Safety and immunogenicity of a primary series of Sabin-IPV with and without aluminum hydroxide in infants

Vaccine

Volumn 32, Issue 39, 2014, Pages 4938-4944

  Verdijk, Pauline ^a   Rots, Nynke Y ^b   van Oijen, Monique G C T ^a   Weldon, William C ^c   Oberste, M Steven ^c   Okayasu, Hiromasa ^d   Sutter, Roland W ^d   Bakker, Wilfried A M ^a  

^a Institute for Translational Vaccinology   (Netherlands)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Adjuvant; Aluminum hydroxide; Clinical trial; Immunogenicity; Inactivated poliovirus vaccine; Infants; Sabin strains; Safety

Indexed keywords

ALUMINUM HYDROXIDE; NEUTRALIZING ANTIBODY; POLIOMYELITIS VACCINE; IMMUNOLOGICAL ADJUVANT; LIVE VACCINE; ORAL POLIOMYELITIS VACCINE; VIRUS ANTIBODY;

ANTIBODY TITER; ARTICLE; BEHAVIOR CHANGE; CONTROLLED STUDY; CRYING; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; FECES; FEEDING BEHAVIOR; FEMALE; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INFANT; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; IRRITABILITY; LOW DRUG DOSE; LOWEST INCOME GROUP; MALE; MUSCLE RIGIDITY; MYALGIA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POLAND; POLIOMYELITIS; POLIOMYELITIS VIRUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SIDE EFFECT; SLEEP PATTERN; TYPE STRAIN; VIRAL CLEARANCE; VIRUS ATTENUATION; VIRUS NEUTRALIZATION; VIRUS STRAIN; VOMITING; WILD TYPE; ANTIBODY PRODUCTION; BLOOD; CLINICAL TRIAL; MULTICENTER STUDY;

ADJUVANTS, IMMUNOLOGIC; ALUMINUM HYDROXIDE; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; ANTIBODY FORMATION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFANT; MALE; POLAND; POLIOMYELITIS; POLIOVIRUS VACCINE, ORAL; VACCINES, ATTENUATED;

EID: 84906096645     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.07.029     Document Type: Article

References (27)

