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B
C. Schmidt, Smith, C., Barin, B., Bakhtyari, A., Bart, P. - A., Bekker, L. - G., Chomba, E., Clumeck, N., Ho, D., Hoosen, A., Jaoko, W., Kaleebu, P., Karita, E., Keefer, M. C., van Lunzen, J., McMichael, A., Mehendale, S., Peters, B., Ramanathan, V. D., Robinson, A., Rockstroh, J., Vardas, E., Vets, E., Weber, J., Graham, B. S., Than, S., Excler, J. - L., Kochhar, S., Ho, M., Heald, A., and Fast, P. E., “Background morbidity in HIV vaccine trial participants from various geographic regions as assessed by unsolicited adverse events.”, Hum Vaccin Immunother, vol. 8, no. 5, pp. 630-8, 2012.
C
J. E. Ledgerwood, DeZure, A. D., Stanley, D. A., Coates, E. E., Novik, L., Enama, M. E., Berkowitz, N. M., Hu, Z., Joshi, G., Ploquin, A., Sitar, S., Gordon, I. J., Plummer, S. A., Holman, L. S. A., Hendel, C. S., Yamshchikov, G., Roman, F., Nicosia, A., Colloca, S., Cortese, R., Bailer, R. T., Schwartz, R. M., Roederer, M., Mascola, J. R., Koup, R. A., Sullivan, N. J., and Graham, B. S., “Chimpanzee Adenovirus Vector Ebola Vaccine.”, N Engl J Med, vol. 376, no. 10, pp. 928-938, 2017.
D
J. E. Ledgerwood, Wei, C. - J., Hu, Z., Gordon, I. J., Enama, M. E., Hendel, C. S., McTamney, P. M., Pearce, M. B., Yassine, H. M., Boyington, J. C., Bailer, R., Tumpey, T. M., Koup, R. A., Mascola, J. R., Nabel, G. J., and Graham, B. S., “DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials.”, Lancet Infect Dis, vol. 11, no. 12, pp. 916-24, 2011.
J. E. Ledgerwood, Bellamy, A. R., Belshe, R., Bernstein, D. I., Edupuganti, S., Patel, S. M., Renehan, P., Zajdowicz, T., Schwartz, R., Koup, R., Bailer, R. T., Yamshchikov, G. V., Enama, M. E., Sarwar, U., Larkin, B., and Graham, B. S., “DNA priming for seasonal influenza vaccine: a phase 1b double-blind randomized clinical trial.”, PLoS One, vol. 10, no. 5, p. e0125914, 2015.
B. S. Graham, Enama, M. E., Nason, M. C., Gordon, I. J., Peel, S. A., Ledgerwood, J. E., Plummer, S. A., Mascola, J. R., Bailer, R. T., Roederer, M., Koup, R. A., and Nabel, G. J., “DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.”, PLoS One, vol. 8, no. 4, p. e59340, 2013.
K. V. Houser, Yamshchikov, G. V., Bellamy, A. R., May, J., Enama, M. E., Sarwar, U., Larkin, B., Bailer, R. T., Koup, R., Paskel, M., Subbarao, K., Anderson, E., Bernstein, D. I., Creech, B., Keyserling, H., Spearman, P., Wright, P. F., Graham, B. S., and Ledgerwood, J. E., “DNA vaccine priming for seasonal influenza vaccine in children and adolescents 6 to 17 years of age: A phase 1 randomized clinical trial.”, PLoS One, vol. 13, no. 11, p. e0206837, 2018.
