Tandem truncated rotavirus VP8* subunit protein with T cell epitope as non-replicating parenteral vaccine is highly immunogenic

References

• Tate JE, Burton AH, Boschi-Pinto C, Steele AD, Duque J, Parashar UD. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12:136-41; PMID:22030330; http://dx.doi.org/10.1016/S1473-3099(11)70253-5
   PubMed Web of Science ®Google Scholar
• World Health Organization. Meeting of the immunization Strategic Advisory Group of Experts, April 2009-conclusions and recommendations. Wkly Epidemiol Rec 2009; 84:220-36; PMID:19499606; Available at http://www.who.int/wer/2009/wer8423.pdf
   PubMedGoogle Scholar
• World Health Organization. Meeting of the Strategic Advisory Group of Experts on immunization, October 2009-conclusions and recommendations. 2009; 84:517-32; PMID:19999831; Available at http://www.who.int/wer/2009/wer8450.pdf
   PubMedGoogle Scholar
• World Health Organization. Rotavirus vaccines. WHO position paper-January 2013. Wkly Epidemiol Rec 2013; 84:49-64; PMID:23424730; Available at http://www.who.int/wer/2013/wer8805.pdf
   PubMedGoogle Scholar
• Rota Council [Internet]. National and Regional Rotavirus Vaccine Introductions. Availabe from http://rotacouncil.org/national-and-regional-rotavirus-introductions/. Last accessed 04.05.2015
   Google Scholar
• McCormack PL, Keam SJ. Rotavirus vaccine RIX4414 (Rotarix): a review of its use in the prevention of rotavirus gastroenteritis. Paediatr Drugs 2009; 11:75-88; PMID:19127963; http://dx.doi.org/10.2165/0148581-200911010-00025
   PubMedGoogle Scholar
• Chandran A, Santosham M. RotaTeq: a three-dose oral pentavalent reassortant rotavirus vaccine. Expert Rev Vaccines 2008; 7:1475-80; PMID:19053204; http://dx.doi.org/10.1586/14760584.7.10.1475
   PubMed Web of Science ®Google Scholar
• Soares-Weiser K, Maclehose H, Bergman H, Ben-Aharon I, Nagpal S, Goldberg E, Pitan F, Cunliffe N. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev 2012; 11:CD008521
   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; 376:606-14; PMID:20692030; http://dx.doi.org/10.1016/S0140-6736(10)60889-6
   PubMed Web of Science ®Google Scholar
• Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, Ngwira B, Victor JC, Gillard PH, Cheuvart BB, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med 2010; 362:289-98; PMID:20107214; http://dx.doi.org/10.1056/NEJMoa0904797
   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; 376:615-23; PMID:20692031; http://dx.doi.org/10.1016/S0140-6736(10)60755-6
   PubMed Web of Science ®Google Scholar
• Jiang V, Jiang B, Tate J, Parashar UD, Patel MM. Performance of rotavirus vaccines in developed and developing countries. Hum Vaccin 2010; 6:532-42; PMID:20622508; http://dx.doi.org/10.4161/hv.6.7.11278
   PubMed Web of Science ®Google Scholar
• Chandran A, Fitzwater S, Zhen A, Santosham M. Prevention of rotavirus gastroenteritis in infants and children: rotavirus vaccine safety, efficacy, and potential impact of vaccines. Biologics 2010; 4:213-29; PMID:20714358
   PubMedGoogle Scholar
• Payne DC, Edwards KM, Bowen MD, Keckley E, Peters J, Esona MD, Teel EN, Kent D, Parashar UD, Gentsch JR. Sibling transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus gastroenteritis. Pediatrics 2010; 125:e438-41; PMID:20100758; http://dx.doi.org/10.1542/peds.2009-1901
   PubMed Web of Science ®Google Scholar
