Portal de Periódicos da CAPES

The Statistical Analysis of Immunognicity Data in Vaccine atials

1995; Wiley; Volume: 754; Issue: 1 Linguagem: Inglês

10.1111/j.1749-6632.1995.tb44466.x

1749-6632

Amelia Dale Horne,

Monoclonal and Polyclonal Antibodies Research

Annals of the New York Academy of SciencesVolume 754, Issue 1 p. 329-346 The Statistical Analysis of Immunognicity Data in Vaccine atials A Review of Methodologies and Issues AMELIA DALE HORNE, AMELIA DALE HORNE Division of Biostatistics and Epidemiology (HFM-215) Center for Biologics Evaluation and Research United States Food and Drug Administration 1401 Rockville Pike Rockville, Maryland 20852 The views expressed in this paper are those of the author and not necessarily of the United States Food and Drug Administration.Search for more papers by this author AMELIA DALE HORNE, AMELIA DALE HORNE Division of Biostatistics and Epidemiology (HFM-215) Center for Biologics Evaluation and Research United States Food and Drug Administration 1401 Rockville Pike Rockville, Maryland 20852 The views expressed in this paper are those of the author and not necessarily of the United States Food and Drug Administration.Search for more papers by this author First published: May 1995 https://doi.org/10.1111/j.1749-6632.1995.tb44466.xCitations: 12 AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat References 1 Baker, C. J., D. L. Kasper, M. S. Edwards & G. Schiffman 1980. Influence of preimmunization antibody levels on the specificity of the immune response to related polysaccharide antigens. N. Engl. J. Med. 303(4): 173–178. 2 Decker, M. D., K. M. Edwards, R. Bradley & P. Palmer 1992. Comparative trial in infants of four conjugate haemophilas influenzae type b vaccines. J. Pediatr. 120(2): 184–189. 3 Oratz, R., M. Dungan, D. F. Roses, M. N. Harris, J. L. Speyer, H. Hochster, J. Weissman, M. Henn & J-C. Bystryn 1991. Lack of effect of cyclophosphamide on the immunogenicity of a melanoma antigen vaccine. Cancer Res. 51(14): 3643–3647. 4 Parke, J. C., R. Schneerson, C. Reimer, C. Black, S. Welfare, D. Bryla, L. Levi, D. Pavliakova, T. Cramton, D. Schulz, M. Cadoz & J. B. Robbins 1991. Clinical and immunologic responses to haemophilus influenzae type b-tetanus toxoid conjugate vaccine in infants injected at 3, 5, 7, and 18 months of age. J. Pediatr. 118(2): 184–190. 5 Sperber, S. J., B. V. Smith & F. G. Hayden 1992. Serologic response and reactogenicity to booster immunization of healthy seropositive adults with live or inactivated varicella vaccine. Antiviral Research 17: 213–222. 6 Cooper, B. W., J. J. Klimek, A. Upadhyaya & S. Devine 1986. Poor seroconversion rate after hepatitis b vaccination in high-risk institutionalized mentally retarded patients. Am. J. Infect. Control 14(5): 204–208. 7 Ammann, A. J., J. Addiego, D. W. Wara, B. Lubin, W. B. Smith & W. C. Mentzer 1977. Polyvalent pneumococcal-polysaccharide immunization of patients with sickle-cell anemia and patients with splenectomy. N. Engl. J. Med. 297(17): 897–900. 8 Benhamou, E., A-M. Courouche, P. Jungers, A. Laplanche, F. Degos, J. Brangier & J. Crosnier 1984. Hepatitis b vaccine: Randomized trial of immunogenicity in hemodialysis patients. Clin. Nephrol. 21(3): 143–147. 9 Clemens, J. D., B. F. Stanton, J. Chakraborty, D. A. Sack, M. R. Khan, H. F. Ahmed, J. R. Harris, M. Yunus, M. U. Khan, A-M. Svennerholm, M. Jertborn & J. Holmgren 1987. B Subunit-whole cell and whole cell-only oral vaccines against cholera: Studies on reactogenicity and immunogenicity. J. Infect. Dis. 155(1): 79–85. 10 Cowan, M. J., A. J. Ammann, D. W. Wara, V. M. Howie, L. Schultz, N. Doyle & M. Kaplan 1978. Pneumococcal polysaccharide immunization in infants and children. Pediatrics 62(5): 721–727. 11 Dienstag, J. L., B. G. Werner, B. F. Polk, D. R. Snydman, D. E. Craven, R. Platt, C. S. Crumpacker, R. Ouellet-Hellstorm & G. F. Grady 1984. Hepatitis b vaccine in health care personnel: Safety, immunogenicity, and indicators of efficacy. Ann. Int. Med. 101(1): 34–40. 12 Fadda, G., A. Maida, C. Masia, G. Obino, G. Romano & E. Spano 1987. Efficacy of hepatitis b immunization with reduced intradermal doses. Eur. J. Epidemiol. 