-
1
-
-
84926634007
-
Ending the Global HIV/AIDS Pandemic: The Critical Role of an HIV Vaccine
-
PMID:25151483
-
Fauci AS, Folkers GK, Marston HD. Ending the Global HIV/AIDS Pandemic: The Critical Role of an HIV Vaccine. Clin Infect Dis 2014; 59 Suppl 2: S80-4; PMID:25151483; http://dx. doi. org/10. 1093/cid/ ciu420.
-
(2014)
Clin Infect Dis
, vol.59
, pp. S80-S84
-
-
Fauci, A.S.1
Folkers, G.K.2
Marston, H.D.3
-
2
-
-
73349094086
-
Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand
-
PMID:19843557
-
Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med 2009; 361(23): 2209-20; PMID:19843557; http://dx. doi. org/10. 1056/ NEJMoa0908492.
-
(2009)
N Engl J Med
, vol.361
, Issue.23
, pp. 2209-2220
-
-
Rerks-Ngarm, S.1
Pitisuttithum, P.2
Nitayaphan, S.3
Kaewkungwal, J.4
Chiu, J.5
Paris, R.6
Premsri, N.7
Namwat, C.8
de Souza, M.9
Adams, E.10
-
3
-
-
79953019952
-
Statistical interpretation of the RV144 HIV vaccine efficacy trial in Thailand: A case study for statistical issues in efficacy trials
-
PMID:21402548
-
Gilbert PB, Berger JO, Stablein D, Becker S, Essex M, Hammer SM, Kim JH, Degruttola VG. Statistical interpretation of the RV144 HIV vaccine efficacy trial in Thailand: a case study for statistical issues in efficacy trials. J Infect Dis 2011; 203(7): 969-75; PMID:21402548; http://dx. doi. org/10. 1093/infdis/ jiq152.
-
(2011)
J Infect Dis
, vol.203
, Issue.7
, pp. 969-975
-
-
Gilbert, P.B.1
Berger, J.O.2
Stablein, D.3
Becker, S.4
Essex, M.5
Hammer, S.M.6
Kim, J.H.7
Degruttola, V.G.8
-
4
-
-
84862764447
-
Risk behaviour and time as covariates for efficacy of the HIV vaccine regimen ALVAC-HIV (vCP1521) and AIDSVAX B/E: A post-hoc analysis of the Thai phase 3 efficacy trial RV 144
-
PMID:22652344
-
Robb ML, Rerks-Ngarm S, Nitayaphan S, Pitisuttithum P, Kaewkungwal J, Kunasol P, Khamboonruang C, Thongcharoen P, Morgan P, Benenson M, et al. Risk behaviour and time as covariates for efficacy of the HIV vaccine regimen ALVAC-HIV (vCP1521) and AIDSVAX B/E: a post-hoc analysis of the Thai phase 3 efficacy trial RV 144. Lancet Infect Dis 2012; 12(7): 531-7; PMID:22652344; http://dx. doi. org/10. 1016/ S1473-3099(12)70088-9.
-
(2012)
Lancet Infect Dis
, vol.12
, Issue.7
, pp. 531-537
-
-
Robb, M.L.1
Rerks-Ngarm, S.2
Nitayaphan, S.3
Pitisuttithum, P.4
Kaewkungwal, J.5
Kunasol, P.6
Khamboonruang, C.7
Thongcharoen, P.8
Morgan, P.9
Benenson, M.10
-
5
-
-
84876414249
-
Vaccine and immunotherapeutic interventions
-
PMID:23478912
-
Pantaleo G, Levy Y. Vaccine and immunotherapeutic interventions. Curr Opin HIV AIDS 2013; 8(3): 236- 42; PMID:23478912; http://dx. doi. org/10. 1097/ COH. 0b013e32835fd5cd.
-
(2013)
Curr Opin HIV AIDS
, vol.8
, Issue.3
, pp. 236-242
-
-
Pantaleo, G.1
Levy, Y.2
-
6
-
-
84865830845
-
Can immunotherapy be useful as a "functional cure" for infection with Human Immunodeficiency Virus-1?
-
PMID:22958464
-
Vanham G, Van Gulck E. Can immunotherapy be useful as a "functional cure" for infection with Human Immunodeficiency Virus-1? Retrovirology 2012; 9: 72; PMID:22958464; http://dx. doi. org/10. 1186/1742- 4690-9-72.
-
(2012)
Retrovirology
, vol.9
, pp. 72
-
-
Vanham, G.1
Van Gulck, E.2
-
8
-
-
78650598765
-
The quest for a T cell-based immune correlate of protection against HIV: A story of trials and errors
-
PMID:21164527
-
Koup RA, Graham BS, Douek DC. The quest for a T cell-based immune correlate of protection against HIV: a story of trials and errors. Nat Rev Immunol 2011; 11 (1): 65-70; PMID:21164527; http://dx. doi. org/ 10. 1038/nri2890.