A. Pegu, O'Connell, S. E., Schmidt, S. D., O'Dell, S., Talana, C. A., Lai, L., Albert, J., Anderson, E., Bennett, H., Corbett, K. S., Flach, B., Jackson, L., Leav, B., Ledgerwood, J. E., Luke, C. J., Makowski, M., Nason, M. C., Roberts, P. C., Roederer, M., Rebolledo, P. A., Rostad, C. A., Rouphael, N. G., Shi, W., Wang, L., Widge, A. T., Yang, E. Sung, Beigel, J. H., Graham, B. S., Mascola, J. R., Suthar, M. S., McDermott, A. B., Doria-Rose, N. A., Arega, J., Beigel, J. H., Buchanan, W., Elsafy, M., Hoang, B., Lampley, R., Kolhekar, A., Koo, H., Luke, C., Makhene, M., Nayak, S., Pikaart-Tautges, R., Roberts, P. C., Russell, J., Sindall, E., Albert, J., Kunwar, P., Makowski, M., Anderson, E. J., Bechnak, A., Bower, M., Camacho-Gonzalez, A. F., Collins, M., Drobeniuc, A., Edara, V. Viswanadh, Edupuganti, S., Floyd, K., Gibson, T., Ackerley, C. M. Grimsley, Johnson, B., Kamidani, S., Kao, C., Kelley, C., Lai, L., Macenczak, H., McCullough, M. Paine, Peters, E., Phadke, V. K., Rebolledo, P. A., Rostad, C. A., Rouphael, N., Scherer, E., Sherman, A., Stephens, K., Suthar, M. S., Teherani, M., Traenkner, J., Winston, J., Yildirim, I., Barr, L., Benoit, J., Carste, B., Choe, J., Dunstan, M., Erolin, R., Ffitch, J., Fields, C., Jackson, L. A., Kiniry, E., Lasicka, S., Lee, S., Nguyen, M., Pimienta, S., Suyehira, J., Witte, M., Bennett, H., Altaras, N. Emil, Carfi, A., Hurley, M., Leav, B., Pajon, R., Sun, W., Zaks, T., Coler, R. N., Larsen, S. E., Neuzil, K. M., Lindesmith, L. C., Martinez, D. R., Munt, J., Mallory, M., Edwards, C., Baric, R. S., Berkowitz, N. M., Boritz, E. A., Carlton, K., Corbett, K. S., Costner, P., Creanga, A., Doria-Rose, N. A., Douek, D. C., Flach, B., Gaudinski, M., Gordon, I., Graham, B. S., Holman, L. S., Ledgerwood, J. E., Leung, K., Lin, B. C., Louder, M. K., Mascola, J. R., McDermott, A. B., Morabito, K. M., Novik, L., O'Connell, S., O'Dell, S., Padilla, M., Pegu, A., Schmidt, S. D., Shi, W., Swanson, P. A., Talana, C. A., Wang, L., Widge, A. T., Yang, E. Sung, Zhang, Y., Chappell, J. D., Denison, M. R., Hughes, T., Lu, X., Pruijssers, A. J., Stevens, L. J., Posavad, C. M., Gale, M., Menachery, V., and Shi, P. - Y., “Durability of mRNA-1273 vaccine-induced antibodies against SARS-CoV-2 variants.”, Science, vol. 373, no. 6561, pp. 1372-1377, 2021.
A. Pegu, O'Connell, S. E., Schmidt, S. D., O'Dell, S., Talana, C. A., Lai, L., Albert, J., Anderson, E., Bennett, H., Corbett, K. S., Flach, B., Jackson, L., Leav, B., Ledgerwood, J. E., Luke, C. J., Makowski, M., Nason, M. C., Roberts, P. C., Roederer, M., Rebolledo, P. A., Rostad, C. A., Rouphael, N. G., Shi, W., Wang, L., Widge, A. T., Yang, E. Sung, Beigel, J. H., Graham, B. S., Mascola, J. R., Suthar, M. S., McDermott, A. B., Doria-Rose, N. A., Arega, J., Beigel, J. H., Buchanan, W., Elsafy, M., Hoang, B., Lampley, R., Kolhekar, A., Koo, H., Luke, C., Makhene, M., Nayak, S., Pikaart-Tautges, R., Roberts, P. C., Russell, J., Sindall, E., Albert, J., Kunwar, P., Makowski, M., Anderson, E. J., Bechnak, A., Bower, M., Camacho-Gonzalez, A. F., Collins, M., Drobeniuc, A., Edara, V. Viswanadh, Edupuganti, S., Floyd, K., Gibson, T., Ackerley, C. M. Grimsley, Johnson, B., Kamidani, S., Kao, C., Kelley, C., Lai, L., Macenczak, H., McCullough, M. Paine, Peters, E., Phadke, V. K., Rebolledo, P. A., Rostad, C. A., Rouphael, N., Scherer, E., Sherman, A., Stephens, K., Suthar, M. S., Teherani, M., Traenkner, J., Winston, J., Yildirim, I., Barr, L., Benoit, J., Carste, B., Choe, J., Dunstan, M., Erolin, R., Ffitch, J., Fields, C., Jackson, L. A., Kiniry, E., Lasicka, S., Lee, S., Nguyen, M., Pimienta, S., Suyehira, J., Witte, M., Bennett, H., Altaras, N. Emil, Carfi, A., Hurley, M., Leav, B., Pajon, R., Sun, W., Zaks, T., Coler, R. N., Larsen, S. E., Neuzil, K. M., Lindesmith, L. C., Martinez, D. R., Munt, J., Mallory, M., Edwards, C., Baric, R. S., Berkowitz, N. M., Boritz, E. A., Carlton, K., Corbett, K. S., Costner, P., Creanga, A., Doria-Rose, N. A., Douek, D. C., Flach, B., Gaudinski, M., Gordon, I., Graham, B. S., Holman, L. S., Ledgerwood, J. E., Leung, K., Lin, B. C., Louder, M. K., Mascola, J. R., McDermott, A. B., Morabito, K. M., Novik, L., O'Connell, S., O'Dell, S., Padilla, M., Pegu, A., Schmidt, S. D., Shi, W., Swanson, P. A., Talana, C. A., Wang, L., Widge, A. T., Yang, E. Sung, Zhang, Y., Chappell, J. D., Denison, M. R., Hughes, T., Lu, X., Pruijssers, A. J., Stevens, L. J., Posavad, C. M., Gale, M., Menachery, V., and Shi, P. - Y., “Durability of mRNA-1273 vaccine-induced antibodies against SARS-CoV-2 variants.”, Science, vol. 373, no. 6561, pp. 1372-1377, 2021.