• Bucardo F, Rippinger CM, Svensson L, Patton JT. Vaccine-derived NSP2 segment in rotaviruses from vaccinated children with gastroenteritis in Nicaragua. Infect Genet Evol 2012; 12:1282-94; PMID:22487061; http://dx.doi.org/10.1016/j.meegid.2012.03.007
   PubMed Web of Science ®Google Scholar
• Boom JA, Sahni LC, Payne DC, Gautam R, Lyde F, Mijatovic-Rustempasic S, Bowen MD, Tate JE, Rench MA, Gentsch JR, et al. Symptomatic infection and detection of vaccine and vaccine-reassortant rotavirus strains in 5 children: a case series. J Infect Dis 2012; 206:1275-9; PMID:22872730; http://dx.doi.org/10.1093/infdis/jis490
   PubMed Web of Science ®Google Scholar
• Hemming M, Vesikari T. Detection of rotateq vaccine-derived, double-reassortant rotavirus in a 7-year-old child with acute gastroenteritis. Pediatr Infect Dis J 2014; 33:655-6; PMID:24326415; http://dx.doi.org/10.1097/INF.0000000000000221
   PubMed Web of Science ®Google Scholar
• Wen X, Wen K, Cao D, Li G, Jones RW, Li J, Szu S, Hoshino Y, Yuan L. Inclusion of a universal tetanus toxoid CD4(+) T cell epitope P2 significantly enhanced the immunogenicity of recombinant rotavirus DeltaVP8* subunit parenteral vaccines. Vaccine 2014; 32:4420-7; PMID:24962749; http://dx.doi.org/10.1016/j.vaccine.2014.06.060
   PubMed Web of Science ®Google Scholar
• Victoria JG, Wang C, Jones MS, Jaing C, McLoughlin K, Gardner S, Delwart EL. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J Virol 2010; 84:6033-40; PMID:20375174; http://dx.doi.org/10.1128/JVI.02690-09
   PubMed Web of Science ®Google Scholar
• Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, Platt R, Selvam N, Selvan M, Lee GM, Nguyen M. Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med 2014; 370:503-12; PMID:24422676; http://dx.doi.org/10.1056/NEJMoa1303164
   PubMed Web of Science ®Google Scholar
• Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, Klein NP, Glanz JM, Jacobsen SJ, Naleway A, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med 2014; 370:513-9; PMID:24422678; http://dx.doi.org/10.1056/NEJMoa1311738
   PubMed Web of Science ®Google Scholar
• Rha B, Tate JE, Weintraub E, Haber P, Yen C, Patel M, Cortese MM, DeStefano F, Parashar UD. Intussusception following rotavirus vaccination: an updated review of the available evidence. Expert Rev Vaccines 2014; 13:1339-48; PMID:25066368; http://dx.doi.org/10.1586/14760584.2014.942223
   PubMed Web of Science ®Google Scholar
• PATH. Vaccines for the Future, News from PATH's Vaccine Development Program. Seattle, WA: PATH; 2012; April:2-3; Available at http://sites.path.org/vaccinedevelopment/diarrhea-rotavirus-shigella-etec/ Last accessed 07.02.2015.
   Google Scholar
• Cryz S, Hrro C, McNeal MM, Meyer N, DeNearing B, Cage A, Adams D, Flores J, Boslego JW, Fix A. Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults. Eleventh International Rotavirus Symposium. New Delhi, India, 2014; 80-1
   Google Scholar
• Offit PA, Clark HF. Maternal antibody-mediated protection against gastroenteritis due to rotavirus in newborn mice is dependent on both serotype and titer of antibody. J Infect Dis 1985; 152:1152-8; PMID:2999254; http://dx.doi.org/10.1093/infdis/152.6.1152
   PubMed Web of Science ®Google Scholar
• Westerman LE, McClure HM, Jiang B, Almond JW, Glass RI. Serum IgG mediates mucosal immunity against rotavirus infection. Proc Natl Acad Sci U S A 2005; 102:7268-73; PMID:15883382; http://dx.doi.org/10.1073/pnas.0502437102
   PubMed Web of Science ®Google Scholar
• Crawford SE, Estes MK, Ciarlet M, Barone C, O'Neal CM, Cohen J, Conner ME. Heterotypic protection and induction of a broad heterotypic neutralization response by rotavirus-like particles. J Virol 1999; 73:4813-22; PMID:10233942