-
(2011)
Nat Rev Immunol
, vol.11
, Issue.1
, pp. 65-70
-
-
Koup, R.A.1
Graham, B.S.2
Douek, D.C.3
-
9
-
-
84859393693
-
Immune-correlates analysis of an HIV-1 vaccine efficacy trial
-
PMID:22475592
-
Haynes BF, Gilbert PB, McElrath MJ, Zolla-Pazner S, Tomaras GD, Alam SM, Evans DT, Montefiori DC, Karnasuta C, Sutthent R, et al. Immune-correlates analysis of an HIV-1 vaccine efficacy trial. N Engl J Med 2012; 366(14): 1275-86; PMID:22475592; http://dx. doi. org/10. 1056/NEJMoa1113425.
-
(2012)
N Engl J Med
, vol.366
, Issue.14
, pp. 1275-1286
-
-
Haynes, B.F.1
Gilbert, P.B.2
McElrath, M.J.3
Zolla-Pazner, S.4
Tomaras, G.D.5
Alam, S.M.6
Evans, D.T.7
Montefiori, D.C.8
Karnasuta, C.9
Sutthent, R.10
-
10
-
-
84903887355
-
Analysis of HLA A*02 Association with Vaccine Efficacy in the RV144 HIV-1 Vaccine Trial
-
PMID:24829343
-
Gartland AJ, Li S, McNevin J, Tomaras GD, Gottardo R, Janes H, Fong Y, Morris D, Geraghty DE, Kijak GH, et al. Analysis of HLA A*02 Association with Vaccine Efficacy in the RV144 HIV-1 Vaccine Trial. J Virol 2014; 88(15): 8242-55; PMID:24829343; http://dx. doi. org/10. 1128/ JVI. 01164-14.
-
(2014)
J Virol
, vol.88
, Issue.15
, pp. 8242-8255
-
-
Gartland, A.J.1
Li, S.2
McNevin, J.3
Tomaras, G.D.4
Gottardo, R.5
Janes, H.6
Fong, Y.7
Morris, D.8
Geraghty, D.E.9
Kijak, G.H.10
-
11
-
-
77951619664
-
Some design issues in phase 2B vs phase 3 prevention trials for testing efficacy of products or concepts
-
PMID:20419758
-
Gilbert PB. Some design issues in phase 2B vs phase 3 prevention trials for testing efficacy of products or concepts. Stat Med 2010; 29(10): 1061-71; PMID:20419758; http://dx. doi. org/10. 1002/ sim. 3676.
-
(2010)
Stat Med
, vol.29
, Issue.10
, pp. 1061-1071
-
-
Gilbert, P.B.1
-
12
-
-
84876072776
-
A sequential phase 2b trial design for evaluating vaccine efficacy and immune correlates for multiple HIV vaccine regimens
-
PMID:23181167
-
Gilbert PB, Grove D, Gabriel E, Huang Y, Gray G, Hammer SM, Buchbinder SP, Kublin J, Corey L, Self SG. A sequential phase 2b trial design for evaluating vaccine efficacy and immune correlates for multiple HIV vaccine regimens. Stat Commun Infect Dis 2011; 3(1):1037; PMID:23181167.
-
(2011)
Stat Commun Infect Dis
, vol.3
, Issue.1
, pp. 1037
-
-
Gilbert, P.B.1
Grove, D.2
Gabriel, E.3
Huang, Y.4
Gray, G.5
Hammer, S.M.6
Buchbinder, S.P.7
Kublin, J.8
Corey, L.9
Self, S.G.10
-
13
-
-
56649105122
-
Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): A double- blind, randomised, placebo-controlled, test-ofconcept trial
-
PMID:19012954
-
Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double- blind, randomised, placebo-controlled, test-ofconcept trial. Lancet 2008; 372(9653): 1881-93; PMID:19012954; http://dx. doi. org/10. 1016/S0140- 6736(08)61591-3.
-
(2008)
Lancet
, vol.372
, Issue.9653
, pp. 1881-1893
-
-
Buchbinder, S.P.1
Mehrotra, D.V.2
Duerr, A.3
Fitzgerald, D.W.4
Mogg, R.5
Li, D.6
Gilbert, P.B.7
Lama, J.R.8
Marmor, M.9
Del Rio, C.10
-
14
-
-
79959301474
-
Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: A double-blind, randomised, placebo-controlled test-of-concept phase 2b study
-
PMID:21570355
-
Gray GE, Allen M, Moodie Z, Churchyard G, Bekker LG, Nchabeleng M, Mlisana K, Metch B, de Bruyn G, Latka MH, et al. Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study. Lancet Infect Dis 2011; 11(7): 507-15; PMID:21570355; http://dx. doi. org/ 10. 1016/S1473-3099(11)70098-6.
-
(2011)
Lancet Infect Dis
, vol.11
, Issue.7
, pp. 507-515
-
-
Gray, G.E.1
Allen, M.2
Moodie, Z.3
Churchyard, G.4
Bekker, L.G.5
Nchabeleng, M.6
Mlisana, K.7
Metch, B.8
de Bruyn, G.9
Latka, M.H.10
-
15
-
-
84861057293
-
Nomenclature for immune correlates of protection after vaccination
-
PMID:22437237
-
Plotkin SA, Gilbert PB. Nomenclature for immune correlates of protection after vaccination. Clin Infect Dis 2012; 54(11): 1615-7; PMID:22437237; http:// dx. doi. org/10. 1093/cid/cis238.
