Siegrist CA, Plotkin SA, Orenstein W: The immunology of vaccintion. Vaccines. 2008, Offit PA: Elsevier, 17-36. 5
Google Scholar
Advisory Committee for Immunization Practices (ACIP): ACIP Recommendations. http://www.cdc.gov/vaccines/pubs/ACIP-list.htm,
World Health Organization, Department of Immunization, Vaccines and Biologicals: Immunological basis for immunization series. http://www.who.int/immunization/documents/immunological_basis_series/en]
Plotkin SA: Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010, 17 (7): 1055-1065. 10.1128/CVI.00131-10.
Article
CAS
PubMed
PubMed Central
Google Scholar
Baylor N: Regulatory perspective: issues of correlates versus surrogates and implications for licensure. 2009, Bamako, Mali: WHO Global Vaccine Research Forum conference workshop on correlates of protection relevant to the African context, http://www.who.int/vaccine_research/documents/WCP_Baylor_presentation.pdf,
Google Scholar
Grand Challenges in Global Health. http://www.grandchallenges.org/NewVaccines/Challenges/LearnaboutImmunologicalResponses/Pages/default.aspx,
Qin L, Gilbert PB, Corey L, McElrath MJ, Self SG: A framework for assessing immunological correlates of protection in vaccine trials. J Infect Dis. 2007, 196 (9): 1304-1312. 10.1086/522428.
Article
PubMed
Google Scholar
Gilbert PB, Qin L, Self SG: Evaluating a surrogate endpoint at three levels, with application to vaccine development. Stat Med. 2007, 27: 4758-4778.
Article
Google Scholar
Plotkin SA, Gilbert PG: Nomenclature for immune correlates of protection after vaccination. Clin Infect Dis. 2012, 54 (11): 1615-1617. 10.1093/cid/cis238.
Article
PubMed
PubMed Central
Google Scholar
Dunning A: Experimental designs and statistical methods for post-licensure immunological correlates of protection. 2011, Washington DC: ASA Biopharmaceutical Section FDA-Industry Statistics Workshop, http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=AbstractDetails&AbstractID=301569,
Google Scholar
Chan I: Assessing the predictive value of immunological markers in vaccines. 2011, Washington DC: ASA Biopharmaceutical Section FDA-Industry Statistics Workshop, http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=AbstractDetails&AbstractID=301590,
Google Scholar
Björkholm B, Böttiger M, Christenson B, Hagberg L: Antitoxin antibody levels and the outcome of illness during an outbreak of diphtheria among alcoholics. Scand J Infect Dis. 1986, 18 (3): 235-239. 10.3109/00365548609032332.
Article
PubMed
Google Scholar
World Health Organization, Department of Immunization, Vaccines and Biologicals: Immunological basis for immunization series. Module 2: Diptheria Update. 2009, http://whqlibdoc.who.int/publications/2009/9789241597869_eng.pdf,
Google Scholar
Chen RT, Markowitz LE, Albrecht P, Stewart JA, Mofenson LM, Preblud SR, Orenstein WA: Measles antibody: reevaluation of protective titers. J Infect Dis. 1990, 162 (5): 1036-1042. 10.1093/infdis/162.5.1036.
Article
CAS
PubMed
Google Scholar
Neumann PW, Weber JM, Jessamine AG, O’Shaughnessy MV: Comparison of measles antihemolysin test, enzyme-linked immunosorbent assay, and hemagglutination inhibition test with neutralization test for determination of immune status. J Clin Microbiol. 1985, 22 (2): 296-298.
CAS
PubMed
PubMed Central
Google Scholar
Goldschneider I, Gotschlich EC, Artenstein MS: Human immunity to the meningococcus. II. Development of natural immunity. J Exp Med. 1969, 129 (6): 1327-1348.
CAS
PubMed
Google Scholar
White CJ, Kuter BJ, Ngai A, Hildebrand CS, Isganitis KL, Patterson CM, Capra A, Miller WJ, Krah DL, Provost PJ, Ellis RW, Calandra GB: Modified cases of chickenpox after varicella vaccination: correlation of protection with antibody response. Pediatr Infect Dis J. 1992, 11: 19-23. 10.1097/00006454-199201000-00006.