   PubMed Web of Science ®Google Scholar
• Ciarlet M, Crawford SE, Barone C, Bertolotti-Ciarlet A, Ramig RF, Estes MK, Conner ME. Subunit rotavirus vaccine administered parenterally to rabbits induces active protective immunity. J Virol 1998; 72:9233-46; PMID:9765471
   PubMed Web of Science ®Google Scholar
• Wen X, Cao D, Jones RW, Li J, Szu S, Hoshino Y. Construction and characterization of human rotavirus recombinant VP8* subunit parenteral vaccine candidates. Vaccine 2012; 30:6121-6; PMID:22885016; http://dx.doi.org/10.1016/j.vaccine.2012.07.078
   PubMed Web of Science ®Google Scholar
• Brito LA, Singh M. Acceptable levels of endotoxin in vaccine formulations during preclinical research. J Pharm Sci 2011; 100:34-7; PMID:20575063; http://dx.doi.org/10.1002/jps.22267
   PubMed Web of Science ®Google Scholar
• Siemasko K, Skaggs BJ, Kabak S, Williamson E, Brown BK, Song W, Clark MR. Receptor-facilitated antigen presentation requires the recruitment of B cell linker protein to Igalpha. J Immunol 2002; 168:2127-38; PMID:11859098; http://dx.doi.org/10.4049/jimmunol.168.5.2127
   PubMed Web of Science ®Google Scholar
• Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J 2006; 8:E501-7; PMID:17025268; http://dx.doi.org/10.1208/aapsj080359
   PubMed Web of Science ®Google Scholar
• Partidos C, Stanley C, Steward M. The influence of orientation and number of copies of T and B cell epitopes on the specificity and affinity of antibodies induced by chimeric peptides. Eur J Immunol 1992; 22:2675-80; PMID:1382995; http://dx.doi.org/10.1002/eji.1830221030
   PubMed Web of Science ®Google Scholar
• Kovacs-Nolan J, Mine Y. Tandem copies of a human rotavirus VP8 epitope can induce specific neutralizing antibodies in BALB/c mice. Biochim Biophys Acta 2006; 1760:1884-93; PMID:16978788; http://dx.doi.org/10.1016/j.bbagen.2006.07.015
   PubMed Web of Science ®Google Scholar
• Patel NC, Hertel PM, Estes MK, de la Morena M, Petru AM, Noroski LM, Revell PA, Hanson IC, Paul ME, Rosenblatt HM, et al. Vaccine-acquired rotavirus in infants with severe combined immunodeficiency. N Engl J Med 2010; 362:314-9; PMID:20107217; http://dx.doi.org/10.1056/NEJMoa0904485
   PubMed Web of Science ®Google Scholar
• Uygungil B, Bleesing JJ, Risma KA, McNeal MM, Rothenberg ME. Persistent rotavirus vaccine shedding in a new case of severe combined immunodeficiency: A reason to screen. J Allergy Clin Immunol 2010; 125:270-1; PMID:20109754; http://dx.doi.org/10.1016/j.jaci.2009.10.029
   PubMed Web of Science ®Google Scholar
• Klinkenberg D, Blohm M, Hoehne M, Mas Marques A, Malecki M, Schildgen V, Schneppenheim R, Muller I, Schildgen O, Kobbe R. Risk of rotavirus vaccination for children with SCID. Pediatr Infect Dis J 2015; 34:114-5; PMID:25741807; http://dx.doi.org/10.1097/INF.0000000000000507
   PubMed Web of Science ®Google Scholar
• Ma Y, Qin M, Hu HQ, Ji G, Feng L, Gao N, Gu J, Xie BF, He JH, Sun MB. [Immunogenicity of sabin inactivated poliovirus vaccine induced by diphtheria-tetanus-acellular pertussis and Sabin inactivated poliovirus combined vaccine]. Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi 2011; 25:197-200; PMID:21977591
   PubMedGoogle Scholar
• Lee SY, Hwang HS, Kim JH, Kim HH, Lee HS, Chung EH, Park SE, Ma SH, Chang JK, Guitton F, et al. Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea. Vaccine 2011; 29:1551-7; PMID:21215828; http://dx.doi.org/10.1016/j.vaccine.2010.12.094
