2,147
Views
12
CrossRef citations to date
0
Altmetric
Research Papers

A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India

, , , , &
Pages 1791-1799 | Received 03 Nov 2017, Accepted 07 Mar 2018, Published online: 12 Apr 2018

References

  • Burnett E, Jonesteller CL, Tate JE, Yen C, Parashar UD. Global impact of rotavirus vaccination on childhood hospitalizations and mortality from diarrhea. The J Infect Dis. 2017;215:1666–72. doi:10.1093/infdis/jix186. PMID:28430997.
  • Meeting of the immunization Strategic Advisory Group of Experts, April 2009–conclusions and recommendations. Wkly Epidemiol Rec. 2009;84:220–36. PMID:19499606.
  • Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, Goyal N, Kawade A, Kang G, Rathore SS, et al. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life. Vaccine. 2014;32 Suppl 1:A110–6. doi:10.1016/j.vaccine.2014.04.079. PMID:25091663.
  • http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/. accessed on 26th Janaury.
  • Ministry of Health & Family Welfare GoI. National Health Mission. Available at http://nrhm.gov.in/nrhm-components/rmnch-a/immunization/background.html accessed Dec 23, 2016.
  • GlaxoSmithKline. Rotarix®, Prescribing Information. Available at https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/rotarix/pi.html–section-34067-9. Accessed 23 Dec 2016.
  • Merck & CO. I. RotaTeq®, Prescribing Information. Available at http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf. Accessed 23 Dec 2016.
  • PATH. PATH welcomes new promising study results for rotavirus vaccine candidate. Available at http://www.path.org/news/press-room/804/. Accessed on 8 Sep 2017.
  • Estes MK, Graham DY, Smith EM, Gerba CP. Rotavirus stability and inactivation. J General Virol. 1979;43:403–9. doi:10.1099/0022-1317-43-2-403.
  • Weiss C, Clark HF. Rapid inactivation of rotaviruses by exposure to acid buffer or acidic gastric juice. J General Virol. 1985;66:2725–30. doi:10.1099/0022-1317-66-12-2725.
  • Gryboski JW, ed. Gastrointestinal Problems in the Infant: W.B. Saunders and Company, 1983.
  • Barnett B. Viral gastroenteritis. Med Clin North Am. 1983;67:1031–58. doi:10.1016/S0025-7125(16)31165-8. PMID:6312212.
  • Feng N, Burns JW, Bracy L, Greenberg HB. Comparison of mucosal and systemic humoral immune responses and subsequent protection in mice orally inoculated with a homologous or a heterologous rotavirus. J Virol. 1994;68:7766–73. PMID:7966566.
  • Graham DY, Dufour GR, Estes MK. Minimal infective dose of rotavirus. Arch Virol. 1987;92:261–71. doi:10.1007/BF01317483. PMID:3028333.
  • Bhan MK, Lew JF, Sazawal S, Das BK, Gentsch JR, Glass RI. Protection conferred by neonatal rotavirus infection against subsequent rotavirus diarrhea. J Infect Dis. 1993;168:282–7. doi:10.1093/infdis/168.2.282. PMID:8393054.
  • Ing DJ, Glass RI, Woods PA, Simonetti M, Pallansch MA, Wilcox WD, Davidson BL, Sievert AJ. Immunogenicity of tetravalent rhesus rotavirus vaccine administered with buffer and oral polio vaccine. Am J Dis Children (1960). 1991;145:892–7.
  • Clark HF, Burke CJ, Volkin DB, Offit P, Ward RL, Bresee JS, et al. Safety, immunogenicity and efficacy in healthy infants of G1 and G2 human reassortant rotavirus vaccine in a new stabilizer/buffer liquid formulation. Pediatric Infect Dis J. 2003;22:914–20. doi:10.1097/01.inf.0000091887.48999.77.
  • Kerdpanich A, Chokephaibulkit K, Watanaveeradej V, Vanprapar N, Simasathien S, Phavichitr N, Bock HL, Damaso S, Hutagalung Y, Han HH. Immunogenicity of a live-attenuated human rotavirus RIX4414 vaccine with or without buffering agent. Hum Vaccin. 2010;6:10428. doi:10.4161/hv.6.3.10428. PMID:20220306.
  • Mansoor OD, Kristensen D, Meek A, Zipursky S, Popovaa O, Sharma I, Miranda G, Millogo J, Lasher H. Vaccine presentation and packaging advisory group: a forum for reaching consensus on vaccine product attributes. Bulletin World Health Organization. 2013;91:75–8. doi:10.2471/BLT.12.110700.
  • Department of Immunization VaB, World Health Organization. Assessing the Programmatic Suitability of Vaccine Candidates for WHO Prequalification – Revision 2014. (WHO/IVB/14.10). Available at http://www.who.int/immunization_standards/vaccine_quality/ps_pq/en/, Accessed 24 Mar 2017. 2014.