-
(2012)
Clin Infect Dis
, vol.54
, Issue.11
, pp. 1615-1617
-
-
Plotkin, S.A.1
Gilbert, P.B.2
-
16
-
-
38449106454
-
A framework for assessing immunological correlates of protection in vaccine trials
-
PMID:17922394
-
Qin L, Gilbert PB, Corey L, McElrath MJ, Self SG. A framework for assessing immunological correlates of protection in vaccine trials. J Infect Dis 2007; 196(9): 1304-12; PMID:17922394; http://dx. doi. org/ 10. 1086/522428.
-
(2007)
J Infect Dis
, vol.196
, Issue.9
, pp. 1304-1312
-
-
Qin, L.1
Gilbert, P.B.2
Corey, L.3
McElrath, M.J.4
Self, S.G.5
-
17
-
-
53849099349
-
Evaluating a surrogate endpoint at three levels, with application to vaccine development
-
PMID:17979212
-
Gilbert PB, Qin L, Self SG. Evaluating a surrogate endpoint at three levels, with application to vaccine development. Stat Med 2008; 27(23): 4758-78; PMID:17979212; http://dx. doi. org/10. 1002/ sim. 3122.
-
(2008)
Stat Med
, vol.27
, Issue.23
, pp. 4758-4778
-
-
Gilbert, P.B.1
Qin, L.2
Self, S.G.3
-
18
-
-
84904396633
-
Potential role for HIV-specific CD38-/ HLA-DR+ CD8+ T cells in viral suppression and cytotoxicity in HIV controllers
-
PMID:25000587
-
Hua S, Lecuroux C, Saez-Cirion A, Pancino G, Girault I, Versmisse P, Boufassa F, Taulera O, Sinet M, Lambotte O, et al. Potential role for HIV-specific CD38-/ HLA-DR+ CD8+ T cells in viral suppression and cytotoxicity in HIV controllers. PloS one 2014; 9(7): e101920; PMID:25000587; http://dx. doi. org/ 10. 1371/journal. pone. 0101920.
-
(2014)
PloS one
, vol.9
, Issue.7
-
-
Hua, S.1
Lecuroux, C.2
Saez-Cirion, A.3
Pancino, G.4
Girault, I.5
Versmisse, P.6
Boufassa, F.7
Taulera, O.8
Sinet, M.9
Lambotte, O.10
-
19
-
-
34249852256
-
HIV controllers exhibit potent CD8 T cell capacity to suppress HIV infection ex vivo and peculiar cytotoxic T lymphocyte activation phenotype
-
PMID:17428922
-
Saez-Cirion A, Lacabaratz C, Lambotte O, Versmisse P, Urrutia A, Boufassa F, Barré-Sinoussi F, Delfraissy JF, Sinet M, Pancino G, et al. HIV controllers exhibit potent CD8 T cell capacity to suppress HIV infection ex vivo and peculiar cytotoxic T lymphocyte activation phenotype. Proc Natl Acad Sci USA 2007; 104(16): 6776-81; PMID:17428922; http://dx. doi. org/ 10. 1073/pnas. 0611244104.
-
(2007)
Proc Natl Acad Sci USA
, vol.104
, Issue.16
, pp. 6776-6781
-
-
Saez-Cirion, A.1
Lacabaratz, C.2
Lambotte, O.3
Versmisse, P.4
Urrutia, A.5
Boufassa, F.6
Barré-Sinoussi, F.7
Delfraissy, J.F.8
Sinet, M.9
Pancino, G.10
-
20
-
-
37049027525
-
Preserved central memory and activated effector memory CD4+ T-cell subsets in human immunodeficiency virus controllers: An ANRS EP36 study
-
PMID:17928341
-
Potter SJ, Lacabaratz C, Lambotte O, Perez-Patrigeon S, Vingert B, Sinet M, Colle JH, Urrutia A, Scott- Algara D, Boufassa F, et al. Preserved central memory and activated effector memory CD4+ T-cell subsets in human immunodeficiency virus controllers: an ANRS EP36 study. J Virol 2007; 81(24): 13904-15; PMID:17928341; http://dx. doi. org/10. 1128/ JVI. 01401-07.
-
(2007)
J Virol
, vol.81
, Issue.24
, pp. 13904-13915
-
-
Potter, S.J.1
Lacabaratz, C.2
Lambotte, O.3
Perez-Patrigeon, S.4
Vingert, B.5
Sinet, M.6
Colle, J.H.7
Urrutia, A.8
Scott-Algara, D.9
Boufassa, F.10
-
21
-
-
0024520844
-
Surrogate endpoints in clinical trials: Definition and operational criteria
-
PMID:2727467
-
Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989; 8(4): 431-40; PMID:2727467; http://dx. doi. org/10. 1002/ sim. 4780080407.
