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Items: 1 to 50 of 167

1.

Statistical Learning Methods to Determine Immune Correlates of Herpes Zoster in Vaccine Efficacy Trials.

Gilbert PB, Luedtke AR.

J Infect Dis. 2018 Sep 22;218(suppl_2):S99-S101. doi: 10.1093/infdis/jiy421.

PMID:
30247601
2.

Viral genetic diversity and protective efficacy of a tetravalent dengue vaccine in two phase 3 trials.

Juraska M, Magaret CA, Shao J, Carpp LN, Fiore-Gartland AJ, Benkeser D, Girerd-Chambaz Y, Langevin E, Frago C, Guy B, Jackson N, Duong Thi Hue K, Simmons CP, Edlefsen PT, Gilbert PB.

Proc Natl Acad Sci U S A. 2018 Sep 4;115(36):E8378-E8387. doi: 10.1073/pnas.1714250115. Epub 2018 Aug 20.

PMID:
30127007
3.

Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial.

Bekker LG, Moodie Z, Grunenberg N, Laher F, Tomaras GD, Cohen KW, Allen M, Malahleha M, Mngadi K, Daniels B, Innes C, Bentley C, Frahm N, Morris DE, Morris L, Mkhize NN, Montefiori DC, Sarzotti-Kelsoe M, Grant S, Yu C, Mehra VL, Pensiero MN, Phogat S, DiazGranados CA, Barnett SW, Kanesa-Thasan N, Koutsoukos M, Michael NL, Robb ML, Kublin JG, Gilbert PB, Corey L, Gray GE, McElrath MJ; HVTN 100 Protocol Team.

Lancet HIV. 2018 Jul;5(7):e366-e378. doi: 10.1016/S2352-3018(18)30071-7. Epub 2018 Jun 18.

4.

Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy.

Sridhar S, Luedtke A, Langevin E, Zhu M, Bonaparte M, Machabert T, Savarino S, Zambrano B, Moureau A, Khromava A, Moodie Z, Westling T, Mascareñas C, Frago C, Cortés M, Chansinghakul D, Noriega F, Bouckenooghe A, Chen J, Ng SP, Gilbert PB, Gurunathan S, DiazGranados CA.

N Engl J Med. 2018 Jul 26;379(4):327-340. doi: 10.1056/NEJMoa1800820. Epub 2018 Jun 13.

5.

Analysis of Generalized Semiparametric Regression Models for Cumulative Incidence Functions with Missing Covariates.

Lee U, Sun Y, Scheike TH, Gilbert PB.

Comput Stat Data Anal. 2018 Jun;122:59-79. doi: 10.1016/j.csda.2018.01.003. Epub 2018 Feb 2.

PMID:
29892140
6.

Weighing the Evidence of Efficacy of Oral PrEP for HIV Prevention in Women in Southern Africa.

Janes H, Corey L, Ramjee G, Carpp LN, Lombard C, Cohen MS, Gilbert PB, Gray GE.

AIDS Res Hum Retroviruses. 2018 Aug;34(8):645-656. doi: 10.1089/AID.2018.0031. Epub 2018 Jun 19.

PMID:
29732896
7.

Estimation of the optimal surrogate based on a randomized trial.

Price BL, Gilbert PB, van der Laan MJ.

Biometrics. 2018 Apr 27. doi: 10.1111/biom.12879. [Epub ahead of print]

PMID:
29701875
8.

Modeling cumulative overall prevention efficacy for the VRC01 phase 2b efficacy trials.

Huang Y, Karuna S, Carpp LN, Reeves D, Pegu A, Seaton K, Mayer K, Schiffer J, Mascola J, Gilbert PB.

Hum Vaccin Immunother. 2018;14(9):2116-2127. doi: 10.1080/21645515.2018.1462640. Epub 2018 May 24.

9.

Projected effectiveness and added value of HIV vaccination campaigns in South Africa: A modeling study.

de Montigny S, Adamson BJS, Mâsse BR, Garrison LP Jr, Kublin JG, Gilbert PB, Dimitrov DT.

Sci Rep. 2018 Apr 17;8(1):6066. doi: 10.1038/s41598-018-24268-4.

10.

Hypothesis tests for stratified mark-specific proportional hazards models with missing covariates, with application to HIV vaccine efficacy trials.

Sun Y, Qi L, Yang G, Gilbert PB.

Biom J. 2018 May;60(3):516-536. doi: 10.1002/bimj.201700002. Epub 2018 Feb 28.

PMID:
29488249
11.

Doubly robust nonparametric inference on the average treatment effect.

Benkeser D, Carone M, Laan MJV, Gilbert PB.