13(2): 176–180. 13 Foy, H. M., M. K. Cooney, J. Taylor, I. Allan, T-Y. Chuang, J. Blumhagen & J. P. Fox 1980. Antibody response to influenza A/New Jersey and A/Victoria virus vaccines in 1976 and subsequent antibody levels after influenza A epidemics, 1977–1979. J. Infect. Dis. 142(2): 139–144. 14 Hadler, S. C., D. P. Francis, J. E. Maynard, S. E. Thompson, F. N. Judson, D. F. Echenberg, D. G. Ostrow, P. M. O'Malley, K. A. Penley, N. L. Altman, E. Braff, G. F. Shipman, P. J. Coleman & E. J. Mandel 1986. Long-term immunogenicity and efficacy of hepatitis b vaccine in homosexual men. N. Engl. J. Med. 315(4): 210–214. 15 Käyhty, H., V. Karanko, H. Peltola, S. Sarna & P. H. Mäkelä. 1980. Scram antibodies to capsular polysaccharide vaccine of group A neisseria meningitidis followed for three years in infants and children. J. Infect. Dis. 142(6): 861–868. 16 Lau, J. Y. N., C. L. Lai, P. C. Wu & H. J. Lin 1989. Comparison of two plasma-derived hepatitis b vaccines: Long-term report of a prospective, randomized trial. J. Gastroenterol. Hepatol. 4: 331–337. 17 Overturf, G. D., J. G. Rigau-Perez, G. Honig, J. W. Seltzer, D. Powars, R. Steele, L. Chan, C. Uy, R. Edmonds, J. Weiss, E. J. Pang, B. Portnoy & R. Field 1982. Pneumococcal polysaccharide immunization of children with sickle cell disease. II. Serologic response and pneumococcal disease following immunization. Am. J. Pediatr. Hematol./Oncol. 4(1): 25–35. 18 Papaevangelou, G. J., C. G. Vissoulis, A. J. Roumeliotou-Karayannis, N. Kolaitis & S. Krugman 1982. Comparison of safety and immunogenicity of ADW and AYW hepatitis b vaccines. J. Med. Virol. 9: 231–236. 19 Pongpipat, D., V. Suvatte, A. Assateerawatts & S. Bhethraratt 1987. Active prexposure immunization against hepatitis b virus: Immunogenicity of hepatitis b vaccine in healthy Thai adults and children. Asian Pac. J. Allergy Immunol. 5: 63–65. 20 Tsega, E., B. Tafesse, E. Nordenfelt, G. Wolde-Hawariat, B-G. Hansson & J. Lindberg 1990. Immunogenicity of hepatitis b vaccine simultaneously with the expanded programme on immunization (EPI). J. Med. Virol. 32(43): 232–235. 21 Adlard, P. & K. Bryett 1987. Influenza immunization in children with cystic fibrosis. J. Int. Med. Res. 15: 344–351. 22 Ammann, A. J., G. Schiffman, J. E. Addiego, W. M. Wara & D. W. Wara 1981. Immunization of immunosuppressed patients with pneumococcal polysaccharide vaccine. Rev. Infect. Dis. 3(Suppl.): S160–S167. 23 Letson, G. W., M. Santosham, R. Reid, C. Priehs, B. Burns, A. Jahnke, S. Gahagan, L. Nienstadt, C. Johnson, D. Smith & G. Siber 1988. Comparison of active and combined passive/active immunization of Navajo children against haemophilus influenzae type b. Pediatr. Infect. Dis. J. 7(11): 747–752. 24 Zahradnik, J. M., R. B. Couch & J. L. Gerin 1987. Safety and immunogenicity of a purified hepatitis b virus vaccine prepared by using recombinant DNA technology. J. Infect. Dis. 155(5): 903–908. 25 Cochran, W. G. 1954. Some methods of strengthening the common X2 tests. Biometrics 10: 417–451. 26 Hosmer, D. W. & S. Lemeshow 1989. Applied Logistic Regression. John Wiley. New York , NY . 27 Fujiyama, S., K. Yoshida, T. Sato, H. Shimada & T. Deguchi 1990. Immunogenicity and safety of recombinant yeast-derived hepatitis b vaccine in haemodialysis patients. Hepato-Gastroenterol. 37(Suppl. II): 140–144. 28 Cox, D. R. 1972. Regression models and life tables. J. R. Stat. Soc. Series B34: 187–220. 29 Cox, D. R. & D. Oakes 1984. Analysis of Survival Data. Chapman and Hall. New York , NY . 30 Elandt-Johnson, R. C. & N. L. Johnson 1980. Survival Models and Data Analysis. John Wiley. New York , NY . 31 Kalbfleisch, J. D. & R. L. Prentice 1980. The Statistical Analysis of Failure Time Data. John Wiley. New York , NY . 32 Lee, E. T. 1992. Statistical Methods for Survival Data Analysis. 2nd ed. John Wiley. New York , NY . 33 Tibshirani, R. 1982. A plain man's guide to the proportional hazards model. Clin. Invest. Med. 5(1): 63–68. 34 Klecka, W. R. 1980. Discriminant Analysis. Sage Publications. Beverly Hills , CA . 35 Lachenbruch, P. A. 1975. Discriminant Analysis. Hafner. New York , NY . 