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V
A. Spentzou, Bergin, P., Gill, D., Cheeseman, H., Ashraf, A., Kaltsidis, H., Cashin-Cox, M., Anjarwalla, I., Steel, A., Higgs, C., Pozniak, A., Piechocka-Trocha, A., Wong, J., Anzala, O., Karita, E., Dally, L., Gotch, F., Walker, B., Gilmour, J., and Hayes, P., “Viral inhibition assay: a CD8 T cell neutralization assay for use in clinical trials of HIV-1 vaccine candidates.”, J Infect Dis, vol. 201, no. 5, pp. 720-9, 2010.
U
M. D. Tapia, Sow, S. O., Lyke, K. E., Haidara, F. Cheick, Diallo, F., Doumbia, M., Traore, A., Coulibaly, F., Kodio, M., Onwuchekwa, U., Sztein, M. B., Wahid, R., Campbell, J. D., Kieny, M. - P., Moorthy, V., Imoukhuede, E. B., Rampling, T., Roman, F., De Ryck, I., Bellamy, A. R., Dally, L., Mbaya, O. Tshiani, Ploquin, A., Zhou, Y., Stanley, D. A., Bailer, R., Koup, R. A., Roederer, M., Ledgerwood, J., Hill, A. V. S., W Ballou, R., Sullivan, N., Graham, B., and Levine, M. M., “Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-bli”, Lancet Infect Dis, vol. 16, no. 1, pp. 31-42, 2016.
S
B. S. Peters, Jaoko, W., Vardas, E., Panayotakopoulos, G., Fast, P., Schmidt, C., Gilmour, J., Bogoshi, M., Omosa-Manyonyi, G., Dally, L., Klavinskis, L., Farah, B., Tarragona, T., Bart, P. - A., Robinson, A., Pieterse, C., Stevens, W., Thomas, R., Barin, B., McMichael, A. J., McIntyre, J. A., Pantaleo, G., Hanke, T., and Bwayo, J., “Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: effects of dosage and route on safety and immunogenicity.”, Vaccine, vol. 25, no. 11, pp. 2120-7, 2007.
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.
W. Jaoko, Nakwagala, F. N., Anzala, O., Manyonyi, G. Omosa, Birungi, J., Nanvubya, A., Bashir, F., Bhatt, K., Ogutu, H., Wakasiaka, S., Matu, L., Waruingi, W., Odada, J., Oyaro, M., Indangasi, J., Ndinya-Achola, J., Konde, C., Mugisha, E., Fast, P., Schmidt, C., Gilmour, J., Tarragona, T., Smith, C., Barin, B., Dally, L., Johnson, B., Muluubya, A., Nielsen, L., Hayes, P., Boaz, M., Hughes, P., Hanke, T., McMichael, A., Bwayo, J., and Kaleebu, P., “Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa.”, Vaccine, vol. 26, no. 22, pp. 2788-95, 2008.
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. 3766-72, 2015.
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.
P
G. Omosa-Manyonyi, Mpendo, J., Ruzagira, E., Kilembe, W., Chomba, E., Roman, F., Bourguignon, P., Koutsoukos, M., Collard, A., Voss, G., Laufer, D., Stevens, G., Hayes, P., Clark, L., Cormier, E., Dally, L., Barin, B., Ackland, J., Syvertsen, K., Zachariah, D., Anas, K., Sayeed, E., Lombardo, A., Gilmour, J., Cox, J., Fast, P., and Priddy, F., “A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-Uninfected African Adults.”, PLoS One, vol. 10, no. 5, p. e0125954, 2015.
S. Vasan, Schlesinger, S. J., Huang, Y., Hurley, A., Lombardo, A., Chen, Z., Than, S., Adesanya, P., Bunce, C., Boaz, M., Boyle, R., Sayeed, E., Clark, L., Dugin, D., Schmidt, C., Song, Y., Seamons, L., Dally, L., Ho, M., Smith, C., Markowitz, M., Cox, J., Gill, D. K., Gilmour, J., Keefer, M. C., Fast, P., and Ho, D. D., “Phase 1 safety and immunogenicity evaluation of ADVAX, a multigenic, DNA-based clade C/B' HIV-1 candidate vaccine.”, PLoS One, vol. 5, no. 1, p. e8617, 2010.