Biometrika. 2017 Dec;104(4):863-880. doi: 10.1093/biomet/asx053. Epub 2017 Oct 16.

PMID:
29430041
12.

Modification of the Association Between T-Cell Immune Responses and Human Immunodeficiency Virus Type 1 Infection Risk by Vaccine-Induced Antibody Responses in the HVTN 505 Trial.

Fong Y, Shen X, Ashley VC, Deal A, Seaton KE, Yu C, Grant SP, Ferrari G, deCamp AC, Bailer RT, Koup RA, Montefiori D, Haynes BF, Sarzotti-Kelsoe M, Graham BS, Carpp LN, Hammer SM, Sobieszczyk M, Karuna S, Swann E, DeJesus E, Mulligan M, Frank I, Buchbinder S, Novak RM, McElrath MJ, Kalams S, Keefer M, Frahm NA, Janes HE, Gilbert PB, Tomaras GD.

J Infect Dis. 2018 Mar 28;217(8):1280-1288. doi: 10.1093/infdis/jiy008.

13.

Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.

Gilbert PB, Juraska M, deCamp AC, Karuna S, Edupuganti S, Mgodi N, Donnell DJ, Bentley C, Sista N, Andrew P, Isaacs A, Huang Y, Zhang L, Capparelli E, Kochar N, Wang J, Eshleman SH, Mayer KH, Magaret CA, Hural J, Kublin JG, Gray G, Montefiori DC, Gomez MM, Burns DN, McElrath J, Ledgerwood J, Graham BS, Mascola JR, Cohen M, Corey L.

Stat Commun Infect Dis. 2017 Jan;9(1). pii: 20160001. doi: 10.1515/scid-2016-0001. Epub 2017 Jun 6.

14.

Neutralizing Antibody Correlates Analysis of Tetravalent Dengue Vaccine Efficacy Trials in Asia and Latin America.

Moodie Z, Juraska M, Huang Y, Zhuang Y, Fong Y, Carpp LN, Self SG, Chambonneau L, Small R, Jackson N, Noriega F, Gilbert PB.

J Infect Dis. 2018 Feb 14;217(5):742-753. doi: 10.1093/infdis/jix609.

PMID:
29194547
15.

Sieve analysis of breakthrough HIV-1 sequences in HVTN 505 identifies vaccine pressure targeting the CD4 binding site of Env-gp120.

deCamp AC, Rolland M, Edlefsen PT, Sanders-Buell E, Hall B, Magaret CA, Fiore-Gartland AJ, Juraska M, Carpp LN, Karuna ST, Bose M, LePore S, Miller S, O'Sullivan A, Poltavee K, Bai H, Dommaraju K, Zhao H, Wong K, Chen L, Ahmed H, Goodman D, Tay MZ, Gottardo R, Koup RA, Bailer R, Mascola JR, Graham BS, Roederer M, O'Connell RJ, Michael NL, Robb ML, Adams E, D'Souza P, Kublin J, Corey L, Geraghty DE, Frahm N, Tomaras GD, McElrath MJ, Frenkel L, Styrchak S, Tovanabutra S, Sobieszczyk ME, Hammer SM, Kim JH, Mullins JI, Gilbert PB.

PLoS One. 2017 Nov 17;12(11):e0185959. doi: 10.1371/journal.pone.0185959. eCollection 2017.

16.

chngpt: threshold regression model estimation and inference.

Fong Y, Huang Y, Gilbert PB, Permar SR.

BMC Bioinformatics. 2017 Oct 16;18(1):454. doi: 10.1186/s12859-017-1863-x.

17.

A joint model for mixed and truncated longitudinal data and survival data, with application to HIV vaccine studies.

Yu T, Wu L, Gilbert PB.

Biostatistics. 2018 Jul 1;19(3):374-390. doi: 10.1093/biostatistics/kxx047.

PMID:
29028943
18.

DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8+ T-Cell Responses by Interleukin-12 Plasmid DNA.

Li SS, Kochar NK, Elizaga M, Hay CM, Wilson GJ, Cohen KW, De Rosa SC, Xu R, Ota-Setlik A, Morris D, Finak G, Allen M, Tieu HV, Frank I, Sobieszczyk ME, Hannaman D, Gottardo R, Gilbert PB, Tomaras GD, Corey L, Clarke DK, Egan MA, Eldridge JH, McElrath MJ, Frahm N; NIAID HIV Vaccine Trials Network.

Clin Vaccine Immunol. 2017 Nov 6;24(11). pii: e00263-17. doi: 10.1128/CVI.00263-17. Print 2017 Nov.

19.

