Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine

References

• Tate JE , Burton AH , Boschi-Pinto C , Parashar UD , World Health Organization–Coordinated Global Rotavirus Surveillance Network . Global, regional, and national estimates of rotavirus mortality in children <5 years of age, 2000–2013. Clin Infect Dis. 2016;62(Suppl 2):S96-S105. doi:10.1093/cid/civ1013. PMID:27059362
   PubMed Web of Science ®Google Scholar
• Staat MA , Azimi PH , Berke T , Roberts N , Bernstein DI , Ward RL , Pickering LK , Matson DO. Clinical presentations of rotavirus infection among hospitalized children. Pediatr Infect Dis J. 2002;21:221-7. doi:10.1097/00006454-200203000-00012. PMID:12005086
   PubMed Web of Science ®Google Scholar
• Parashar UD , Burton A , Lanata C , Boschi-Pinto C , Shibuya K , Steele D , Birmingham M , Glass RI . Global mortality associated with rotavirus disease among children in 2004. J Infect Dis. 2009;200(Suppl 1):S9-S15. doi:10.1086/605025. PMID:19817620
   PubMed Web of Science ®Google Scholar
• Tate JE , Patel MM , Steele AD , Gentsch JR , Payne DC , Cortese MM , Nakagomi O , Cunliffe NA , Jiang B , Neuzil KM , et al. Global impact of rotavirus vaccines. Expert Rev Vaccines. 2010;9(4):395-407. doi:10.1586/erv.10.17. PMID:20370550
   PubMed Web of Science ®Google Scholar
• Kapikian AZ , et al. Rotavirus. In: Kripe DM , editor(s). Fields virology. Vol 2. 4th ed. Lippincott Williams & Wilkins; 2001. p. 1787-825.
   Google Scholar
• Franco MA , Angel J , Greenberg HB . Immunity and correlates of protection for rotavirus vaccines. Vaccine. 2006;24(15):2718-31. doi:10.1016/j.vaccine.2005.12.048. PMID:16446014
   PubMed Web of Science ®Google Scholar
• Desselberger U , Huppertz H . Immune responses to rotavirus infection and vaccination and associated correlates of protection. JID. 2011;203:188-94. doi:10.1093/infdis/jiq031. PMID:21288818
   PubMed Web of Science ®Google Scholar
• Angel J , Franco MA , Greenberg HB . Rotavirus immune responses and correlates of protection. Curr Opin Virol. 2012;2(4):419-25. doi:10.1016/j.coviro.2012.05.003. PMID:22677178
   PubMed Web of Science ®Google Scholar
• Angel J , Steele AD , Franco MA . Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges. Hum Vaccin Immunother. 2014;10:3659-71. doi:10.4161/hv.34361. PMID:25483685
   PubMed Web of Science ®Google Scholar
• Velázquez FR , Matson DO , Guerrero ML , Shults J , Calva JJ , Morrow AL , Glass RI , Pickering LK , Ruiz-Palacios GM . Serum antibody as a marker of protection against natural rotavirus infection and disease. J Infect Dis. 2000;182(6):1602-9. doi:10.1086/317619. PMID:11069230
   PubMed Web of Science ®Google Scholar
• Hjelt K , Grauballe PC , Paerregaard A , Nielsen OH , Krasilnikoff PA . Protective effect of preexisting rotavirus-specific immunoglobulin A against naturally acquired rotavirus infection in children. J Med Virol. 1987;21(1):39-47. doi:10.1002/jmv.1890210106. PMID:3025356
   PubMed Web of Science ®Google Scholar
• Ciarlet M1 , Schödel F . Development of a rotavirus vaccine: Clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, PRV. Vaccine. 2009;27(Suppl 6):G72-81. doi:10.1016/j.vaccine.2009.09.107. PMID:20006144
   PubMed Web of Science ®Google Scholar
• Ward RL , Bernstein DI . Lack of correlation between serum rotavirus antibody titers and protection following vaccination with reassortant RRV vaccines. US Rotavirus Vaccine Efficacy Group. Vaccine. 1995;13(13):1226-32. doi:10.1016/0264-410X(95)00060-E. PMID:8578808
   PubMed Web of Science ®Google Scholar
• Ward RL , Knowlton DR , Zito ET , Davidson BL , Rappaport R , Mack ME . Serologic correlates of immunity in a tetravalent reassortant rotavirus vaccine trial. US Rotavirus Vaccine Efficacy Group. J Infect Dis. 1997;176(3):570-7. doi:10.1086/514076. PMID:9291301
   PubMed Web of Science ®Google Scholar
• Patel M , Glass RI , Jiang B , Santosham M , Lopman B , Parashar U . A systematic review of anti-rotavirus serum IgA antibody titer as a potential correlate of rotavirus vaccine efficacy. J Infect Dis. 2013;208(2):284-94. doi:10.1093/infdis/jit166. PMID:23596320
   PubMed Web of Science ®Google Scholar
• Cheuvart B , Neuzil K , Steele A , Cunliffe N , Madhi S , Karkada N , Han H , Vinals C . Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis. Hum Vaccin Immunother. 2014;10:505-11. doi:10.4161/hv.27097. PMID:24240068
   PubMed Web of Science ®Google Scholar