-
(1989)
Stat Med
, vol.8
, Issue.4
, pp. 431-440
-
-
Prentice, R.L.1
-
22
-
-
84856482137
-
Vaccine protection against acquisition of neutralization-resistant SIV challenges in rhesus monkeys
-
PMID:22217938
-
Barouch DH, Liu J, Li H, Maxfield LF, Abbink P, Lynch DM, Iampietro MJ, SanMiguel A, Seaman MS, Ferrari G, et al. Vaccine protection against acquisition of neutralization-resistant SIV challenges in rhesus monkeys. Nature 2012; 482(7383): 89-93; PMID:22217938; http://dx. doi. org/10. 1038/ nature10766.
-
(2012)
Nature
, vol.482
, Issue.7383
, pp. 89-93
-
-
Barouch, D.H.1
Liu, J.2
Li, H.3
Maxfield, L.F.4
Abbink, P.5
Lynch, D.M.6
Iampietro, M.J.7
SanMiguel, A.8
Seaman, M.S.9
Ferrari, G.10
-
23
-
-
61949216736
-
Effector memory T cell responses are associated with protection of rhesus monkeys from mucosal simian immunodeficiency virus challenge
-
PMID:19219024
-
Hansen SG, Vieville C, Whizin N, Coyne-Johnson L, Siess DC, Drummond DD, Legasse AW, Axthelm MK, Oswald K, Trubey CM, et al. Effector memory T cell responses are associated with protection of rhesus monkeys from mucosal simian immunodeficiency virus challenge. Nat Med 2009; 15(3): 293-9; PMID:19219024; http://dx. doi. org/10. 1038/ nm. 1935.
-
(2009)
Nat Med
, vol.15
, Issue.3
, pp. 293-299
-
-
Hansen, S.G.1
Vieville, C.2
Whizin, N.3
Coyne-Johnson, L.4
Siess, D.C.5
Drummond, D.D.6
Legasse, A.W.7
Axthelm, M.K.8
Oswald, K.9
Trubey, C.M.10
-
24
-
-
84863191097
-
Measurements of immune responses for establishing correlates of vaccine protection against HIV
-
PMID:21861777
-
Burgers WA, Manrique A, Masopust D, McKinnon LR, Reynolds MR, Rolland M, Blish C, Chege GK, Curran R, Fischer W, et al. Measurements of immune responses for establishing correlates of vaccine protection against HIV. AIDS Res Hum Retroviruses 2012; 28(7): 641-8; PMID:21861777; http://dx. doi. org/ 10. 1089/aid. 2011. 0239.
-
(2012)
AIDS Res Hum Retroviruses
, vol.28
, Issue.7
, pp. 641-648
-
-
Burgers, W.A.1
Manrique, A.2
Masopust, D.3
McKinnon, L.R.4
Reynolds, M.R.5
Rolland, M.6
Blish, C.7
Chege, G.K.8
Curran, R.9
Fischer, W.10
-
25
-
-
84859438491
-
Adaptive clinical trials in oncology
-
Berry DA. Adaptive clinical trials in oncology. Nat Rev Clin Oncol 2012; 9(4): 199-207; http://dx. doi. org/ 10. 1038/nrclinonc. 2011. 165.
-
(2012)
Nat Rev Clin Oncol
, vol.9
, Issue.4
, pp. 199-207
-
-
Berry, D.A.1
-
26
-
-
79960239432
-
Designing phase II trials in cancer: A systematic review and guidance
-
PMID:21712822
-
Brown SR, Gregory WM, Twelves CJ, Buyse M, Collinson F, Parmar M, Seymour MT, Brown JM, et al. Designing phase II trials in cancer: a systematic review and guidance. Br J Cancer 2011; 105(2): 194-9; PMID:21712822; http://dx. doi. org/10. 1038/ bjc. 2011. 235.
-
(2011)
Br J Cancer
, vol.105
, Issue.2
, pp. 194-199
-
-
Brown, S.R.1
Gregory, W.M.2
Twelves, C.J.3
Buyse, M.4
Collinson, F.5
Parmar, M.6
Seymour, M.T.7
Brown, J.M.8
-
27
-
-
33846243782
-
A 25-year review of sequential methodology in clinical studies
-
PMID:17139691
-
Todd S. A 25-year review of sequential methodology in clinical studies. Stat Med 2007; 26(2): 237-52; PMID:17139691; http://dx. doi. org/10. 1002/ sim. 2763.
-
(2007)
Stat Med
, vol.26
, Issue.2
, pp. 237-252
-
-
Todd, S.1
-
29
-
-
84887865083
-
Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine
-
PMID:24099601
-
Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, et al. Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine. N Engl J Med 2013; 369(22): 2083-92; PMID:24099601; http://dx. doi. org/10. 1056/NEJMoa1310566.
-
(2013)
N Engl J Med
, vol.369
, Issue.22
, pp. 2083-2092
-
-
Hammer, S.M.1
Sobieszczyk, M.E.2
Janes, H.3
Karuna, S.T.4
Mulligan, M.J.5
Grove, D.6
Koblin, B.A.7
Buchbinder, S.P.8
Keefer, M.C.9
Tomaras, G.D.10
-
31
-
-
84865271518
-
Adaptive trial designs: A review of barriers and opportunities
-
PMID:22917111
-
Kairalla JA, Coffey CS, Thomann MA, Muller KE. Adaptive trial designs: a review of barriers and opportunities. Trials 2012; 13: 145; PMID:22917111; http:// dx. doi. org/10. 1186/1745-6215-13-145.