36 Radhakrishna, S. 1964. Discrimination analysis in medicine. Statistician 14: 147–167. 37 Kunz, C., F. X. Heinz & H. Hofmann 1980. Immunogenicity and reactogenicity of a highly purified vaccine against tick-borne encephalitis. J. Med. Virol. 6: 103–109. 38 Bradley, J. V. 1968. Distribution-Free Statistical Tests. Prentice-Hall. Englewood Cliffs , NJ . 39 Conover, W. J. 1980. Prectical Nonparametric Statistics. 2nd ed. John Wiley. New York , NY . 40 Daniel, W. W. 1990. Applied Nonparametric Statistics. 2nd ed. PWS-KENT. Boston , MA . 41 Sprent, P. 1990. Applied Nonparametric Statistical Methods. Chapman and Hall. New York , NY . 42 Bernard, K. W., D. B. Fishbein, K. D. Miller, R. A. Parker, S. Waterman, J. W. Sumner, F. L. Reid, B. K. Johnson, A. J. Rollins, C. N. Oster, L. B. Schonberger, G. M. Baer & W. G. Winkler 1995. Pre-exposure rabies immunization with human diploid cell vaccine: Decreased antibody responses in persons immunized in developing countries. Am. J. Trop. Med. Hyg. 34(3): 633–647. 43 Zahorska, R., N. Mazur & M. Korbecki 1978. Immunogenicity of UV-inactivated measles virus immunogenität von UV-inaktiviertem masernvirus. Zbl. Bakt. Hyg., I. Abt. Orig. A 240: 424–430. 44 Krämer, A., D. Sommer, E. G. Hahn & E. O. Riecken 1986. German experimental hepatitis b vaccine-influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers. Klin. Wochenschr. 64(15) 688–694. 45 Nyerges, G. & M. Csukås. 1972. Immunogenicity of smallpox vaccines prepared from strains of different reactogenicity. Acta. Microbiol. Acad. Sci. Hung. 19: 103–109. 46 Brown, J., D. W. Dreesen, J. S. Smith & J. W. Sumner 1984. A proposed index system for reporting rabies rapid fluorescent focus inhibition test titres. J. Biol. Stand. 12: 233–240. 47 Katzenstein, D. A., L. K. Vujcic, A. Latif, R. Boulos, N. A. Halsey, T. C. Quinn, S. C. Rastogi & G. V. Quinnan 1990. Human immunodeficiency virus neutralizing antibodies in sera from North Americans and Africans. J. Acquired Immune Defic. Syndr. 3(8): 810–816. 48 Meadors, G. F., P. H. Gibbs & C. J. Peters 1986. Evaluation of a new rift valley fever vaccine: Safety and immunogenicity trials. Vaccine 4: 179–184. 49 Santosham, M., J. Hill, M. Wolff, R. Reid, L. Lukacs & V. Ahonkhai 1991. Safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine in a high risk American Indian population. Pediatr. Infect. Dis. J. 10(2): 113–117. 50 Siber, G. R., P. H. Schur, A. C. Aisenberg, S. A. Weitzman & G. Schiffman 1980. Correlation between serum IgG-2 concentrations and the antibody response to bacterial polysaccharide antigens. N. Engl. J. Med. 303(4): 177–182. 51 Crowder, M. J. & D. J. Hand 1990. Analysis of Repeated Measures. Chapman and Hall. New York , NY . 52 Michel, F. B., L. D. D'Hinterland, A. M. Pinel, R. Guendon, A. J. Guerrero, M. Moutou & J. P. Bansard 1980. Prevention of bacterial respiratory infection by an association of bacterial ribosomes and membranous proteoglycans. 2. Objective assessment of the response and of the immunological simulation. Arzneim. Forsch./Drug Res. 30(1): 198–206. 53 Gorsuch, R. L. 1983. Factor Analysis. Lawrence Erlbaum. Hillsdale , NJ . 54 Harmon, H. H. 1983. Modern Factor Analysis. 4th ed. University of Chicago Press. Chicago , IL . 55 Lawley, D. N. & A. E. Maxwell 1963. Factor Analysis as a Statistical Method. Butterworth. London . 56 Press, J. & S. Wilson. 1978. Choosing between logistic regression and discriminant analysis. J. Am. Stat. Assoc. 73(364): 699–705. 57 Chan, L. S., G. D. Overturf & J. Selzer 1983. Analyzing antibody response based on data obtained from serial dilution methods. Stat. Med. 2: 447–454. 58 Fleiss, J. L. 1986. The Design and Analysis of Clinical Experiments. John Wiley. New York , NY . 59 Schmid, G. P., R. P. Smith, A. L. Baltch, C. A. HALL & G. Schiffman 1981. Antibody response to pneumococcal vaccine in patients with multiple myeloma. J. Infect. Dis. 143(4): 590–597. 60 Blackwelder, W. C. 1995. Similarity/equivalence trials for combination vaccines. Ann. N.Y. Acad. Sci. This volume. Citing Literature Volume754, Issue1Combined Vaccines and Simultaneous Administration: Current Issues and PerspectivesMay 1995Pages 329-346 ReferencesRelatedInformation