• Ciarlet M , Sani-Grosso R , Yuan G , Liu G , Heaton P , Gottesdiener K , Arredondo J , Schodel F . Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008;27:874-80. doi:10.1097/INF.0b013e3181782780. PMID:18756184
   PubMed Web of Science ®Google Scholar
• Plotkin SA , Gilbert PB . Nomenclature for immune correlates of protection after vaccination. Clin Infect Dis. 2012;54:1615-7. doi:10.1093/cid/cis238. PMID:22437237
   PubMed Web of Science ®Google Scholar
• Lappalainen S , Blazevic V , Malm M , Vesikari T . Rotavirus vaccination and infection induce VP6-specific IgA responses. J Med Virol. 2017;89:239-45. doi:10.1002/jmv.24636. PMID:27431308
   PubMed Web of Science ®Google Scholar
• Gabriel EE , Daniels MJ , Halloran ME . Comparing biomarkers as trial level general surrogates. Biometrics. 2016;72:1046-54. doi:10.1111/biom.12513. PMID:27038302
   PubMed Web of Science ®Google Scholar
• Gruber JF , Hille DA , Liu GF , Kaplan SS , Nelson M , Goveia MG , Mast TC . Heterogeneity of rotavirus vaccine efficacy among infants in developing countries. Pediatr Infect Dis J. 2016;36:72-78. https://doi.org/10.1097/INF.0000000000001362
   Web of Science ®Google Scholar
• Knowlton DR , Spector DM , Ward RL . Development of an improved method for measuring neutralizating antibody for rotavirus. J Virol Methods. 1991;33:127-34. doi:10.1016/0166-0934(91)90013-P. PMID:1658027
   PubMed Web of Science ®Google Scholar
• Ward RL , Kapikian AZ , Goldberg KM , Knowlton DR , Watson MW , Rappaport R . Serum rotavirus neutralizing-antibody titers compared by plaque reduction and enzyme-linked immunosorbent assay-based neutralization assays. J Clin Microbiol. 1996;34:983-5. doi:10.1093/infdis/159.1.79. PMID:8815124
   PubMed Web of Science ®Google Scholar
• Ward RL , Bernstein DI , Shukla R , Young EC , Sherwood JR , McNeal MM , Walker MC , Schiff GM . Effects of antibody to rotavirus on protection of adults challenged with a human rotavirus. J Infect Dis. 1989;159:79-88. PMID:2535868
   PubMed Web of Science ®Google Scholar
• 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;196:1304-12. doi:10.1086/522428. PMID:17922394
   PubMed Web of Science ®Google Scholar
• Vesikari T , Clark HF , Offit PA , Dallas MJ , DiStefano DJ , Goveia MG , Ward RL , Schödel F , Karvonen A , Drummond JE , et al. Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine. 2006;24(22):4821-9. doi:10.1016/j.vaccine.2006.03.025. PMID:16621194
   PubMed Web of Science ®Google Scholar
• Vesikari T1 , Matson DO , Dennehy P , Van Damme P , Santosham M , Rodriguez Z , Dallas MJ , Heyse JF , Goveia MG , Black SB , et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23-33. doi:10.1056/NEJMoa052664. PMID:16394299
   PubMed Web of Science ®Google Scholar
• Block SL1 , Vesikari T , Goveia MG , Rivers SB , Adeyi BA , Dallas MJ , Bauder J , Boslego JW , Heaton PM , Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group . Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007;119(1):11-8. doi:10.1542/peds.2006-2058. PMID:17200266
   PubMed Web of Science ®Google Scholar
• Armah GE , Sow SO , Breiman RF , Dallas MJ , Tapia MD , Feikin DR , Binka FN , Steele AD , Laserson KF , Ansah NA , et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: A randomised, double-blind, placebo-controlled trial. Lancet. 2010;376(9741):606-14. doi:10.1016/S0140-6736(10)60889-6. PMID:20692030
   PubMed Web of Science ®Google Scholar
• Zaman K , Dang DA , Victor JC , Shin S , Yunus M , Dallas MJ , Podder G , Vu DT , Le TP , Luby SP , et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: A randomised, double-blind, placebo-controlled trial. Lancet. 2010;376(9741):615-23. doi:10.1016/S0140-6736(10)60755-6. PMID:20692031
   PubMed Web of Science ®Google Scholar
• Mo Z , Mo Y , Li M , Tao J , Yang X , Diao D , Wei D , Fu B , Liao X , Chu J , et al. Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in health Chinese infants: A randomized, double-blind, placebo-controlled trial. In: Program and Abstracts of the 12th International Rotavirus Symposium; 2016 Sep 7–9 ; Melbourne, Australia ; Abstract 42
   Google Scholar
• Liao X , Mo Z , Ma X , Luo P , Mo Y , Kaplan S , Shou A , Zheng M , Hille D , Nelson M , et al. Immunogenicity of pentavalent rotavirus vaccine in Chinese infants: A randomized, double-blind, placebo-controlled trial. In: Program and Abstracts of 8th Asian Congress of Pediatric Infectious Diseases; 2016 Nov 7–10 ; Bangkok, Thailand ; Abstract EP-079
   Google Scholar