Article
CAS
PubMed
Google Scholar
Siber GR: Methods for estimating serological correlates of protection. Dev Biol Stand. 1997, 89: 283-296.
CAS
PubMed
Google Scholar
Jódar L, Butler J, Carlone G, Dagan R, Goldblatt D, Käyhty H, Klugman K, Plikaytis B, Siber G, Kohberger R, Chang I, Cherian T: Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants. Vaccine. 2003, 21 (23): 3265-3272. 10.1016/S0264-410X(03)00230-5.
Article
PubMed
Google Scholar
Siber GR, Chang I, Baker S, Fernsten P, O’Brien KL, Santosham M, Klugman KP, Madhi SA, Paradiso P, Kohberger R: Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine. 2007, 25: 3816-3826. 10.1016/j.vaccine.2007.01.119.
Article
CAS
PubMed
Google Scholar
Advisory Committee on Immunization Practices: Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children. MMWR Morb Mortal Wkly Rep. 2010, 59 (9): 258-261.
Google Scholar
Andrews N, Borrow R, Miller E: Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin Diagn Lab Immunol. 2003, 10 (5): 780-786.
PubMed
PubMed Central
Google Scholar
Cherry JD, Gornbein J, Heininger U, Stehr K: A search for serologic correlates of immunity to Bordetella pertussis cough illnesses. Vaccine. 1998, 16 (20): 1901-1906. 10.1016/S0264-410X(98)00226-6.
Article
CAS
PubMed
Google Scholar
Dagan R, Givon-Lavi N, Fraser D, Lipsitch M, Siber GR, Kohberger R: Serum serotype-specific pneumococcal anticapsular immunoglobulin g concentrations after immunization with a 9-valent conjugate pneumococcal vaccine correlate with nasopharyngeal acquisition of pneumococcus. J Infect Dis. 2005, 192 (3): 367-376. 10.1086/431679.
Article
CAS
PubMed
Google Scholar
Gustafsson L, Hallander HO, Olin P, Reizenstein E, Storsaeter J: A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N Engl J Med. 1996, 334 (6): 349-355. 10.1056/NEJM199602083340602.
Article
CAS
PubMed
Google Scholar
Piedra PA, Jewell AM, Cron SG, Atmar RL, Glezen WP: Correlates of immunity to respiratory syncytial virus (RSV) associated-hospitalization: establishment of minimum protective threshold levels of serum neutralizing antibodies. Vaccine. 2003, 21 (24): 3479-3482. 10.1016/S0264-410X(03)00355-4.
Article
PubMed
Google Scholar
Stehr K, Cherry JD, Heininger U, Schmitt-Grohé S, Überall M, Laussucq S, Eckhardt T, Meyer M, Engelhardt R, Christenson P, the Pertussis Vaccine Study Group: A comparative efficacy trial in Germany in infants who received either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP vaccine, or DT vaccine. Pediatrics. 1998, 101 (1): 1-11. 10.1542/peds.101.1.1.
Article
CAS
PubMed
Google Scholar
Storsaeter J, Hallander HO, Gustafsson L, Olin P: Levels of anti-pertussis antibodies related to protection after household exposure to Bordetella pertussis. Vaccine. 1998, 16: 1907-1916. 10.1016/S0264-410X(98)00227-8.
Article
CAS
PubMed
Google Scholar
Rapola S, Jantti V, Eerola M, Makela PH, Kayhty H, Kilpi T: Anti-PsaA and the risk of pneumococcal AOM and carriage. Vaccine. 2003, 21: 3608-3613. 10.1016/S0264-410X(03)00409-2.
Article
CAS
PubMed
Google Scholar
Jokinen JT, Ahman H, Kilpi TM, Mäkelä PH, Käyhty H: Concentration of antipneumococcal antibodies as a serological correlate of protection: An application to acute otitis media. J Infect Dis. 2004, 190: 545-550. 10.1086/422531.