Estimation of Stratified Mark-Specific Proportional Hazards Models under Two-Phase Sampling with Application to HIV Vaccine Efficacy Trials.

Yang G, Sun Y, Qi L, Gilbert PB.

Stat Biosci. 2017 Jun;9(1):259-283. doi: 10.1007/s12561-016-9177-5. Epub 2016 Oct 27.

20.

Comparing and combining biomarkers as principal surrogates for time-to-event clinical endpoints.

Gabriel EE, Sachs MC, Gilbert PB.

Stat Med. 2017 Sep 20;36(21):3440. doi: 10.1002/sim.7354. Epub 2017 May 22. No abstract available.

PMID:
28776727
21.

Immunogenicity of a novel Clade B HIV-1 vaccine combination: Results of phase 1 randomized placebo controlled trial of an HIV-1 GM-CSF-expressing DNA prime with a modified vaccinia Ankara vaccine boost in healthy HIV-1 uninfected adults.

Buchbinder SP, Grunenberg NA, Sanchez BJ, Seaton KE, Ferrari G, Moody MA, Frahm N, Montefiori DC, Hay CM, Goepfert PA, Baden LR, Robinson HL, Yu X, Gilbert PB, McElrath MJ, Huang Y, Tomaras GD; HIV Vaccine Trials Network (HVTN) 094 Study Group.

PLoS One. 2017 Jul 20;12(7):e0179597. doi: 10.1371/journal.pone.0179597. eCollection 2017.

22.

Improved estimation of the cumulative incidence of rare outcomes.

Benkeser D, Carone M, Gilbert PB.

Stat Med. 2018 Jan 30;37(2):280-293. doi: 10.1002/sim.7337. Epub 2017 Jul 2.

PMID:
28670687
23.

Antibody to HSV gD peptide induced by vaccination does not protect against HSV-2 infection in HSV-2 seronegative women.

Gilbert PB, Excler JL, Tomaras GD, Carpp LN, Haynes BF, Liao HX, Montefiori DC, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Kijak GH, Tovanabutra S, Francis DP, Lee C, Sinangil F, Berman PW, Premsri N, Kunasol P, O'Connell RJ, Michael NL, Robb ML, Morrow R, Corey L, Kim JH.

PLoS One. 2017 May 11;12(5):e0176428. doi: 10.1371/journal.pone.0176428. eCollection 2017.

24.

SieveSifter: a web-based tool for visualizing the sieve analyses of HIV-1 vaccine efficacy trials.

Fiore-Gartland A, Kullman N, deCamp AC, Clenaghan G, Yang W, Magaret CA, Edlefsen PT, Gilbert PB.

Bioinformatics. 2017 Aug 1;33(15):2386-2388. doi: 10.1093/bioinformatics/btx168.

25.

Population pharmacokinetics analysis of VRC01, an HIV-1 broadly neutralizing monoclonal antibody, in healthy adults.

Huang Y, Zhang L, Ledgerwood J, Grunenberg N, Bailer R, Isaacs A, Seaton K, Mayer KH, Capparelli E, Corey L, Gilbert PB.

MAbs. 2017 Jul;9(5):792-800. doi: 10.1080/19420862.2017.1311435. Epub 2017 Apr 3.

26.

Higher T-Cell Responses Induced by DNA/rAd5 HIV-1 Preventive Vaccine Are Associated With Lower HIV-1 Infection Risk in an Efficacy Trial.

Janes HE, Cohen KW, Frahm N, De Rosa SC, Sanchez B, Hural J, Magaret CA, Karuna S, Bentley C, Gottardo R, Finak G, Grove D, Shen M, Graham BS, Koup RA, Mulligan MJ, Koblin B, Buchbinder SP, Keefer MC, Adams E, Anude C, Corey L, Sobieszczyk M, Hammer SM, Gilbert PB, McElrath MJ.

J Infect Dis. 2017 May 1;215(9):1376-1385. doi: 10.1093/infdis/jix086.

27.
28.

Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials.

Huang Y, Zhang L, Janes H, Frahm N, Isaacs A, Kim JH, Montefiori D, McElrath MJ, Tomaras GD, Gilbert PB.

Vaccine. 2017 Feb 22;35(8):1184-1193. doi: 10.1016/j.vaccine.2016.09.053. Epub 2017 Jan 25.

29.

Peptide Targeted by Human Antibodies Associated with HIV Vaccine-Associated Protection Assumes a Dynamic α-Helical Structure.

Aiyegbo MS, Shmelkov E, Dominguez L, Goger M, Battacharya S, deCamp AC, Gilbert PB, Berman PW, Cardozo T.

