Augmented HIV vaccine trial design for estimating reduction in infectiousness and protective efficacy

Statistics in Medicine

Volumn 17, Issue 2, 1998, Pages 185-200

  Datta, Susmita ^a,b   Halloran, M Elizabeth ^a   Longini Jr , Ira M ^a  

^a EMORY UNIVERSITY   (United States)

^b GEORGIA STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE; PLACEBO;

ARTICLE; DISEASE PREDISPOSITION; DRUG EFFICACY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; METHODOLOGY; PROBABILITY; RANDOMIZATION; SEXUALITY; STATISTICAL MODEL;

AIDS VACCINES; CLINICAL TRIALS, PHASE III; COMPUTER SIMULATION; HIV INFECTIONS; HUMANS; LIKELIHOOD FUNCTIONS; MODELS, STATISTICAL; PATIENT SELECTION; RANDOM ALLOCATION; RESEARCH DESIGN; SEXUAL PARTNERS;

EID: 0032579593     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19980130)17:2<185::AID-SIM732>3.0.CO;2-4     Document Type: Article

References (29)

1. Dixon, D. O., Rida, W. N., Fast, P. E. and Hoth, D. F. 'HIV vaccine trials: some design issues including sampling size calculations', Journal of the Acquired Immune Deficiency Syndrome, 6, 485-496 (1993).
2. Fleming, T. R. 'Intermediate-sized trials for the evaluation of HIV vaccine candidates (abstract)., in Conference on advances in AIDS vaccine development: 8th Annual Cooperative Vaccine Development Groups for AIDS Meeting Program book, National Institutes of Health, Bethsada, 1996, p. 108.
3. Halloran, M. E., Haber, M. J., Longini, I. M. and Struchiner, C. J. 'Direct and indirect effects in vaccine field efficacy and effectiveness', American Journal of Epidemiology, 133, 323-331 (1991).
4. Halloran, M. E., Struchiner, C. J. and Spielman, A. 'Modeling malaria vaccines II: Population effects of stage-specific malaria vaccines dependent on natural boosting', Mathematical Biosciences, 94, 115-149 (1989).
5. Halloran, M. E., Cochi, S., Lieu, T., Wharton, M. and Fehrs, L. 'Theoretical epidemiologic and morbidity effects of routine immunization of preschool children with live-virus varicella vaccine in the U.S.', American Journal of Epidemiology, 140, 81-104 (1994).
6. Halloran, M. E., Longini, I. M., Struchiner, C. J., Haber, M. J. and Brunet, R. C. 'Exposure efficacy and change in contact rates in evaluating prophylatic HIV vaccines in the field', Statistics in Medicine, 13, 357-377 (1994).
7. Halloran, M. E. and Struchiner, C. J. 'Causal inference for infectious diseases', Epidemiology, 61, 142-151 (1995).
8. Halloran, M. E. 'Evaluating HIV vaccines: Discussion', Statistics in Medicine, 15, 2405-2412 (1996).
9. DeGruttola, V., Seage, G. R., Mayer, K. H. and Horsburgh, C. R. 'Infectiousness of HIV between male homosexual partners', Journal of Clinical Epidemiology, 42, 849-856 (1989).
10. Wiley, J. A., Herschkorn, S. J. and Padian, N. S. 'Heterogeneity in the probability of HIV transmission per sexual contact: the case of male-to-female transmission in penile-vaginal intercourse', Statistics in Medicine, 8, 93-102 (1989).
11. Longini, I. M., Clark, W. S., Haber, M. J. and Horsburgh, R. C. The stages of HIV infection: Waiting times and infection transmission probabilities', Lecture Notes in Biomathematics, 83, 111-137 (1989).
12. Kim, M. Y. and Lagakos, S. W. 'Estimating the infectivity of HIV from partner studies', Annals of Epidemiology, 1, 117-128 (1990).
13. Jewell, N. P. and Shiboski, S. C. 'Statistical analysis of HIV infectivity based on partner study data', Biometrics, 46, 1133-1150 (1990).
14. Shiboski, S. C. and Jewell, N. P. 'Statistical analysis of the time-dependence on HIV infectivity based on partner study data', Journal of the American Statistical Association, 87, 360-372 (1992).
15. Koopman, J. S. and Little, R. J. 'Assessing HIV vaccine effects', American Journal of Epidermiology, 142, 1113-1120 (1995).
16. Longini, I. M. and Koopman, J. S. 'Household and community transmission parameters from final distributions of infections in households', Biometrics, 38, 115-126 (1982).
17. Rida, W. N. 'Assessing the effect on HIV vaccination on secondary transmission', Statistics in Medicine, 15, 2393-2404 (1996).
18. Longini, I. M., Datta, S. and Halloran, M. E. 'Measuring vaccine efficacy for both susceptibility to infection and reduction in infectiousness for prophylactic HIV-1 vaccines', Journal of Acquired Immune Deficiency Syndrome and Human Retrovirus, 13, 440-447 (1996).
19. Halloran, M. E. and Struchiner, C. J. 'Evaluating vaccine effects: changes in susceptibility, infectiousness, contacts, direct and indirect effects', in Proceeding of the III Brazilian/II Ibero American/Latin American Congress on Epidemiology, April, 1995.
20. Rhodes, P. H., Halloran, M. E. and Longini, I. M. 'Counting process models for differentiating exposure to infection and susceptibility', Journal of the Royal Statistical Society, Series B, 58, 751-762 (1996).
21. Greenwood, M. and Yule, U. G. 'The statistics of anti-typhoid and anti-cholera inoculations, and the interpretation of such statistics in general', Proceedings of the Royal Society of Medicine, 8 (part 2), 113-194 (1915).
22. Longini, I. M. and Halloran, M. E. 'A frailty mixture model for estimating vaccine efficacy', Applied Statistics, 45, 165-173 (1996).
23. Halloran, M. E., Longini, I. M. and Struchiner, C. J. 'Estimability and interpretation of vaccine efficacy using frailty mixing models', American Journal of Epidemiology, 144, 83-97 (1996).
24. Magder, L. and Brookmeyer, R. 'Analysis of infectious disease data from partners studies with unknown source of infection', Biometrics, 49, 1110-1116 (1993).
25. Smith, P. G., Rodrigues, L. C. and Fine, P. E. M. 'Assessment of the protective efficacy of vaccine against common diseases using case-control and cohort studies', International Journal of Epidemiology, 13, 87-93 (1984).
26. Halloran, M. E., Haber, M. J. and Longini, I. M. 'Interpretation and estimation of vaccine efficacy under heterogeneity', American Journal of Epidemiology, 136, 328-343 (1992).
27. Brunet, R. C., Struchiner, C. J. and Halloran, M. E. 'On the distribution of vaccine protection under heterogeneous response', Mathematical Biosciences, 116, 111-125 (1993).
28. Cohen, J. 'News and comment: Thailand weighs AIDS vaccine tests', Science, 270, 904-970 (1995).
29. Addy, C. L., Longini, I. M. and Haber, M. J. 'A generalized stochastic model for the analysis of infectious disease final size data', Biometrics, 47, 961-974 (1991).