H
U. N. Sarwar, Novik, L., Enama, M. E., Plummer, S. A., Koup, R. A., Nason, M. C., Bailer, R. T., McDermott, A. B., Roederer, M., Mascola, J. R., Ledgerwood, J. E., and Graham, B. S., “Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial.”, PLoS One, vol. 9, no. 9, p. e106240, 2014.
I
B. S. Graham, M McElrath, J., Keefer, M. C., Rybczyk, K., Berger, D., Weinhold, K. J., Ottinger, J., Ferarri, G., Montefiori, D. C., Stablein, D., Smith, C., Ginsberg, R., Eldridge, J., Duerr, A., Fast, P., and Haynes, B. F., “Immunization with cocktail of HIV-derived peptides in montanide ISA-51 is immunogenic, but causes sterile abscesses and unacceptable reactogenicity.”, PLoS One, vol. 5, no. 8, p. e11995, 2010.
M
L. A. Jackson, Anderson, E. J., Rouphael, N. G., Roberts, P. C., Makhene, M., Coler, R. N., McCullough, M. P., Chappell, J. D., Denison, M. R., Stevens, L. J., Pruijssers, A. J., McDermott, A., Flach, B., Doria-Rose, N. A., Corbett, K. S., Morabito, K. M., O'Dell, S., Schmidt, S. D., Swanson, P. A., Padilla, M., Mascola, J. R., Neuzil, K. M., Bennett, H., Sun, W., Peters, E., Makowski, M., Albert, J., Cross, K., Buchanan, W., Pikaart-Tautges, R., Ledgerwood, J. E., Graham, B. S., and Beigel, J. H., “An mRNA Vaccine against SARS-CoV-2 - Preliminary Report.”, N Engl J Med, 2020.
P
A. T. Catanzaro, Koup, R. A., Roederer, M., Bailer, R. T., Enama, M. E., Moodie, Z., Gu, L., Martin, J. E., Novik, L., Chakrabarti, B. K., Butman, B. T., Gall, J. G. D., C King, R., Andrews, C. A., Sheets, R., Gomez, P. L., Mascola, J. R., Nabel, G. J., and Graham, B. S., “Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector.”, J Infect Dis, vol. 194, no. 12, pp. 1638-49, 2006.
B. S. Graham, Koup, R. A., Roederer, M., Bailer, R. T., Enama, M. E., Moodie, Z., Martin, J. E., McCluskey, M. M., Chakrabarti, B. K., Lamoreaux, L., Andrews, C. A., Gomez, P. L., Mascola, J. R., and Nabel, G. J., “Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine.”, J Infect Dis, vol. 194, no. 12, pp. 1650-60, 2006.
M. C. Crank, Gordon, I. J., Yamshchikov, G. V., Sitar, S., Hu, Z., Enama, M. E., Holman, L. S. A., Bailer, R. T., Pearce, M. B., Koup, R. A., Mascola, J. R., Nabel, G. J., Tumpey, T. M., Schwartz, R. M., Graham, B. S., and Ledgerwood, J. E., “Phase 1 study of pandemic H1 DNA vaccine in healthy adults.”, PLoS One, vol. 10, no. 4, p. e0123969, 2015.
A. T. Catanzaro, Roederer, M., Koup, R. A., Bailer, R. T., Enama, M. E., Nason, M. C., Martin, J. E., Rucker, S., Andrews, C. A., Gomez, P. L., Mascola, J. R., Nabel, G. J., and Graham, B. S., “Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine.”, Vaccine, vol. 25, no. 20, pp. 4085-92, 2007.
