bidegain, M., Weitkamp, J. - H., Schelonka, R. L., Randolph, D. A., Ward, R. M., Wade, K., Valencia, G., Burchfield, D., Arrieta, A., Mehta, V., Walsh, M., Kantak, A., Rasmussen, M., Sullivan, J. E., Finer, N., Rich, W., Brozanski, B. S., van den Anker, J., Blumer, J., Laughon, M., Watt, K. M., Kearns, G. L., Capparelli, E. V., Martz, K., Berezny, K., Benjamin, D. K., and P Smith, B., Safety and Effectiveness of Meropenem in Infants with Suspected or Complicated Intra-Abdominal Infections, Clin Infect Dis, vol. 55, no. 11, pp. 1495-1502, 2012.
B. Rivoire, Groathouse, N., TerLouw, S., K Neupane, D., Ranjit, C., B Sapkota, R., Khadge, S., Kunwar, C., Macdonald, M., Hawksworth, R., Thapa, M., Hagge, D., Tibbals, M., Smith, C., Dube, T., She, D., Wolff, M., ,, Sizemore, C., and Brennan, P., Safety and Efficacy Assessment of Two New Leprosy Skin Test Antigens: Randomized Double Blind Clinical Study, PLOS Neglected Tropical Diseases, vol. 8, p. e2811, 2014.
W. Harmon, Meyers, K., Ingelfinger, J., McDonald, R., McIntosh, M., Ho, M., Spaneas, L., Palmer, J., Hawk, M., Geehan, C., Tinckam, K., Hancock, W., and Sayegh, M., Safety and Efficacy of a Calcineurin-Inhibitor Avoidance Regimen in Pediatric Renal Transplantation, J Am Soc Nephrol, vol. 17, pp. 1735-1745, 2006.
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, 2018.
D. J. S. Thompson, Barron, K., Whitcup, S., and Robinson, M., The safety and efficacy of chicken type II collagen on uveitis associated with juvenile rheumatoid arthritis, Ocular Immunology & Inflammation, vol. 10, pp. 83-91, 2002.
S. E. Frey, Bernstein, D. I., Gerber, M. A., Keyserling, H. L., Munoz, F. M., Winokur, P. L., Turley, C. B., Rupp, R. E., Hill, H., Wolff, M., Noah, D. L., Ross, A. C., Cress, G., and Belshe, R. B., Safety and Immune Responses in Children After Concurrent or Sequential 2009 H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations, J Infect Dis, vol. 206, pp. 828-837, 2012.
R. B. Belshe, Stevens, C., Gorse, G. J., Buchbinder, S., Weinhold, K., Sheppard, H., Stablein, D., Self, S., McNamara, J., Frey, S., Flores, J., Excler, J. L., Klein, M., Habib, R. E., Duliege, A. M., Harro, C., Corey, L., Keefer, M., Mulligan, M., Wright, P., Celum, C., Judson, F., and , Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus Type 1 vaccine with or without gp120: a phase 2 study in higher- and lower-risk volunteers, J Infec Dis, vol. 183, pp. 1343-52, 2001.
B. S. Graham, Keefer, M. C., McElrath, M. J., Gorse, G. J., Schwartz, D. H., Weinhold, K., Matthews, T. J., ,, Sinangil, F., and Fast, P. E., Safety and Immunogenicity of a Candidate HIV-1 Vaccine in Healthy Adults: Recombinant Glycoprotein (rgp) 120. A Randomized, Double-Blind Trial, Ann Intern Med, vol. 125, no. 4, pp. 270-279, 1996.
L. A. Jackson, Frey, S. E., Sahly, H. M. El, Mulligan, M. J., Winokur, P. L., Kotloff, K. L., Campbell, J. D., Atmar, R. L., Graham, I., Anderson, E. J., Anderson, E. L., Patel, S. M., Fields, C., Keitel, W., Rouphael, N., Hill, H., and Goll, J. B., Safety and Immunogenicity of a Modified Vaccinia Ankara Vaccine Using Three Immunization Schedules and Two Modes of Delivery: A Randomized Clinical Non-Inferiority Trial, Vaccine, vol. 35, no. 13, pp. 1675-1682, 2017.
M. J. Groome, Koen, A., Fix, A., Page, N., Jose, L., Madhi, S. A., McNeal, M., Dally, L., Cho, I., Power, M., Flores, J., and Cryz, S., Safety and Immunogenicity of a Parenteral P2-VP8-P[8] Subunit Rotavirus Vaccine in Toddlers and Infants in South Africa: A Randomised, Double-Blind, Placebo-Controlled Trial, Lancet Infect Dis, vol. 17, no. 8, pp. 843-853, 2017.
A. D. Fix, Harro, C., McNeal, M., Dally, L., Flores, J., Robertson, G., Boslego, J. W., and Cryz, S., Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults., Vaccine, vol. 33, no. 31, pp. 3766-3772, 2015.
W. H. Chen, Pasetti, M. F., Adhikari, R. P., Baughman, H., Douglas, R., El-Khorazaty, J., Greenberg, N., Holtsberg, F. W., Liao, G. C., Reymann, M. K., Wang, X., Warfield, K. L., and Aman, M. J., Safety and Immunogenicity of a Parenterally Administered, Structure-Based Rationally Modified Recombinant Staphylococcal Enterotoxin B Protein Vaccine, STEBVax, Clin Vaccine Immunol, vol. 23, no. 12, pp. 918-925, 2016.