  • Sack DA, Shimko J, Sack RB, Gomes JG, MacLeod K, O'Sullivan D, Spriggs D. Comparison of alternative buffers for use with a new live oral cholera vaccine, Peru-15, in outpatient volunteers. Infect Immun. 1997;65:2107–11. PMID:9169739.
  • Clemens J, Shin S, Sur D, Nair GB, Holmgren J. New-generation vaccines against cholera. Nat Rev Gastroenterol Hepatol. 2011;8:701–10. doi:10.1038/nrgastro.2011.174. PMID:22064524.
  • Levine MM, Chen WH, Kaper JB, Lock M, Danzig L, Gurwith M. PaxVax CVD 103-HgR single-dose live oral cholera vaccine. Exp Rev Vaccines. 2017;16:197–213. doi:10.1080/14760584.2017.1291348.
  • Greenberg HB, Estes MK. Rotaviruses: from pathogenesis to vaccination. Gastroenterology. 2009;136:1939–51. doi:10.1053/j.gastro.2009.02.076. PMID:19457420.
  • Bishop R, Davidson GP, Holmes IH, Ruck BJ. Virus particles in epithelial cells of duodenal mucosa from children with acute non-bacterial gastroenteritis. Lancet. 1973;302:1281–3. doi:10.1016/S0140-6736(73)92867-5.
  • Brunet JP, Cotte-Laffitte J, Linxe C, Quero AM, Geniteau-Legendre M, Servin A. Rotavirus infection induces an increase in intracellular calcium concentration in human intestinal epithelial cells: role in microvillar actin alteration. J Virol. 2000;74:2323–32. doi:10.1128/JVI.74.5.2323-2332.2000. PMID:10666263.
  • Offit PA, Clark HF, Kornstein MJ, Plotkin SA. A murine model for oral infection with a primate rotavirus (simian SA11). J Virol. 1984;51:233–6. PMID:6328042.
  • Medecines Sans Frontieres N, Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger In: ClinicalTrials.gov. Available at http://clinicaltrials.gov/show/NCT02145000NLMIdentifier:NCT02145000. Accessed 23 Dec 2016.
  • Dhingra MS, Kundu R, Gupta M, Kanungo S, Ganguly N, Singh MP, Bhattacharya MK, Ghosh R, Kumar R, Sur D, et al. Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants. Vaccine. 2014;32 Suppl 1:A117–23. doi:10.1016/j.vaccine.2014.03.069. PMID:25091664.
  • Bhandari N, Sharma P, Taneja S, Kumar T, Rongsen-Chandola T, Appaiahgari MB, Mishra A, Singh S, Vrati S; Rotavirus Vaccine Development Group. A dose-escalation safety and immunogenicity study of live attenuated oral rotavirus vaccine 116E in infants: a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2009;200:421–9. doi:10.1086/600104. PMID:19545211.
  • Washington N, Spensley PJ, Smith CA, Parker M, Bush D, Jackson SJ, Kapila L, Stephenson T, Washington C. Dual pH probe monitoring versus single pH probe monitoring in infants on milk feeds: the impact on diagnosis. Arch Dis Child. 1999;81:309–12. doi:10.1136/adc.81.4.309. PMID:10490434.
  • Vesikari T, Ruuska T, Delem A, Andre FE. Oral rotavirus vaccination in breast- and bottle-fed infants aged 6 to 12 months. Acta Paediatrica Scandinavica. 1986;75:573–8. doi:10.1111/j.1651-2227.1986.tb10253.x. PMID:3019074.
  • Moon SS, Wang Y, Shane AL, Nguyen T, Ray P, Dennehy P, et al. Inhibitory effect of breast milk on infectivity of live oral rotavirus vaccines. Pediatric Infect Dis J. 2010;29:919–23. doi:10.1097/INF.0b013e3181e232ea.
  • Ali A, Kazi AM, Cortese MM, Fleming JA, Moon S, Parashar UD, Jiang B, McNeal MM, Steele D, Bhutta Z, et al. Impact of withholding breastfeeding at the time of vaccination on the immunogenicity of oral rotavirus vaccine–a randomized trial. PLoS One. 2015;10:e0127622. doi:10.1371/journal.pone.0127622. PMID:26035743.
  • Chan J, Nirwati H, Triasih R, Bogdanovic-Sakran N, Soenarto Y, Hakimi M, Duke T, Buttery JP, Bines JE, Bishop RF, et al. Maternal antibodies to rotavirus: Could they interfere with live rotavirus vaccines in developing countries? Vaccine. 2011;29:1242–7. doi:10.1016/j.vaccine.2010.11.087. PMID:21147127.
  • Appaiahgari MB, Glass R, Singh S, Taneja S, Rongsen-Chandola T, Bhandari N, Mishra S, Vrati S. Transplacental rotavirus IgG interferes with immune response to live oral rotavirus vaccine ORV-116E in Indian infants. Vaccine. 2014;32:651–6. doi:10.1016/j.vaccine.2013.12.017. PMID:24374502.