S. Vasan, Schlesinger, S. J., Chen, Z., Hurley, A., Lombardo, A., Than, S., Adesanya, P., Bunce, C., Boaz, M., Boyle, R., Sayeed, E., Clark, L., Dugin, D., Boente-Carrera, M., Schmidt, C., Fang, Q., Huang, Y., Zaharatos, G. J., Gardiner, D. F., Caskey, M., Seamons, L., Ho, M., Dally, L., Smith, C., Cox, J., Gill, D., Gilmour, J., Keefer, M. C., Fast, P., and Ho, D. D., “Phase 1 safety and immunogenicity evaluation of ADMVA, a multigenic, modified vaccinia Ankara-HIV-1 B'/C candidate vaccine.”, PLoS One, vol. 5, no. 1, p. e8816, 2010.
L
C. Harro, A Bourgeois, L., Sack, D., Walker, R., DeNearing, B., Brubaker, J., Maier, N., Fix, A., Dally, L., Chakraborty, S., Clements, J. D., Saunders, I., and Darsley, M. J., “Live attenuated enterotoxigenic Escherichia coli (ETEC) vaccine with dmLT adjuvant protects human volunteers against virulent experimental ETEC challenge.”, Vaccine, vol. 37, no. 14, pp. 1978-1986, 2019.
I
N. Goonetilleke, Moore, S., Dally, L., Winstone, N., Cebere, I., Mahmoud, A., Pinheiro, S., Gillespie, G., Brown, D., Loach, V., Roberts, J., Guimaraes-Walker, A., Hayes, P., Loughran, K., Smith, C., De Bont, J., Verlinde, C., Vooijs, D., Schmidt, C., Boaz, M., Gilmour, J., Fast, P., Dorrell, L., Hanke, T., and McMichael, A. J., “Induction of multifunctional human immunodeficiency virus type 1 (HIV-1)-specific T cells capable of proliferation in healthy subjects by using a prime-boost regimen of DNA- and modified vaccinia virus Ankara-vectored vaccines expressing HIV-1 Gag coupled”, J Virol, vol. 80, no. 10, pp. 4717-28, 2006.
S. Vasan, Hurley, A., Schlesinger, S. J., Hannaman, D., Gardiner, D. F., Dugin, D. P., Boente-Carrera, M., Vittorino, R., Caskey, M., Andersen, J., Huang, Y., Cox, J. H., Tarragona-Fiol, T., Gill, D. K., Cheeseman, H., Clark, L., Dally, L., Smith, C., Schmidt, C., Park, H. H., Kopycinski, J. T., Gilmour, J., Fast, P., Bernard, R., and Ho, D. D., “In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers.”, PLoS One, vol. 6, no. 5, p. e19252, 2011.
S. Chakraborty, Harro, C., DeNearing, B., Brubaker, J., Connor, S., Maier, N., Dally, L., Flores, J., A Bourgeois, L., Walker, R., and Sack, D. A., “Impact of lower challenge doses of enterotoxigenic Escherichia coli on clinical outcome, intestinal colonization and immune responses in adult volunteers.”, PLoS Negl Trop Dis, vol. 12, no. 4, p. e0006442, 2018.
F
J. Nyombayire, Anzala, O., Gazzard, B., Karita, E., Bergin, P., Hayes, P., Kopycinski, J., Omosa-Manyonyi, G., Jackson, A., Bizimana, J., Farah, B., Sayeed, E., Parks, C. L., Inoue, M., Hironaka, T., Hara, H., Shu, T., Matano, T., Dally, L., Barin, B., Park, H., Gilmour, J., Lombardo, A., Excler, J. - L., Fast, P., Laufer, D. S., and Cox, J. H., “First-in-Human Evaluation of the Safety and Immunogenicity of an Intranasally Administered Replication-Competent Sendai Virus-Vectored HIV Type 1 Gag Vaccine: Induction of Potent T-Cell or Antibody Responses in Prime-Boost Regimens.”, J Infect Dis, vol. 215, no. 1, pp. 95-104, 2017.