-
(2012)
Trials
, vol.13
, pp. 145
-
-
Kairalla, J.A.1
Coffey, C.S.2
Thomann, M.A.3
Muller, K.E.4
-
32
-
-
77954875817
-
-
Silver Spring, Maryland: Food and Drug Administration (FDA); last accessed March 4, 2015
-
US. Department of Health and Human Services. Draft guidance for industry: adaptive design clinical trials for drugs and biologics. Silver Spring, Maryland: Food and Drug Administration (FDA); 2010. http://www. fda. gov/downloads/Drugs/Guidances/ucm201790. pdf, last accessed March 4, 2015.
-
(2010)
Draft guidance for industry: Adaptive design clinical trials for drugs and biologics.
-
-
-
33
-
-
84862249598
-
Adaptive clinical trials: A partial remedy for the therapeutic misconception?
-
PMID:22692168
-
Meurer WJ, Lewis RJ, Berry DA. Adaptive clinical trials: a partial remedy for the therapeutic misconception? JAMA 2012; 307(22): 2377-8; PMID:22692168; http://dx. doi. org/10. 1001/jama. 2012. 4174.
-
(2012)
JAMA
, vol.307
, Issue.22
, pp. 2377-2378
-
-
Meurer, W.J.1
Lewis, R.J.2
Berry, D.A.3
-
34
-
-
84862257264
-
Adaptive trials in clinical research: Scientific and ethical issues to consider
-
PMID:22692169
-
van der Graaf R, Roes KC, van Delden JJ. Adaptive trials in clinical research: scientific and ethical issues to consider. JAMA 2012; 307(22): 2379-80; PMID:22692169; http://dx. doi. org/10. 1001/ jama. 2012. 6380.
-
(2012)
JAMA
, vol.307
, Issue.22
, pp. 2379-2380
-
-
van der Graaf, R.1
Roes, K.C.2
van Delden, J.J.3
-
35
-
-
79955016281
-
HIV-1 vaccines and adaptive trial designs
-
PMID:21508308
-
Corey L, Nabel GJ, Dieffenbach C, Gilbert P, Haynes BF, Johnston M, Kublin J, Lane HC, Pantaleo G, Picker LJ, et al. HIV-1 vaccines and adaptive trial designs. Sci Transl Med 2011; 3(79): 79ps13; PMID:21508308; http://dx. doi. org/10. 1126/ scitranslmed. 3001863.
-
(2011)
Sci Transl Med
, vol.3
, Issue.79
-
-
Corey, L.1
Nabel, G.J.2
Dieffenbach, C.3
Gilbert, P.4
Haynes, B.F.5
Johnston, M.6
Kublin, J.7
Lane, H.C.8
Pantaleo, G.9
Picker, L.J.10
-
36
-
-
84873506978
-
Designing tomorrow's vaccines
-
PMID:23388006
-
Nabel GJ. Designing tomorrow's vaccines. N Engl J Med 2013; 368(6): 551-60; PMID:23388006; http:// dx. doi. org/10. 1056/NEJMra1204186.
-
(2013)
N Engl J Med
, vol.368
, Issue.6
, pp. 551-560
-
-
Nabel, G.J.1
-
37
-
-
33845484073
-
Augmented designs to assess immune response in vaccine trials
-
PMID:17156291
-
Follmann D. Augmented designs to assess immune response in vaccine trials. Biometrics 2006; 62(4): 1161-9; PMID:17156291; http://dx. doi. org/10. 1111/ j. 1541-0420. 2006. 00569. x.
-
(2006)
Biometrics
, vol.62
, Issue.4
, pp. 1161-1169
-
-
Follmann, D.1
-
38
-
-
79957604683
-
AIDS vaccines and preexposure prophylaxis: Is synergy possible?
-
PMID:21043994
-
Excler JL, Rida W, Priddy F, Gilmour J, McDermott AB, Kamali A, Anzala O, Mutua G, Sanders EJ, Koff W, et al. AIDS vaccines and preexposure prophylaxis: is synergy possible? AIDS Res Hum Retroviruses 2011; 27(6): 669-80; PMID:21043994; http://dx. doi. org/ 10. 1089/aid. 2010. 0206.
-
(2011)
AIDS Res Hum Retroviruses
, vol.27
, Issue.6
, pp. 669-680
-
-
Excler, J.L.1
Rida, W.2
Priddy, F.3
Gilmour, J.4
McDermott, A.B.5
Kamali, A.6
Anzala, O.7
Mutua, G.8
Sanders, E.J.9
Koff, W.10
-
39
-
-
84883456464
-
In pursuit of an HIV vaccine: Designing efficacy trials in the context of partially effective nonvaccine prevention modalities
-
PMID:23597282
-
Janes H, Gilbert P, Buchbinder S, Kublin J, Sobieszczyk ME, Hammer SM. In pursuit of an HIV vaccine: designing efficacy trials in the context of partially effective nonvaccine prevention modalities. AIDS Res Hum Retroviruses 2013; 29(11): 1513-23; PMID:23597282; http://dx. doi. org/10. 1089/ aid. 2012. 0385.