Article
CAS
PubMed
Google Scholar
Chan I, Li S, Matthews H, Chan C, Vessey R, Sadoff J, Heyse J: Use of statistical models for evaluating antibody response as a correlate of protection against varicella. Stat Med. 2002, 21 (22): 3411-3430. 10.1002/sim.1268.
Article
PubMed
Google Scholar
Dunning AJ: A model for immunological correlates of protection. Stat Med. 2006, 25: 1485-1497. 10.1002/sim.2282.
Article
PubMed
Google Scholar
Coudeville L, Bailleux F, Riche B, Megas F, André P, Ecochard R: Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a bayesian random-effects model. BMC Med Res Methodol. 2010, 10 (1): 18-10.1186/1471-2288-10-18.
Article
PubMed
PubMed Central
Google Scholar
Forrest BD, Pride MW, Dunning AJ, Capeding MR, Chotpitayasunondh T, Tam JS, Rappaport R, Eldridge JH, Gruber WC: Correlation of cellular immune responses with protection against culture-confirmed influenza virus in young children. Clin Vaccine Immunol. 2008, 15 (7): 1042-1053. 10.1128/CVI.00397-07.
Article
CAS
PubMed
PubMed Central
Google Scholar
Black S, Nicolay U, Vesikari T, Knuf M, Del Giudice G, Della Cioppa G, Tsai T, Clemens R, Rappuoli R: Hemagglutination inhibition antibody titers as a correlate of protection for inactivated influenza vaccines in children. Pediatr Infect Dis J. 2011, 30 (12): 1081-1085. 10.1097/INF.0b013e3182367662.
Article
PubMed
Google Scholar
Miller R, Siegmund D: Maximally selected chi square statistics. Biometrics. 1982, 38: 1011-1016. 10.2307/2529881.
Article
Google Scholar
Efron B, Tibshirani R: An Introduction to the Bootstrap. Boca Raton. 1994, : Chapman & Hall/CRC Press LLC
Google Scholar
Hosmer DW, Lemeshow S, Klar J: Goodness-of-fit testing for the multiple logistic regression when the estimated probabilities are small. Biom J. 1988, 30: 911-924. 10.1002/bimj.4710300805.
Article
Google Scholar
Gershon AA, Takahashi M, Seward J: Varicella Vaccine. Vaccines. Edited by: Plotkin SA, Orenstein W. 2008, Offit PA: Elsevier, 915-958. 5
Google Scholar
Goldblatt D: Immunological perspective on correlates for bacterial polysaccharide vaccines: responses, memory and assays. 2009, Bamako, Mali: WHO Global Vaccine Research Forum conference workshop on correlates of protection relevant to the African context, http://www.who.int/vaccine_research/documents/WCP_Goldblatt_presentation.pdf,
Google Scholar
Follmann D: Augmented designs to assess immune response in vaccine trials. Biometrics. 2006, 62 (4): 1161-1169. 10.1111/j.1541-0420.2006.00569.x.
Article
PubMed
PubMed Central
Google Scholar
Wolfson J, Peter Gilbert PB: Statistical identifiability and the surrogate endpoint problem. Biometrics. 2010, 66: 1153-1161. 10.1111/j.1541-0420.2009.01380.x.
Article
PubMed
PubMed Central
Google Scholar
Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, Elvin L, Ensor KM, Hackell J, Siber G, Malinoski F, Madore D, Chang I, Kohberger R, Watson W, Austrian R, Edwards K: Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000, 19 (3): 187-195. 10.1097/00006454-200003000-00003.
Article
CAS
PubMed
Google Scholar
Frey S, Vesikari T, Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Groth N, Holmes S: Clinical efficacy of cell culture-derived and egg-derived inactivated subunit influenza vaccines in healthy adults. Clin Infect Dis. 2010, 51 (9): 997-1004. 10.1086/656578.
Article
PubMed
Google Scholar
Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR: Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006, 354 (1): 11-22. 10.1056/NEJMoa052434.
Article
CAS
PubMed
Google Scholar