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Items: 1 to 50 of 186

1.

Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors (HVTN 096): a phase 1b, double-blind, placebo-controlled trial.

Pantaleo G, Janes H, Karuna S, Grant S, Ouedraogo GL, Allen M, Tomaras GD, Frahm N, Montefiori DC, Ferrari G, Ding S, Lee C, Robb ML, Esteban M, Wagner R, Bart PA, Rettby N, McElrath MJ, Gilbert PB, Kublin JG, Corey L; NIAID HIV Vaccine Trials Network.

Lancet HIV. 2019 Oct 7. pii: S2352-3018(19)30262-0. doi: 10.1016/S2352-3018(19)30262-0. [Epub ahead of print]

PMID:
31601541
2.

Antibody Fc effector functions and IgG3 associate with decreased HIV-1 risk.

Neidich SD, Fong Y, Li SS, Geraghty DE, Williamson BD, Young WC, Goodman D, Seaton KE, Shen X, Sawant S, Zhang L, deCamp AC, Blette BS, Shao M, Yates NL, Feely F, Pyo CW, Ferrari G; HVTN 505 Team, Frank I, Karuna ST, Swann EM, Mascola JR, Graham BS, Hammer SM, Sobieszczyk ME, Corey L, Janes HE, McElrath MJ, Gottardo R, Gilbert PB, Tomaras GD.

J Clin Invest. 2019 Oct 7. pii: 126391. doi: 10.1172/JCI126391. [Epub ahead of print]

3.

Immune correlates of the Thai RV144 HIV vaccine regimen in South Africa.

Gray GE, Huang Y, Grunenberg N, Laher F, Roux S, Andersen-Nissen E, De Rosa SC, Flach B, Randhawa AK, Jensen R, Swann EM, Bekker LG, Innes C, Lazarus E, Morris L, Mkhize NN, Ferrari G, Montefiori DC, Shen X, Sawant S, Yates N, Hural J, Isaacs A, Phogat S, DiazGranados CA, Lee C, Sinangil F, Michael NL, Robb ML, Kublin JG, Gilbert PB, McElrath MJ, Tomaras GD, Corey L.

Sci Transl Med. 2019 Sep 18;11(510). pii: eaax1880. doi: 10.1126/scitranslmed.aax1880.

PMID:
31534016
4.

A Meta-analysis of Passive Immunization Studies Shows that Serum-Neutralizing Antibody Titer Associates with Protection against SHIV Challenge.

Pegu A, Borate B, Huang Y, Pauthner MG, Hessell AJ, Julg B, Doria-Rose NA, Schmidt SD, Carpp LN, Cully MD, Chen X, Shaw GM, Barouch DH, Haigwood NL, Corey L, Burton DR, Roederer M, Gilbert PB, Mascola JR, Huang Y.

Cell Host Microbe. 2019 Sep 11;26(3):336-346.e3. doi: 10.1016/j.chom.2019.08.014.

PMID:
31513771
5.

Fc gamma receptor polymorphisms modulated the vaccine effect on HIV-1 risk in the HVTN 505 HIV vaccine trial.

Li SS, Gilbert PB, Carpp LN, Pyo CW, Janes H, Fong Y, Shen X, Neidich SD, Goodman D, deCamp A, Cohen KW, Ferrari G, Hammer SM, Sobieszczyk ME, Mulligan MJ, Buchbinder SP, Keefer MC, DeJesus E, Novak RM, Frank I, McElrath MJ, Tomaras GD, Geraghty DE, Peng X.

J Virol. 2019 Aug 21. pii: JVI.02041-18. doi: 10.1128/JVI.02041-18. [Epub ahead of print]

PMID:
31434737
6.

Assessing pharmacokinetic marker correlates of outcome, with application to antibody prevention efficacy trials.

Gilbert PB, Zhang Y, Rudnicki E, Huang Y.

Stat Med. 2019 Oct 15;38(23):4503-4518. doi: 10.1002/sim.8310. Epub 2019 Jul 17.

PMID:
31313349
7.

NONPARAMETRIC INFERENCE FOR IMMUNE RESPONSE THRESHOLDS OF RISK IN VACCINE STUDIES.

Donovan KM, Hudgens MG, Gilbert PB.

Ann Appl Stat. 2019 Jun;13(2):1147-1165. doi: 10.1214/18-AOAS1237. Epub 2019 Jun 17.

PMID:
31285781
8.

Combining Viral Genetics and Statistical Modeling to Improve HIV-1 Time-of-infection Estimation towards Enhanced Vaccine Efficacy Assessment.

Rossenkhan R, Rolland M, Labuschagne JPL, Ferreira RC, Magaret CA, Carpp LN, Matsen Iv FA, Huang Y, Rudnicki EE, Zhang Y, Ndabambi N, Logan M, Holzman T, Abrahams MR, Anthony C, Tovanabutra S, Warth C, Botha G, Matten D, Nitayaphan S, Kibuuka H, Sawe FK, Chopera D, Eller LA, Travers S, Robb ML, Williamson C, Gilbert PB, Edlefsen PT.

Viruses. 2019 Jul 3;11(7). pii: E607. doi: 10.3390/v11070607.

9.