-
(2013)
AIDS Res Hum Retroviruses
, vol.29
, Issue.11
, pp. 1513-1523
-
-
Janes, H.1
Gilbert, P.2
Buchbinder, S.3
Kublin, J.4
Sobieszczyk, M.E.5
Hammer, S.M.6
-
40
-
-
84883461399
-
New clinical trial designs for HIV vaccine evaluation
-
PMID:23872613
-
Moodie Z, Janes H, Huang Y. New clinical trial designs for HIV vaccine evaluation. Curr Opin HIV AIDS 2013; 8(5): 437-42; PMID:23872613; http://dx. doi. org/10. 1097/COH. 0b013e328363d46a.
-
(2013)
Curr Opin HIV AIDS
, vol.8
, Issue.5
, pp. 437-442
-
-
Moodie, Z.1
Janes, H.2
Huang, Y.3
-
41
-
-
84886772838
-
Challenges in clinical trial design for HIV-1 cure research
-
PMID:24182529
-
Eyal N, Kuritzkes DR. Challenges in clinical trial design for HIV-1 cure research. Lancet 2013; 382 (9903): 1464-5; PMID:24182529; http://dx. doi. org/ 10. 1016/S0140-6736(13)62040-1.
-
(2013)
Lancet
, vol.382
, Issue.9903
, pp. 1464-1465
-
-
Eyal, N.1
Kuritzkes, D.R.2
-
42
-
-
33645332079
-
Statistical evaluation of HIV vaccines in early clinical trials
-
PMID:16426900
-
Moodie Z, Rossini AJ, Hudgens MG, Gilbert PB, Self SG, Russell ND. Statistical evaluation of HIV vaccines in early clinical trials. Contemp Clin Trials 2006; 27 (2): 147-60; PMID:16426900; http://dx. doi. org/ 10. 1016/j. cct. 2005. 11. 008.
-
(2006)
Contemp Clin Trials
, vol.27
, Issue.2
, pp. 147-160
-
-
Moodie, Z.1
Rossini, A.J.2
Hudgens, M.G.3
Gilbert, P.B.4
Self, S.G.5
Russell, N.D.6
-
43
-
-
84896717212
-
Accelerating clinical development of HIV vaccine strategies: Methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design
-
Vaccine Research Institute (VRI) PMID:24571662
-
Richert L, Doussau A, Lelievre JD, Arnold V, Rieux V, Bouakane A, Lévy Y, Chêne G, Thiébaut R; Vaccine Research Institute (VRI). Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design. Trials 2014; 15: 68; PMID:24571662; http://dx. doi. org/10. 1186/1745- 6215-15-68.
-
(2014)
Trials
, vol.15
, pp. 68
-
-
Richert, L.1
Doussau, A.2
Lelievre, J.D.3
Arnold, V.4
Rieux, V.5
Bouakane, A.6
Lévy, Y.7
Chêne, G.8
Thiébaut, R.9
-
44
-
-
34248149301
-
Optimization and validation of an 8-color intracellular cytokine staining (ICS) assay to quantify antigen-specific T cells induced by vaccination
-
PMID:17451739
-
Horton H, Thomas EP, Stucky JA, Frank I, Moodie Z, Huang Y, Chiu YL, McElrath MJ, De Rosa SC. Optimization and validation of an 8-color intracellular cytokine staining (ICS) assay to quantify antigen-specific T cells induced by vaccination. J Immunol Methods 2007; 323(1): 39-54; PMID:17451739; http://dx. doi. org/10. 1016/j. jim. 2007. 03. 002.
-
(2007)
J Immunol Methods
, vol.323
, Issue.1
, pp. 39-54
-
-
Horton, H.1
Thomas, E.P.2
Stucky, J.A.3
Frank, I.4
Moodie, Z.5
Huang, Y.6
Chiu, Y.L.7
McElrath, M.J.8
De Rosa, S.C.9
-
45
-
-
2942568229
-
Statistical considerations for the design and analysis of the ELISpot assay in HIV-1 vaccine trials
-
PMID:15183082
-
Hudgens MG, Self SG, Chiu YL, Russell ND, Horton H, McElrath MJ. Statistical considerations for the design and analysis of the ELISpot assay in HIV-1 vaccine trials. J Immunol Methods 2004; 288(1-2): 19-34; PMID:15183082; http://dx. doi. org/10. 1016/j. jim. 2004. 01. 018.
-
(2004)
J Immunol Methods
, vol.288
, Issue.1-2
, pp. 19-34
-
-
Hudgens, M.G.1
Self, S.G.2
Chiu, Y.L.3
Russell, N.D.4
Horton, H.5
McElrath, M.J.6
-
46
-
-
33748879767
-
Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials
-
PMID:16959262
-
Moodie Z, Huang Y, Gu L, Hural J, Self SG. Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials. J Immunol Methods 2006; 315(1-2): 121-32; PMID:16959262; http://dx. doi. org/ 10. 1016/j. jim. 2006. 07. 015.