  • Tiku VR, Sharma S, Verma A, Kumar P, Raghavendhar S, Aneja S, Paul VK, Bhan MK, Ray P. Rotavirus diversity among diarrheal children in Delhi, India during 2007–2012. Vaccine. 2014;32 Suppl 1:A62–7. doi:10.1016/j.vaccine.2014.03.005. PMID:25091683.
  • Mishra V, Awasthi S, Nag VL, Tandon R. Genomic diversity of group A rotavirus strains in patients aged 1–36 months admitted for acute watery diarrhoea in northern India: a hospital-based study. Clin Microbiol Infect. 2010;16:45–50. doi:10.1111/j.1469-0691.2009.02772.x. PMID:19456832.
  • Sharma S, Ray P, Gentsch JR, Glass RI, Kalra V, Bhan MK. Emergence of G12 rotavirus strains in Delhi, India, in 2000 to 2007. J Clin Microbiol. 2008;46:1343–8. doi:10.1128/JCM.02358-07. PMID:18272705.
  • Jain V, Das BK, Bhan MK, Glass RI, Gentsch JR. Great diversity of group A rotavirus strains and high prevalence of mixed rotavirus infections in India. J Clin Microbiol. 2001;39:3524–9. doi:10.1128/JCM.39.10.3524-3529.2001. PMID:11574567.
  • Ramachandran M, Das BK, Vij A, Kumar R, Bhambal SS, Kesari N, Rawat H, Bahl L, Thakur S, Woods PA, et al. Unusual diversity of human rotavirus G and P genotypes in India. J Clin Microbiol. 1996;34:436–9. PMID:8789033.
  • Narang A, Bose A, Pandit AN, Dutta P, Kang G, Bhattacharya SK, Datta SK, Suryakiran PV, Delem A, Han HH, et al. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Hum Vaccines. 2009;5:414–9. doi:10.4161/hv.5.6.8176.
  • Kompithra RZ, Paul A, Manoharan D, Babji S, Sarkar R, Mathew LG, Kang G. Immunogenicity of a three dose and five dose oral human rotavirus vaccine (RIX4414) schedule in south Indian infants. Vaccine. 2014;32 Suppl 1:A129–33. doi:10.1016/j.vaccine.2014.03.002. PMID:25091666.
  • Cunliffe NA, Witte D, Ngwira BM, Todd S, Bostock NJ, Turner AM, Chimpeni P, Victor JC, Steele AD, Bouckenooghe A, et al. Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian children in the first two years of life: A randomized, double-blind, placebo controlled trial. Vaccine. 2012;30, Supplement 1:A36–43. doi:10.1016/j.vaccine.2011.09.120. PMID:22520135.
  • Lawrence J, He S, Martin J, Schödel F, Ciarlet M, Murray AV. Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind, placebo-controlled study in healthy elderly subjects. Hum Vaccin Immunother. 2014;10:2247–54. doi:10.4161/hv.29107. PMID:25424929.
  • Madhi SA, Kirsten M, Louw C, Bos P, Aspinall S, Bouckenooghe A, Neuzil KM, Steele AD. Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine. 2012;30 Suppl 1:A44–51. doi:10.1016/j.vaccine.2011.08.080. PMID:22520136.
  • Steele AD, Reynders J, Scholtz F, Bos P, de Beer MC, Tumbo J, Van der Merwe CF, Delem A, De Vos B. Comparison of 2 different regimens for reactogenicity, safety, and immunogenicity of the live attenuated oral rotavirus vaccine RIX4414 coadministered with oral polio vaccine in South African infants. J Infect Dis. 2010;202 Suppl:S93–100. doi:10.1086/653550. PMID:20684724.
  • Mwenda JM, Ntoto KM, Abebe A, Enweronu-Laryea C, Amina I, Mchomvu J, Kisakye A, Mpabalwani EM, Pazvakavambwa I, Armah GE, et al. Burden and epidemiology of rotavirus diarrhea in selected African countries: preliminary results from the African Rotavirus Surveillance Network. J Infect Dis. 2010;202 Suppl:S5–S11. doi:10.1086/653557. PMID:20684718.
  • Armah GE, Breiman RF, Tapia MD, Dallas MJ, Neuzil KM, Binka FN, Sow SO, Ojwando J, Ciarlet M, Steele AD. Immunogenicity of the pentavalent rotavirus vaccine in African infants. Vaccine. 2012;30 Suppl 1:A86–93. doi:10.1016/j.vaccine.2011.10.006. PMID:22520142.
  • Bines JE, Kohl KS, Forster J, Zanardi LR, Davis RL, Hansen J, Murphy TM, Music S, Niu M, Varricchio F, et al. Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004;22:569–74. doi:10.1016/j.vaccine.2003.09.016. PMID:14741146.