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Items: 14

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Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector.

Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team.

J Infect Dis. 2006 Dec 15;194(12):1638-49. Epub 2006 Nov 8. Erratum in: J Infect Dis. 2009 Oct 15;200(8):1352-3.

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Statistical evaluation of biomarkers as surrogate endpoints: a literature review.

Weir CJ, Walley RJ.

Stat Med. 2006 Jan 30;25(2):183-203. Review.

PMID:
16252272
5.

Correlation between immunologic responses to a recombinant glycoprotein 120 vaccine and incidence of HIV-1 infection in a phase 3 HIV-1 preventive vaccine trial.

Gilbert PB, Peterson ML, Follmann D, Hudgens MG, Francis DP, Gurwith M, Heyward WL, Jobes DV, Popovic V, Self SG, Sinangil F, Burke D, Berman PW.

J Infect Dis. 2005 Mar 1;191(5):666-77. Epub 2005 Jan 27.

6.

Sensitivity analysis for the assessment of causal vaccine effects on viral load in HIV vaccine trials.

Gilbert PB, Bosch RJ, Hudgens MG.

Biometrics. 2003 Sep;59(3):531-41.

PMID:
14601754
7.

Statistical challenges in the evaluation of surrogate endpoints in randomized trials.

Molenberghs G, Buyse M, Geys H, Renard D, Burzykowski T, Alonso A.

Control Clin Trials. 2002 Dec;23(6):607-25. Review.

PMID:
12505240
8.

Principal stratification in causal inference.

Frangakis CE, Rubin DB.

Biometrics. 2002 Mar;58(1):21-9.

9.

Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Friedman L, Gail MH, Prentice R, Wittes J, Zeger SL.

Control Clin Trials. 2001 Oct;22(5):485-502.

PMID:
11578783
10.

Exposure stratified case-cohort designs.

Borgan O, Langholz B, Samuelsen SO, Goldstein L, Pogoda J.

Lifetime Data Anal. 2000 Mar;6(1):39-58.

PMID:
10763560
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Estimating the proportion of treatment effect explained by a surrogate marker.

Lin DY, Fleming TR, De Gruttola V.

Stat Med. 1997 Jul 15;16(13):1515-27.

PMID:
9249922
13.

Regression calibration in failure time regression.

Wang CY, Hsu L, Feng ZD, Prentice RL.

Biometrics. 1997 Mar;53(1):131-45.

PMID:
9147589
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