Simultaneous Inference of Treatment Effect Modification by Intermediate Response Endpoint Principal Strata with Application to Vaccine Trials.

Zhuang Y, Huang Y, Gilbert PB.

Int J Biostat. 2019 Jul 2. pii: /j/ijb.ahead-of-print/ijb-2018-0058/ijb-2018-0058.xml. doi: 10.1515/ijb-2018-0058. [Epub ahead of print]

PMID:
31265429
10.

Revisiting the Correlate of Reduced HIV Infection Risk in the Rv144 Vaccine Trial.

Zolla-Pazner S, Gilbert PB.

J Virol. 2019 Aug 13;93(17). pii: e00629-19. doi: 10.1128/JVI.00629-19. Print 2019 Sep 1.

PMID:
31189712
11.

HAI and NAI titer correlates of inactivated and live attenuated influenza vaccine efficacy.

Gilbert PB, Fong Y, Juraska M, Carpp LN, Monto AS, Martin ET, Petrie JG.

BMC Infect Dis. 2019 May 22;19(1):453. doi: 10.1186/s12879-019-4049-5.

12.

Bridging Efficacy of a Tetravalent Dengue Vaccine from Children/Adolescents to Adults in Highly Endemic Countries Based on Neutralizing Antibody Response.

Gilbert PB, Huang Y, Juraska M, Moodie Z, Fong Y, Luedtke A, Zhuang Y, Shao J, Carpp LN, Jackson N, Chambonneau L, Bouckenooghe A, Zambrano B, Frago C, Pallardy S, Noriega F.

Am J Trop Med Hyg. 2019 Jul;101(1):164-179. doi: 10.4269/ajtmh.18-0534.

PMID:
31115304
13.

Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials.

Janes H, Donnell D, Gilbert PB, Brown ER, Nason M.

Lancet HIV. 2019 Jul;6(7):e475-e482. doi: 10.1016/S2352-3018(19)30133-X. Epub 2019 May 8.

PMID:
31078451
14.

Prediction of VRC01 neutralization sensitivity by HIV-1 gp160 sequence features.

Magaret CA, Benkeser DC, Williamson BD, Borate BR, Carpp LN, Georgiev IS, Setliff I, Dingens AS, Simon N, Carone M, Simpkins C, Montefiori D, Alter G, Yu WH, Juraska M, Edlefsen PT, Karuna S, Mgodi NM, Edugupanti S, Gilbert PB.

PLoS Comput Biol. 2019 Apr 1;15(4):e1006952. doi: 10.1371/journal.pcbi.1006952. eCollection 2019 Apr.

15.

Integrated systems approach defines the antiviral pathways conferring protection by the RV144 HIV vaccine.

Fourati S, Ribeiro SP, Blasco Tavares Pereira Lopes F, Talla A, Lefebvre F, Cameron M, Kaewkungwal J, Pitisuttithum P, Nitayaphan S, Rerks-Ngarm S, Kim JH, Thomas R, Gilbert PB, Tomaras GD, Koup RA, Michael NL, McElrath MJ, Gottardo R, Sékaly RP.

Nat Commun. 2019 Feb 20;10(1):863. doi: 10.1038/s41467-019-08854-2.

16.

Smoothed Rank Regression for the Accelerated Failure Time Competing Risks Model with Missing Cause of Failure.

Qiu Z, Wan ATK, Zhou Y, Gilbert PB.

Stat Sin. 2019 Jan;29(1):23-46. doi: 10.5705/ss.202016.0231.

PMID:
30740005
17.

Methods for comparing durability of immune responses between vaccine regimens in early-phase trials.

Westling T, Juraska M, Seaton KE, Tomaras GD, Gilbert PB, Janes H.

Stat Methods Med Res. 2019 Jan 9:962280218820881. doi: 10.1177/0962280218820881. [Epub ahead of print]

PMID:
30623732
18.

Inference on treatment effect modification by biomarker response in a three-phase sampling design.

Juraska M, Huang Y, Gilbert PB.

Biostatistics. 2018 Dec 26. doi: 10.1093/biostatistics/kxy074. [Epub ahead of print]

PMID:
30590450
19.

Periods of high dengue transmission defined by rainfall do not impact efficacy of dengue vaccine in regions of endemic disease.

Pasin C, Halloran ME, Gilbert PB, Langevin E, Ochiai RL, Pitisuttithum P, Capeding MR, Carrasquilla G, Frago C, Cortés M, Chambonneau L, Moodie Z.

PLoS One. 2018 Dec 13;13(12):e0207878. doi: 10.1371/journal.pone.0207878. eCollection 2018.

20.

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.

21.

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.

22.

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.

23.

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.

24.

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.

25.

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. Review.

26.

Estimation of the optimal surrogate based on a randomized trial.

Price BL, Gilbert PB, van der Laan MJ.

Biometrics. 2018 Dec;74(4):1271-1281. doi: 10.1111/biom.12879. Epub 2018 Apr 27.

27.

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.

28.

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.

29.

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.

30.

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.

31.

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.

32.

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.

33.

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.

34.

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.

35.

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.

36.

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.

37.

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.

38.

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.

39.

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
40.

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.

41.

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.

42.

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.

43.

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.

44.

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.

45.

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.

46.
47.

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.

48.

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.

49.

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.

50.

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.

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