Evaluation of operational chronic infection endpoints for HCV vaccine trials

Contemporary Clinical Trials

Volumn 29, Issue 5, 2008, Pages 671-678

  Kang, Minhee ^a   Nicolay, Uwe ^b  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b Novartis Vaccine   (Germany)

Author keywords

HCV; Log rank test; Multi state process; Vaccine efficacy

Indexed keywords

HEPATITIS VACCINE; VIRUS RNA;

ACUTE DISEASE; ANALYTICAL ERROR; ARTICLE; CHRONIC DISEASE; CHRONIC HEPATITIS; DIAGNOSTIC ERROR; DIFFERENTIAL DIAGNOSIS; DISEASE COURSE; DRUG EFFICACY; HEPATITIS C; HEPATITIS C VIRUS; LIVER CARCINOMA; LIVER CIRRHOSIS; LOG RANK TEST; MATHEMATICAL ANALYSIS; PROBABILITY; RNA ANALYSIS; THEORETICAL MODEL; VACCINE PRODUCTION; VIRUS DETECTION;

BIOLOGICAL MARKERS; CHRONIC DISEASE; ENDPOINT DETERMINATION; HEPATITIS C; HUMANS; MARKOV CHAINS; MODELS, STATISTICAL; VIRAL HEPATITIS VACCINES;

EID: 49749125576     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2008.03.006     Document Type: Article

References (27)

1. Global surveillance and control of hepatitis C. Report of a WHO Consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepatitis 6 1 (1999) 35-47
2. Alter M.J., Kruszon-Moran D., Nainan O.V., et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med 341 8 (1999) 556-562
3. Nainan O.V., Alter M.J., Kruszon-Moran D., et al. Hepatitis C virus genotypes and viral concentrations in participants of a general population survey in the United States. Gastroenterology 131 2 (2006) 478-484
4. Kuiken C., Mizokami M., Deleage G., et al. Hepatitis C databases, principles and utility to researchers. Hepatology 43 5 (2006) 1157-1165
5. Flamm S.L. Chronic hepatitis C virus infection. Jama 289 18 (2003) 2413-2417
6. Alter M.J., and Moyer L.A. The importance of preventing hepatitis C virus infection among injection drug users in the United States. J Acquir Immune Defic Syndr Human Retrovirol 18 Suppl 1 (1998) S6-S10
7. Cox A.L., Netski D.M., Mosbruger T., et al. Prospective evaluation of community-acquired acute-phase hepatitis C virus infection. Clin Infect Dis 40 7 (2005) 951-958
8. Amin J., Law M.G., Micallef J., et al. Potential biases in estimates of hepatitis C RNA clearance in newly acquired hepatitis C infection among a cohort of injecting drug users. Epidemiol Infect 135 1 (2007) 144-150
9. Rustgi V.K. The epidemiology of hepatitis C infection in the United States. J Gastroenterol 42 7 (2007) 513-521
10. Garfein R.S., Doherty M.C., Monterroso E.R., et al. Prevalence and incidence of hepatitis C virus infection among young adult injection drug users. J Acquir Immune Defic Syndr Human Retrovirol 18 Suppl 1 (1998) S11-S19
11. Miller C.L., Johnston C., Spittal P.M., et al. Opportunities for prevention: hepatitis C prevalence and incidence in a cohort of young injection drug users. Hepatology 36 3 (2002) 737-742
12. Smith R.E. Hepatitis C virus therapies. Nat Rev Drug Discov 5 9 (2006) 715-716
13. Chevaliez S., and Pawlotsky J.M. Hepatitis C virus serologic and virologic tests and clinical diagnosis of HCV-related liver disease. Int J Med Sci 3 2 (2006) 35-40
14. Firbas C., Jilma B., Tauber E., et al. Immunogenicity and safety of a novel therapeutic hepatitis C virus (HCV) peptide vaccine: a randomized, placebo controlled trial for dose optimization in 128 healthy subjects. Vaccine 24 20 (2006) 4343-4353
15. Wintermeyer P., and Wands J.R. Vaccines to prevent chronic hepatitis C virus infection: current experimental and preclinical developments. J Gastroenterol 42 6 (2007) 424-432
16. Houghton M., and Abrignani S. Prospects for a vaccine against the hepatitis C virus. Nature 436 7053 (2005) 961-966
17. Chen S.L., and Morgan T.R. The natural history of hepatitis C virus (HCV) infection. Int J Med Sci 3 2 (2006) 47-52
18. Kang M., and Lagakos S.W. Evaluation of log-rank tests for infrequent observations from a multi-state process, with application to HPV vaccine efficacy. Stat Med 23 23 (2004) 3681-3696
19. Cox D.R., and Miller H.D. The theory of stochastic processes (1987), Chapman and Hall, London
20. Hagan H., Thiede H., Weiss N.S., et al. Sharing of drug preparation equipment as a risk factor for hepatitis C. Am J Public Health 91 1 (2001) 42-46
21. Hagan H., Thiede H., and Des Jarlais D.C. Hepatitis C virus infection among injection drug users: survival analysis of time to seroconversion. Epidemiology 15 5 (2004) 543-549
22. Thorpe L.E., Ouellet L.J., Hershow R., et al. Risk of hepatitis C virus infection among young adult injection drug users who share injection equipment. Am J Epidemiol 155 7 (2002) 645-653
23. Kamal S.M., Moustafa K.N., Chen J., et al. Duration of peginterferon therapy in acute hepatitis C: a randomized trial. Hepatology 43 5 (2006) 923-931
24. Krajden M., Ziermann R., Khan A., et al. Qualitative detection of hepatitis C virus RNA: comparison of analytical sensitivity, clinical performance, and workflow of the Cobas Amplicor HCV test version 2.0 and the HCV RNA transcription-mediated amplification qualitative assay. J Clin Microbiol 40 8 (2002) 2903-2907
25. Pawlotsky J.M. Use and interpretation of virological tests for hepatitis C. Hepatology 36 5 Suppl 1 (2002) S65-S73
26. Freedman L.S. Tables of the number of patients required in clinical trials using the logrank test. Stat Med 1 2 (1982) 121-129
27. Kang M., and Lagakos S.W. Evaluating the role of human papillomavirus vaccine in cervical cancer prevention. Stat Methods Med Res 13 2 (2004) 139-155