PLoS One. 2017 Jan 20;12(1):e0170530. doi: 10.1371/journal.pone.0170530. eCollection 2017.

30.

Generalized semiparametric varying-coefficient model for longitudinal data with applications to adaptive treatment randomizations.

Qi L, Sun Y, Gilbert PB.

Biometrics. 2017 Jun;73(2):441-451. doi: 10.1111/biom.12626. Epub 2016 Dec 5.

31.

Model-robust inference for continuous threshold regression models.

Fong Y, Di C, Huang Y, Gilbert PB.

Biometrics. 2017 Jun;73(2):452-462. doi: 10.1111/biom.12623. Epub 2016 Nov 17.

32.

Brief Report: Preventing HIV-1 Infection in Women Using Oral Preexposure Prophylaxis: A Meta-analysis of Current Evidence.

Hanscom B, Janes HE, Guarino PD, Huang Y, Brown ER, Chen YQ, Hammer SM, Gilbert PB, Donnell DJ.

J Acquir Immune Defic Syndr. 2016 Dec 15;73(5):606-608.

33.

A study of vaccine-induced immune pressure on breakthrough infections in the Phambili phase 2b HIV-1 vaccine efficacy trial.

Hertz T, Logan MG, Rolland M, Magaret CA, Rademeyer C, Fiore-Gartland A, Edlefsen PT, DeCamp A, Ahmed H, Ngandu N, Larsen BB, Frahm N, Marais J, Thebus R, Geraghty D, Hural J, Corey L, Kublin J, Gray G, McElrath MJ, Mullins JI, Gilbert PB, Williamson C.

Vaccine. 2016 Nov 11;34(47):5792-5801. doi: 10.1016/j.vaccine.2016.09.054. Epub 2016 Oct 15.

34.

Modeling HIV vaccine trials of the future.

Gilbert PB, Huang Y, Janes HE.

Curr Opin HIV AIDS. 2016 Nov;11(6):620-627. Review.

35.

Statistical methods for down-selection of treatment regimens based on multiple endpoints, with application to HIV vaccine trials.

Huang Y, Gilbert PB, Fu R, Janes H.

Biostatistics. 2017 Apr 1;18(2):230-243. doi: 10.1093/biostatistics/kxw043.

36.

Sequential Immunization with gp140 Boosts Immune Responses Primed by Modified Vaccinia Ankara or DNA in HIV-Uninfected South African Participants.

Churchyard G, Mlisana K, Karuna S, Williamson AL, Williamson C, Morris L, Tomaras GD, De Rosa SC, Gilbert PB, Gu N, Yu C, Mkhize NN, Hermanus T, Allen M, Pensiero M, Barnett SW, Gray G, Bekker LG, Montefiori DC, Kublin J, Corey L.

PLoS One. 2016 Sep 1;11(9):e0161753. doi: 10.1371/journal.pone.0161753. eCollection 2016.

37.

Power/sample size calculations for assessing correlates of risk in clinical efficacy trials.

Gilbert PB, Janes HE, Huang Y.

Stat Med. 2016 Sep 20;35(21):3745-59. doi: 10.1002/sim.6952. Epub 2016 Mar 31.

38.

FCGR2C Polymorphisms Associated with HIV-1 Vaccine Protection Are Linked to Altered Gene Expression of Fc-γ Receptors in Human B Cells.

Peng X, Li SS, Gilbert PB, Geraghty DE, Katze MG.

PLoS One. 2016 Mar 25;11(3):e0152425. doi: 10.1371/journal.pone.0152425. eCollection 2016.

39.

Joint modeling of longitudinal and survival data with the Cox model and two-phase sampling.

Fu R, Gilbert PB.

Lifetime Data Anal. 2017 Jan;23(1):136-159. doi: 10.1007/s10985-016-9364-1. Epub 2016 Mar 23.

40.

Analysis of two-phase sampling data with semiparametric additive hazards models.

Sun Y, Qian X, Shou Q, Gilbert PB.

Lifetime Data Anal. 2017 Jul;23(3):377-399. doi: 10.1007/s10985-016-9363-2. Epub 2016 Mar 19.

41.

Pooled-Peptide Epitope Mapping Strategies Are Efficient and Highly Sensitive: An Evaluation of Methods for Identifying Human T Cell Epitope Specificities in Large-Scale HIV Vaccine Efficacy Trials.

Fiore-Gartland A, Manso BA, Friedrich DP, Gabriel EE, Finak G, Moodie Z, Hertz T, De Rosa SC, Frahm N, Gilbert PB, McElrath MJ.