-
(2006)
J Immunol Methods
, vol.315
, Issue.1-2
, pp. 121-132
-
-
Moodie, Z.1
Huang, Y.2
Gu, L.3
Hural, J.4
Self, S.G.5
-
47
-
-
84880043712
-
Defining ELISpot cut-offs from unreplicated test and control wells
-
PMID:23500146
-
Alexander N, Fox A, Lien VT, Dong T, Lee LY, Hang Nle K, Mai le Q, Horby P. Defining ELISpot cut-offs from unreplicated test and control wells. J Immunol Methods 2013; 392(1-2): 57-62; PMID:23500146; http://dx. doi. org/10. 1016/j. jim. 2013. 02. 014.
-
(2013)
J Immunol Methods
, vol.392
, Issue.1-2
, pp. 57-62
-
-
Alexander, N.1
Fox, A.2
Lien, V.T.3
Dong, T.4
Lee, L.Y.5
Hang Nle, K.6
le Mai, Q.7
Horby, P.8
-
48
-
-
84890485060
-
Mixture models for single-cell assays with applications to vaccine studies
-
PMID:23887981
-
Finak G, McDavid A, Chattopadhyay P, Dominguez M, De Rosa S, Roederer M, Gottardo R. Mixture models for single-cell assays with applications to vaccine studies. Biostatistics 2014; 15(1): 87-101; PMID:23887981; http://dx. doi. org/10. 1093/ biostatistics/kxt024.
-
(2014)
Biostatistics
, vol.15
, Issue.1
, pp. 87-101
-
-
Finak, G.1
McDavid, A.2
Chattopadhyay, P.3
Dominguez, M.4
De Rosa, S.5
Roederer, M.6
Gottardo, R.7
-
49
-
-
84879109018
-
Is the current use of 'positivity' thresholds meaningful for evaluating HIV-vaccine immunogenicity endpoints?
-
PMID:23759712
-
Richert L, Thiebaut R. Is the current use of 'positivity' thresholds meaningful for evaluating HIV-vaccine immunogenicity endpoints? AIDS 2013; 27(8): 1362- 5; PMID:23759712; http://dx. doi. org/10. 1097/ QAD. 0b013e328360d52e.
-
(2013)
AIDS
, vol.27
, Issue.8
, pp. 1362-1365
-
-
Richert, L.1
Thiebaut, R.2
-
50
-
-
57649217611
-
Efficient and robust method for comparing the immunogenicity of candidate vaccines in randomized clinical trials
-
PMID:19022314
-
Gilbert PB, Sato A, Sun X, Mehrotra DV. Efficient and robust method for comparing the immunogenicity of candidate vaccines in randomized clinical trials. Vaccine 2009; 27(3): 396-401; PMID:19022314; http:// dx. doi. org/10. 1016/j. vaccine. 2008. 10. 083.
-
(2009)
Vaccine
, vol.27
, Issue.3
, pp. 396-401
-
-
Gilbert, P.B.1
Sato, A.2
Sun, X.3
Mehrotra, D.V.4
-
51
-
-
84871671305
-
A robust bayesian random effects model for nonlinear calibration problems
-
PMID:22551415
-
Fong Y, Wakefield J, De Rosa S, Frahm N. A robust bayesian random effects model for nonlinear calibration problems. Biometrics 2012; 68(4): 1103-12; PMID:22551415; http://dx. doi. org/10. 1111/j. 1541- 0420. 2012. 01762. x.
-
(2012)
Biometrics
, vol.68
, Issue.4
, pp. 1103-1112
-
-
Fong, Y.1
Wakefield, J.2
De Rosa, S.3
Frahm, N.4
-
52
-
-
77952922044
-
Simultaneous Evaluation of the Magnitude and Breadth of a Left and Right Censored Multivariate Response, with Application to HIV Vaccine Development
-
PMID:20072667
-
Huang Y, Gilbert PB, Montefiori DC, Self SG. Simultaneous Evaluation of the Magnitude and Breadth of a Left and Right Censored Multivariate Response, with Application to HIV Vaccine Development. Stat Biopharm Res 2009; 1(1): 81-91; PMID:20072667; http://dx. doi. org/10. 1198/sbr. 2009. 0008.
-
(2009)
Stat Biopharm Res
, vol.1
, Issue.1
, pp. 81-91
-
-
Huang, Y.1
Gilbert, P.B.2
Montefiori, D.C.3
Self, S.G.4
-
53
-
-
84903381095
-
From empiricism to rational design: A personal perspective of the evolution of vaccine development
-
PMID:24925139
-
De Gregorio E, Rappuoli R. From empiricism to rational design: a personal perspective of the evolution of vaccine development. Nat Rev Immunol 2014; 14(7): 505-14; PMID:24925139; http://dx. doi. org/10. 1038/ nri3694.
-
(2014)
Nat Rev Immunol
, vol.14
, Issue.7
, pp. 505-514
-
-
De Gregorio, E.1
Rappuoli, R.2
-
54
-
-
84907841767
-
Dendritic cell-based therapeutic vaccine elicits polyfunctional HIV-specific T-cell immunity associated with control of viral load
-
PMID: 25042008; Epub ahead of print
-
Levy Y, Thiebaut R, Montes M, Lacabaratz C, Sloan L, King B, Pérusat S, Harrod C, Cobb A, Roberts LK, et al. Dendritic cell-based therapeutic vaccine elicits polyfunctional HIV-specific T-cell immunity associated with control of viral load. Eur J Immunol 2014; 44 (9):2802-10; PMID: 25042008; Epub ahead of print.