M. E. Enama, Ledgerwood, J. E., Novik, L., Nason, M. C., Gordon, I. J., Holman, L. S., Bailer, R. T., Roederer, M., Koup, R. A., Mascola, J. R., Nabel, G. J., and Graham, B. S., “Phase I randomized clinical trial of VRC DNA and rAd5 HIV-1 vaccine delivery by intramuscular (i.m.), subcutaneous (s.c.) and intradermal (i.d.) administration (VRC 011).”, PLoS One, vol. 9, no. 3, p. e91366, 2014.
J. E. Ledgerwood, Zephir, K., Hu, Z., Wei, C. - J., Chang, L., Enama, M. E., Hendel, C. S., Sitar, S., Bailer, R. T., Koup, R. A., Mascola, J. R., Nabel, G. J., and Graham, B. S., “Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect.”, J Infect Dis, vol. 208, no. 3, pp. 418-22, 2013.
R. A. Koup, Roederer, M., Lamoreaux, L., Fischer, J., Novik, L., Nason, M. C., Larkin, B. D., Enama, M. E., Ledgerwood, J. E., Bailer, R. T., Mascola, J. R., Nabel, G. J., and Graham, B. S., “Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses.”, PLoS One, vol. 5, no. 2, p. e9015, 2010.
R. A. Seder, Chang, L. - J., Enama, M. E., Zephir, K. L., Sarwar, U. N., Gordon, I. J., Holman, L. S. A., James, E. R., Billingsley, P. F., Gunasekera, A., Richman, A., Chakravarty, S., Manoj, A., Velmurugan, S., Li, M. L., Ruben, A. J., Li, T., Eappen, A. G., Stafford, R. E., Plummer, S. H., Hendel, C. S., Novik, L., Costner, P. J. M., Mendoza, F. H., Saunders, J. G., Nason, M. C., Richardson, J. H., Murphy, J., Davidson, S. A., Richie, T. L., Sedegah, M., Sutamihardja, A., Fahle, G. A., Lyke, K. E., Laurens, M. B., Roederer, M., Tewari, K., Epstein, J. E., B Sim, K. Lee, Ledgerwood, J. E., Graham, B. S., and Hoffman, S. L., “Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine.”, Science, vol. 341, no. 6152, pp. 1359-65, 2013.
S
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.
U. N. Sarwar, Costner, P., Enama, M. E., Berkowitz, N., Hu, Z., Hendel, C. S., Sitar, S., Plummer, S., Mulangu, S., Bailer, R. T., Koup, R. A., Mascola, J. R., Nabel, G. J., Sullivan, N. J., Graham, B. S., 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. 549-57, 2015.
H. Kibuuka, Berkowitz, N. M., Millard, M., Enama, M. E., Tindikahwa, A., Sekiziyivu, A. B., Costner, P., Sitar, S., Glover, D., Hu, Z., Joshi, G., Stanley, D., Kunchai, M., Eller, L. Anne, Bailer, R. T., Koup, R. A., Nabel, G. J., Mascola, J. R., Sullivan, N. J., Graham, B. S., Roederer, M., Michael, N. L., Robb, M. L., and Ledgerwood, J. E., “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. 1545-54, 2015.
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.
E. J. Anderson, Rouphael, N. G., Widge, A. T., Jackson, L. A., Roberts, P. C., Makhene, M., Chappell, J. D., Denison, M. R., Stevens, L. J., Pruijssers, A. J., McDermott, A. B., Flach, B., Lin, B. C., Doria-Rose, N. A., O'Dell, S., Schmidt, S. D., Corbett, K. S., Swanson, P. A., Padilla, M., Neuzil, K. M., Bennett, H., Leav, B., Makowski, M., Albert, J., Cross, K., Edara, V. Viswanadh, Floyd, K., Suthar, M. S., Martinez, D. R., Baric, R., Buchanan, W., Luke, C. J., Phadke, V. K., Rostad, C. A., Ledgerwood, J. E., Graham, B. S., and Beigel, J. H., “Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.”, N Engl J Med, 2020.
W. Jaoko, Karita, E., Kayitenkore, K., Omosa-Manyonyi, G., Allen, S., Than, S., Adams, E. M., Graham, B. S., Koup, R. A., Bailer, R. T., Smith, C., Dally, L., Farah, B., Anzala, O., Muvunyi, C. M., Bizimana, J., Tarragona-Fiol, T., Bergin, P. J., Hayes, P., Ho, M., Loughran, K., Komaroff, W., Stevens, G., Thomson, H., Boaz, M. J., Cox, J. H., Schmidt, C., Gilmour, J., Nabel, G. J., Fast, P., and Bwayo, J., “Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa.”, PLoS One, vol. 5, no. 9, p. e12873, 2010.