1. Global eradication of poliomyelitis by the year 2000. Forty-first world health assembly. WHA41.281988.
2. Meeting of the Strategic Advisory Group of Experts on immunization, November 2012 - conclusions and recommendations. Wkly Epidemiol Rec 2013, 88:1-16.
3. Minor P. Vaccine-derived poliovirus (VDPV): impact on poliomyelitis eradication. Vaccine 2009, 27:2649-2652.
4. Chumakov K., Ehrenfeld E. New generation of inactivated poliovirus vaccines for universal immunization after eradication of poliomyelitis. Clin Infect Dis 2008, 47:1587-1592.
5. Polio vaccines and polio immunization in the pre-eradication era: WHO position paper-recommendations. Vaccine 2010, 28:6943-6944.
6. Heinsbroek E., Ruitenberg E.J. The global introduction of inactivated polio vaccine can circumvent the oral polio vaccine paradox. Vaccine 2010, 28:3778-3783.
7. Kreeftenberg H., van der Velden T., Kersten G., van der Heuvel N., de Bruijn M. Technology transfer of Sabin-IPV to new developing country markets. Biologicals 2006, 34:155-158.
8. Verdijk P., Rots N.Y., Bakker W.A. Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains. Expert Rev Vaccines 2011, 10:635-644.
9. Doi Y., Abe S., Yamamoto H., Horie H., Ohyama H., Satoh K., et al. Progress with inactivated poliovirus vaccines derived from the Sabin strains. Dev Biol (Basel) 2001, 105:163-169.
10. Okada K., Miyazaki C., Kino Y., Ozaki T., Hirose M., Ueda K. Phase II and III clinical studies of diphtheria-tetanus-acellular pertussis vaccine containing inactivated polio vaccine derived from Sabin strains (DTaP-sIPV). J Infect Dis 2013, 208:275-283.
11. Adsorbed Purified Pertussis Diptheria Tetanus Inactivated Poliomyelitis (Sabin strain) Combined Vaccine. Notice of Marketing Authorization Approval, July 27, 2012. Astellas Pharma Inc. Available at: [accessed 11.02.14]. http://www.astellas.com/en/corporate/news/pdf/120727_Eg.pdf.
12. Liao G., Li R., Li C., Sun M., Li Y., Chu J., et al. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis 2012, 205:237-243.
13. Aylward B.R., Sutter R.W., Cochi S.L., Thompson K.M., Jafari H., Heymann D. Risk management in a polio-free world. Risk Anal 2006, 26:1441-1448.
14. Heymann D.L., Sutter R.W., Aylward R.B. A global call for new polio vaccines. Nature 2005, 434:699-700.
15. Bakker W.A., Thomassen Y.E., van't Oever A.G., Westdijk J., van Oijen M.G., Sundermann L.C., et al. Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV. Vaccine 2011, 29:7188-7196.
16. van Steenis G., van Wezel A.L., Sekhuis V.M. Potency testing of killed polio vaccine in rats. Dev Biol Stand 1981, 47:119-128.
17. Wood D.J., Heath A.B. A WHO collaborative study of immunogenicity assays of inactivated poliovirus vaccines. Biologicals 1995, 23:301-311.
18. Westdijk J., Brugmans D., Martin J., van't Oever A., Bakker W.A., Levels L., et al. Characterization and standardization of Sabin based inactivated polio vaccine: proposal for a new antigen unit for inactivated polio vaccines. Vaccine 2011, 29:3390-3397.
19. Westdijk J., Koedam P., Barro M., Steil B.P., Collin N., Vedvick T.S., et al. Antigen sparing with adjuvanted inactivated polio vaccine based on Sabin strains. Vaccine 2013, 31:1298-1304.
20. Thomassen Y.E., van't Oever A.G., van Oijen M.G., Wijffels R.H., van der Pol L.A., Bakker W.A. Next generation inactivated polio vaccine manufacturing to support post polio-eradication biosafety goals. PLOS ONE 2013, 8:e83374.
21. Verdijk P., Rots N.Y., van Oijen M.G., Oberste M.S., Boog C.J., Okayasu H., et al. Safety and immunogenicity of inactivated poliovirus vaccine based on Sabin strains with and without aluminum hydroxide: a phase I trial in healthy adults. Vaccine 2013, 31:5531-5536.
22. Plotkin S.A. Correlates of protection induced by vaccination. Clin Vaccine Immunol 2010, 17:1055-1065.
23. Report on the Deliberation Results, 23 July 2012. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare. Available at: [accessed 27.03.14]. http://www.pmda.go.jp/english/service/pdf/drugs/quattrovac_july2012_e.pdf.
24. Simizu B., Abe S., Yamamoto H., Tano Y., Ota Y., Miyazawa M., et al. Development of inactivated poliovirus vaccine derived from Sabin strains. Biologicals 2006, 34:151-154.
25. Dragunsky E.M., Ivanov A.P., Wells V.R., Ivshina A.V., Rezapkin G.V., Abe S., et al. Evaluation of immunogenicity and protective properties of inactivated poliovirus vaccines: a new surrogate method for predicting vaccine efficacy. J Infect Dis 2004, 190:1404-1412.
26. Tano Y., Shimizu H., Martin J., Nishimura Y., Simizu B., Miyamura T. Antigenic characterization of a formalin-inactivated poliovirus vaccine derived from live-attenuated Sabin strains. Vaccine 2007, 25:7041-7046.
27. Kersten G., Hazendonk T., Beuvery C. Antigenic and immunogenic properties of inactivated polio vaccine made from Sabin strains. Vaccine 1999, 17:2059-2066.