J. J. Treanor, Wilkinson, B. E., Masseoud, F., Hu-Primmer, J., Battaglia, R., O’Brien, D., Wolff, M., Rabinovich, G., Blackwelder, W., and Katz, J. M., Safety and Immunogenicity of a Recombinant Hemagglutinin Vaccine for H5 Influenza in Humans, Vaccine, vol. 19, pp. 1732-1737, 2001.
J. J. Treanor, Wilkinson, B. E., Masseoud, F., Hu-Primmer, J., Battaglia, R., O’Brien, D., Wolff, M., Rabinovich, G., Blackwelder, W., and Katz, J. M., Safety and Immunogenicity of a Recombinant Hemagglutinin Vaccine for H5 Influenza in Humans, 1999.
E. H Sahly, Patel, S., Atmar, R., Lanford, T., Dube, T., Thompson, D., Sim, B. K., Long, C., and Keitel, W., Safety and Immunogenicity of a Recombinant Nonglycosylated Erythrocyte Binding Antigen 175 Region II Malaria Vaccine in Healthy Adults Living in an Area Where Malaria is Not Endemic, Clinical and Vaccine Immunology, vol. 17, pp. 1552-1559, 2010.
P. L. Winokur, Patel, S. M., Brady, R., Chen, W. H., El-Kamary, S. S., Edwards, K., Creech, C. B., Frey, S., Keitel, W. A., Belshe, R., Walter, E., Bellamy, A., and Hill, H., Safety and Immunogenicity of a Single Low Dose or High Dose of Clade 2 Influenza A(H5N1) Inactivated Vaccine in Adults Previously Primed With Clade 1 Influenza A(H5N1) Vaccine, J Infect Dis, vol. 212, no. 4, pp. 525-530, 2015.
R. C. Brady, Treanor, J. J., Atmar, R. L., Keitel, W. A., Edelman, R., Chen, W. H., Winokur, P., Belshe, R., Graham, I. L., Noah, D. L., Guo, K., and Hill, H., Safety and Immunogenicity of a Subvirion Inactivated Influenza a/H5N1 Vaccine With or Without Aluminum Hydroxide Among Healthy Elderly Adults, Vaccine, vol. 27, pp. 5091-5095, 2009.
W. A. Keitel, Jackson, L. A., Edupuganti, S., Winokur, P. L., Mulligan, M. J., Thornburg, N. J., Patel, S. M., Rouphael, N. G., Lai, L., Bangaru, S., McNeal, M. M., Bellamy, A. R., and Hill, H. R., Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons >/=18 Years Old, J Infect Dis, vol. 212, no. 4, pp. 552-561, 2015.
M. Thera, Doumbo, O., Coulibaly, D., Laurens, M., Kone, A., Guindo, A., Traore, K., Sissoko, M., Diallo, D., Diarra, I., Kouriba, B., Daou, M., Dolo, A., Baby, M., Sissoko, M., Sagara, I., Niangaly, A., Traore, I., Olotu, A., Godeaux, O., Leach, A., Dubois, M., and Ballou, W., Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian Children: Results of a Phase 1 Randomized Controlled Trial, PLoS One, vol. 5, p. e9041, 2010.
W. A. Keitel, Campbell, J. D., Treanor, J. J., Walter, E. B., Patel, S. M., He, F., Noah, D. L., and Hill, H., Safety and Immunogenicity of an Inactivated Influenza A/H5N1 Vaccine Given Without or With Aluminum Hydroxide to Healthy Adults: Results of a Phase I-II Randomized Clinical Trial, J Infec Dis, vol. 198, pp. 1309-1316, 2009.
J. J. Treanor, Campbell, J., Zangwill, K. M., Rowe, T., and Wolff, M. C., Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine, N Engl J Med, vol. 354, pp. 1343-1351, 2006.
U. Sarwar, Costner, P., Enama, M., Berkowitz, N., Hu, Z., Hendel, C., Sitar, S., Plummer, S., Mulangu, S., Bailer, R., Koup, R., Mascola, J., Nabel, G., Sullivan, N., Graham, B., and Ledgerwood, J. E., Safety and Immunogenicity of DNA Vaccines Encoding Ebolavirus and Marburgvirus Wild-Type Glycoproteins in a Phase I Clinical Trial, J Infect Dis, vol. 211, no. 4, pp. 549-557, 2015.
H. Kibuuka, Berkowitz, N., Millard, M., Enama, M., Tindikahwa, A., Sekiziyivu, A., Costner, P., Sitar, S., Glover, D., Hu, Z., Joshi, G., Stanley, D., Kunchai, M., Eller, L., Bailer, R., Koup, R., Nabel, G., ,, Robb, M., and Ledgerwood, J., Safety and Immunogenicity of Ebola Virus and Marburg Virus Glycoprotein DNA Vaccines Assessed Separately and Concomitantly in Healthy Ugandan Adults: A Phase 1b, Randomised, Double-Blind, Placebo-Controlled Clinical Trial, Lancet, vol. 385, no. 9977, pp. 1545-1554, 2015.