-
(2014)
Eur J Immunol
, vol.44
, Issue.9
, pp. 2802-2810
-
-
Levy, Y.1
Thiebaut, R.2
Montes, M.3
Lacabaratz, C.4
Sloan, L.5
King, B.6
Pérusat, S.7
Harrod, C.8
Cobb, A.9
Roberts, L.K.10
-
55
-
-
16244388225
-
Models of Phase 1 vaccine trials: Optimization of trial design to minimize risks of multiple serious adverse events
-
PMID:15811654
-
Saul A. Models of Phase 1 vaccine trials: optimization of trial design to minimize risks of multiple serious adverse events. Vaccine 2005; 23(23): 3068-75; PMID:15811654; http://dx. doi. org/10. 1016/j. vaccine. 2004. 10. 048.
-
(2005)
Vaccine
, vol.23
, Issue.23
, pp. 3068-3075
-
-
Saul, A.1
-
56
-
-
84901660865
-
Quantifying and predicting the effect of exogenous interleukin-7 on CD4+ T cells in HIV-1 infection
-
PMID:24853554
-
Thiebaut R, Drylewicz J, Prague M, Lacabaratz C, Beq S, Jarne A, Croughs T, Sekaly RP, Lederman MM, Sereti I, et al. Quantifying and predicting the effect of exogenous interleukin-7 on CD4+ T cells in HIV-1 infection. PLoS Comput Biol 2014; 10(5): e1003630; PMID:24853554; http://dx. doi. org/10. 1371/journal. pcbi. 1003630.
-
(2014)
PLoS Comput Biol
, vol.10
, Issue.5
-
-
Thiebaut, R.1
Drylewicz, J.2
Prague, M.3
Lacabaratz, C.4
Beq, S.5
Jarne, A.6
Croughs, T.7
Sekaly, R.P.8
Lederman, M.M.9
Sereti, I.10
-
57
-
-
67650850418
-
Model predictive control of type 1 diabetes: An in silico trial
-
PMID:19885152
-
Magni L, Raimondo DM, Bossi L, Man CD, De Nicolao G, Kovatchev B, Cobelli C. Model predictive control of type 1 diabetes: an in silico trial. J Diabetes Sci Technol 2007; 1(6): 804-12; PMID:19885152; http:// dx. doi. org/10. 1177/193229680700100603.
-
(2007)
J Diabetes Sci Technol
, vol.1
, Issue.6
, pp. 804-812
-
-
Magni, L.1
Raimondo, D.M.2
Bossi, L.3
Man, C.D.4
De Nicolao, G.5
Kovatchev, B.6
Cobelli, C.7
-
58
-
-
84555216185
-
Results of a multicentric in silico clinical trial (ROCOCO): Comparing radiotherapy with photons and protons for non-small cell lung cancer
-
ROCOCO Consortium PMID:22071782
-
Roelofs E, Engelsman M, Rasch C, Persoon L, Qamhiyeh S, de Ruysscher D, Verhaegen F, Pijls-Johannesma M, Lambin P; ROCOCO Consortium. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-small cell lung cancer. J Thorac Oncol 2012; 7(1): 165-76; PMID:22071782; http://dx. doi. org/10. 1097/ JTO. 0b013e31823529fc.
-
(2012)
J Thorac Oncol
, vol.7
, Issue.1
, pp. 165-176
-
-
Roelofs, E.1
Engelsman, M.2
Rasch, C.3
Persoon, L.4
Qamhiyeh, S.5
de Ruysscher, D.6
Verhaegen, F.7
Pijls-Johannesma, M.8
Lambin, P.9
-
59
-
-
33845433434
-
Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand
-
PMID:17109337
-
Pitisuttithum P, Gilbert P, Gurwith M, Heyward W, Martin M, van Griensven F, Hu D, Tappero JW, Choopanya K; Bangkok Vaccine Evaluation Group. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. J Infect Dis 2006; 194(12): 1661-71; PMID:17109337; http://dx. doi. org/10. 1086/508748.
-
(2006)
J Infect Dis
, vol.194
, Issue.12
, pp. 1661-1671
-
-
Pitisuttithum, P.1
Gilbert, P.2
Gurwith, M.3
Heyward, W.4
Martin, M.5
van Griensven, F.6
Hu, D.7
Tappero, J.W.8
Choopanya, K.9
-
60
-
-
13944254982
-
Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection
-
PMID:15688278
-
Flynn NM, Forthal DN, Harro CD, Judson FN, Mayer KH, Para MF. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis 2005; 191(5): 654-65; PMID:15688278; http://dx. doi. org/10. 1086/428404.
-
(2005)
J Infect Dis
, vol.191
, Issue.5
, pp. 654-665
-
-
Flynn, N.M.1
Forthal, D.N.2
Harro, C.D.3
Judson, F.N.4
Mayer, K.H.5
Para, M.F.6
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