E
S. Chakraborty, Harro, C., DeNearing, B., Bream, J., Bauers, N., Dally, L., Flores, J., Van de Verg, L., Sack, D. A., and Walker, R., “Evaluation of the Safety, Tolerability, and Immunogenicity of an Oral, Inactivated Whole-Cell Shigella flexneri 2a Vaccine in Healthy Adult Subjects.”, Clin Vaccine Immunol, vol. 23, no. 4, pp. 315-25, 2016.
D
S. L. Rolsma, Yoder, S. M., Nargi, R. S., Brady, E., Jimenez-Truque, N., Thomsen, I., Kontos, M., Carnahan, R. H., Sutton, R. E., Armstrong, E., Dally, L., Crowe, J. E., Edwards, K. M., and C Creech, B., “Development of a Kinetic ELISA and Reactive B Cell Frequency Assay to Detect Respiratory Syncytial Virus Pre-Fusion F Protein-Specific Immune Responses in Infants”, J Pediatric Infect Dis Soc, vol. 12, no. 5, pp. 298-305, 2023.
C
T. Ford, Wenden, C., Mbekeani, A., Dally, L., Cox, J. H., Morin, M., Winstone, N., Hill, A. V. S., Gilmour, J., and Ewer, K. J., “Cryopreservation-related loss of antigen-specific IFNγ producing CD4 T-cells can skew immunogenicity data in vaccine trials: Lessons from a malaria vaccine trial substudy.”, Vaccine, vol. 35, no. 15, pp. 1898-1906, 2017.
S. Joseph, Quinn, K., Greenwood, A., Cope, A. V., McKay, P. F., Hayes, P. J., Kopycinski, J. T., Gilmour, J., Miller, A. N., Geldmacher, C., Nadai, Y., Ahmed, M. I. M., Montefiori, D. C., Dally, L., Bouliotis, G., Lewis, D. J. M., Tatoud, R., Wagner, R., Esteban, M., Shattock, R. J., McCormack, S., and Weber, J., “A Comparative Phase I Study of Combination, Homologous Subtype-C DNA, MVA, and Env gp140 Protein/Adjuvant HIV Vaccines in Two Immunization Regimes.”, Front Immunol, vol. 8, p. 149, 2017.
E. Karita, Ketter, N., Price, M. A., Kayitenkore, K., Kaleebu, P., Nanvubya, A., Anzala, O., Jaoko, W., Mutua, G., Ruzagira, E., Mulenga, J., Sanders, E. J., Mwangome, M., Allen, S., Bwanika, A., Bahemuka, U., Awuondo, K., Omosa, G., Farah, B., Amornkul, P., Birungi, J., Yates, S., Stoll-Johnson, L., Gilmour, J., Stevens, G., Shutes, E., Manigart, O., Hughes, P., Dally, L., Scott, J., Stevens, W., Fast, P., and Kamali, A., “CLSI-derived hematology and biochemistry reference intervals for healthy adults in eastern and southern Africa.”, PLoS One, vol. 4, no. 2, p. e4401, 2009.
B
G. Mutua, Farah, B., Langat, R., Indangasi, J., Ogola, S., Onsembe, B., Kopycinski, J. T., Hayes, P., Borthwick, N. J., Ashraf, A., Dally, L., Barin, B., Tillander, A., Gilmour, J., De Bont, J., Crook, A., Hannaman, D., Cox, J. H., Anzala, O., Fast, P. E., Reilly, M., Chinyenze, K., Jaoko, W., Hanke, T., and Group, T. Hiv- Core 0, “Broad HIV-1 inhibition in vitro by vaccine-elicited CD8(+) T cells in African adults.”, Mol Ther Methods Clin Dev, vol. 3, p. 16061, 2016.
W. Stevens, Kamali, A., Karita, E., Anzala, O., Sanders, E. J., Jaoko, W., Kaleebu, P., Mulenga, J., Dally, L., Fast, P., Gilmour, J., Farah, B., Birungi, J., Hughes, P., Manigart, O., Stevens, G., Yates, S., Thomson, H., von Lieven, A., Krebs, M., Price, M. A., Stoll-Johnson, L., and Ketter, N., “Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials.”, PLoS One, vol. 3, no. 4, p. e2043, 2008.