   PubMed Web of Science ®Google Scholar
• Kouiavskaia D, Collett MS, Dragunsky EM, Sarafanov A, Chumakov KM. Immunogenicity of inactivated polio vaccine with concurrent antiviral V-073 administration in mice. Clin Vaccine Immunol 2011; 18:1387-90; PMID:21715577; http://dx.doi.org/10.1128/CVI.05147-11
   PubMed Web of Science ®Google Scholar
• Frampton JE. DTaP(5)-IPV-Hib Vaccine (Pediacel(R)). Paediatr Drugs 2011; 13:401-15; PMID:21999652; http://dx.doi.org/10.2165/11207740-000000000-00000
   PubMedGoogle Scholar
• Hewlett AT. Combined hepatitis A and B vaccine: providing a bright future for preventing hepatitis. Expert Opin Biol Ther 2009; 9:1235-40; PMID:19601727; http://dx.doi.org/10.1517/14712590903160639
   PubMed Web of Science ®Google Scholar
• Santos N, Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol 2005; 15:29-56; PMID:15484186; http://dx.doi.org/10.1002/rmv.448
   PubMed Web of Science ®Google Scholar
• Iturriza-Gomara M, Dallman T, Banyai K, Bottiger B, Buesa J, Diedrich S, Fiore L, Johansen K, Koopmans M, Korsun N, et al. Rotavirus genotypes co-circulating in Europe between 2006 and 2009 as determined by EuroRotaNet, a pan-European collaborative strain surveillance network. Epidemiol Infect 2011; 139:895-909; PMID:20707941; http://dx.doi.org/10.1017/S0950268810001810
   PubMed Web of Science ®Google Scholar
• Matthijnssens J, Rahman M, Van Ranst M. Two out of the 11 genes of an unusual human G6P[6]rotavirus isolate are of bovine origin. J Gen Virol 2008; 89:2630-5; PMID:18796733; http://dx.doi.org/10.1099/vir.0.2008/003780-0
   PubMed Web of Science ®Google Scholar
• Sanz JC, Barbas JF, Lasheras MD, Jimenez M, Ramos B, Sanchez-Fauquier A. [Detection of a rotavirus G9P[8]outbreak causing gastroenteritis in a geriatric nursing home]. Enferm Infecc Microbiol Clin 2009; 27:219-21; PMID:19249129; http://dx.doi.org/10.1016/j.eimc.2008.06.005
   PubMed Web of Science ®Google Scholar
• Mukherjee A, Dutta D, Ghosh S, Bagchi P, Chattopadhyay S, Nagashima S, Kobayashi N, Dutta P, Krishnan T, Naik TN, et al. Full genomic analysis of a human group A rotavirus G9P[6]strain from Eastern India provides evidence for porcine-to-human interspecies transmission. Arch Virol 2009; 154:733-46; PMID:19333549; http://dx.doi.org/10.1007/s00705-009-0363-3
   PubMed Web of Science ®Google Scholar
• Cunliffe NA, Ngwira BM, Dove W, Nakagomi O, Nakagomi T, Perez A, Hart CA, Kazembe PN, Mwansambo CC. Serotype g12 rotaviruses, Lilongwe, Malawi. Emerg Infect Dis 2009; 15:87-90; PMID:19116060; http://dx.doi.org/10.3201/eid1501.080427
   PubMed Web of Science ®Google Scholar
• Rahman M, Matthijnssens J, Yang X, Delbeke T, Arijs I, Taniguchi K, Iturriza-Gomara M, Iftekharuddin N, Azim T, Van Ranst M. Evolutionary history and global spread of the emerging g12 human rotaviruses. J Virol 2007; 81:2382-90; PMID:17166908; http://dx.doi.org/10.1128/JVI.01622-06
   PubMed Web of Science ®Google Scholar
• Wyatt RG, James WD, Bohl EH, Theil KW, Saif LJ, Kalica AR, Greenberg HB, Kapikian AZ, Chanock RM. Human rotavirus type 2: cultivation in vitro. Science 1980; 207:189-91; PMID:6243190; http://dx.doi.org/10.1126/science.6243190
   PubMed Web of Science ®Google Scholar
• Hoshino Y, Wyatt RG, Flores J, Midthun K, Kapikian AZ. Serotypic characterization of rotaviruses derived from asymptomatic human neonatal infections. J Clin Microbiol 1985; 21:425-30; PMID:2984247
   PubMed Web of Science ®Google Scholar