PLoS One. 2016 Feb 10;11(2):e0147812. doi: 10.1371/journal.pone.0147812. eCollection 2016.

42.

Search continues for a CMV vaccine for transplant recipients.

Boeckh M, Gilbert PB.

Lancet Haematol. 2016 Feb;3(2):e58-9. doi: 10.1016/S2352-3026(15)00286-0. Epub 2015 Dec 24. No abstract available.

PMID:
26853642
43.

Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.

Huang Y, DiazGranados C, Janes H, Huang Y, deCamp AC, Metch B, Grant S, Sanchez B, Phogat S, Koutsoukos M, Kanesa-Thasan N, Bourguignon P, Collard A, Buchbinder S, Tomaras GD, McElrath J, Gray G, Kublin JG, Corey L, Gilbert PB.

Curr Opin Virol. 2016 Apr;17:57-65. doi: 10.1016/j.coviro.2016.01.007. Epub 2016 Jan 29. Review.

44.

Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.

Gilbert PB, Gabriel EE, Huang Y, Chan IS.

J Causal Inference. 2015 Sep 1;3(2):157-175. Epub 2015 Feb 1.

45.

Safety and Immunogenicity of a Recombinant Adenovirus Serotype 35-Vectored HIV-1 Vaccine in Adenovirus Serotype 5 Seronegative and Seropositive Individuals.

Fuchs JD, Bart PA, Frahm N, Morgan C, Gilbert PB, Kochar N, DeRosa SC, Tomaras GD, Wagner TM, Baden LR, Koblin BA, Rouphael NG, Kalams SA, Keefer MC, Goepfert PA, Sobieszczyk ME, Mayer KH, Swann E, Liao HX, Haynes BF, Graham BS, McElrath MJ; NIAID HIV Vaccine Trials Network.

J AIDS Clin Res. 2015 May;6(5). pii: 461. Epub 2015 May 23.

46.

Mark-specific hazard ratio model with missing multivariate marks.

Juraska M, Gilbert PB.

Lifetime Data Anal. 2016 Oct;22(4):606-25. doi: 10.1007/s10985-015-9353-9. Epub 2015 Oct 28.

47.

Immune correlates of vaccine protection against HIV-1 acquisition.

Corey L, Gilbert PB, Tomaras GD, Haynes BF, Pantaleo G, Fauci AS.

Sci Transl Med. 2015 Oct 21;7(310):310rv7. doi: 10.1126/scitranslmed.aac7732. Review.

48.

Genetic Diversity and Protective Efficacy of the RTS,S/AS01 Malaria Vaccine.

Neafsey DE, Juraska M, Bedford T, Benkeser D, Valim C, Griggs A, Lievens M, Abdulla S, Adjei S, Agbenyega T, Agnandji ST, Aide P, Anderson S, Ansong D, Aponte JJ, Asante KP, Bejon P, Birkett AJ, Bruls M, Connolly KM, D'Alessandro U, Dobaño C, Gesase S, Greenwood B, Grimsby J, Tinto H, Hamel MJ, Hoffman I, Kamthunzi P, Kariuki S, Kremsner PG, Leach A, Lell B, Lennon NJ, Lusingu J, Marsh K, Martinson F, Molel JT, Moss EL, Njuguna P, Ockenhouse CF, Ogutu BR, Otieno W, Otieno L, Otieno K, Owusu-Agyei S, Park DJ, Pellé K, Robbins D, Russ C, Ryan EM, Sacarlal J, Sogoloff B, Sorgho H, Tanner M, Theander T, Valea I, Volkman SK, Yu Q, Lapierre D, Birren BW, Gilbert PB, Wirth DF.

N Engl J Med. 2015 Nov 19;373(21):2025-2037. doi: 10.1056/NEJMoa1505819. Epub 2015 Oct 21.

49.

Goodness-of-fit test of the stratified mark-specific proportional hazards model with continuous mark.

Sun Y, Li M, Gilbert PB.

Comput Stat Data Anal. 2016 Jan 1;93:348-358. Epub 2014 Dec 3.

50.

Continued Follow-Up of Phambili Phase 2b Randomized HIV-1 Vaccine Trial Participants Supports Increased HIV-1 Acquisition among Vaccinated Men.

Moodie Z, Metch B, Bekker LG, Churchyard G, Nchabeleng M, Mlisana K, Laher F, Roux S, Mngadi K, Innes C, Mathebula M, Allen M, Bentley C, Gilbert PB, Robertson M, Kublin J, Corey L, Gray GE.

PLoS One. 2015 Sep 14;10(9):e0137666. doi: 10.1371/journal.pone.0137666. eCollection 2015.

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