Monovalent type 1 oral poliovirus vaccine among infants in India: Report of two randomized double-blind controlled clinical trials

Vaccine

Volumn 29, Issue 34, 2011, Pages 5793-5801

  John, T Jacob ^a   Jain, Hemant ^b   Ravishankar, Kanithi ^c   Amaresh, A ^c   Verma, Harish ^d   Deshpande, Jagadish ^e   Pallansch, Mark A ^f   Singh, Ajit Pal ^g   Sreevatsava, Meghana ^d   Burton, Anthony ^d   Malankar, Pradeep ^d   Chatterjee, Arani ^g   Sutter, Roland W ^d  

^a MGM Medical College ^*

^b MGM MEDICAL COLLEGE   (India)

^c Niloufer Hospital India   (India)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

^e Enterovirus Research Centre   (India)

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

^g Panacea Biotec Ltd   (India)

Author keywords

Birth dose; Controlled trial; Immunogenicity; Monovalent type 1 oral poliovirus vaccine; Polio vaccine

Indexed keywords

MONOVALENT TYPE 1 ORAL POLIOMYELITIS VACCINE; ORAL POLIOMYELITIS VACCINE; UNCLASSIFIED DRUG;

ARTICLE; BACTERIAL MENINGITIS; BRONCHIOLITIS; BRONCHOPNEUMONIA; CLINICAL ASSESSMENT; CLINICAL EVALUATION; COMPARATIVE STUDY; CONTROLLED STUDY; DIARRHEA; DRUG FORMULATION; DRUG POTENCY; DUODENUM DISEASE; ENTEROVIRUS INFECTION; HUMAN; IMMUNOGENICITY; LACTOSE INTOLERANCE; MAJOR CLINICAL STUDY; NONHUMAN; PNEUMONIA; POLIOMYELITIS VIRUS 1; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEPSIS; SEROCONVERSION;

ANTIBODIES, VIRAL; FEMALE; HUMANS; IMMUNIZATION PROGRAMS; INDIA; INFANT, NEWBORN; MALE; POLIOMYELITIS; POLIOVIRUS; POLIOVIRUS VACCINE, ORAL;

EID: 79960560679     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.04.133     Document Type: Article

References (36)

1. World Health Assembly Global eradication of poliomyelitis by the year 2000 1988, World Health Organization, Geneva, [resolution WHA 41.28].
2. World Health Organization Progress towards interruption of wild poliovirus transmission, January 2007-April 2008. Wkly Epidemiol Rec 2008, 83:170-176.
3. Grassly N.C., Fraser C., Wenger J., Deshpande J.M., Sutter R.W., Heymann D.L., Aylward R.B. New strategies for the elimination of polio from India. Science 2006, 314:1150-1153.
4. Grassly N.C., Wenger J., Durrani S., Bahl S., Deshpande J.M., Sutter R.W., Heymann D.L., Aylward R.B. Protective efficacy of a monovalent oral type 1 poliovirus vaccine. Lancet 2007, 369:1356-1362.
5. John T.J., Jayabal P. Oral polio vaccination of children in the tropics. I. The poor seroconversion rates and the absence of viral interference. Am J Epidemiol 1972, 96:263-269.
6. Patriarca P.A., Wright P.F., John T.J. Factors affecting the immunogenicity of oral poliovirus vaccine in developing countries: review. Rev Infect Dis 1991, 13:929-939.
7. Pal S.R., Banerjee G., Aikat B.K. Serological investigation on endemnicity of poliomyelitis in Calcutta and in a neighboring rural area. Ind J Med Res 1966, 54:507-511.
8. World Health Organization Conclusions and recommendations of the Ad Hoc Advisory Committee on Poliomyelitis Eradication, Geneva, 21-22 September 2004. Wkly Epidemiol Rec 2005, 47:410-416.
9. Polio Eradication. Report of the 12th Meeting of the India Expert Advisory Group for Polio Eradication Delhi, India 2-3 December 2004.
10. Polio Eradication. Report of the 13th Meeting of the India Expert Advisory Group for Polio Eradication Delhi, India 3-4 May 2005.
11. John T.J., Devarajan L.V., Balasubramanyan A. Immunization in India with trivalent and monovalent poliovirus vaccines of enhanced potency. Bull WHO 1976, 54:115-117.
12. Caceres V.M., Sutter R.W. Sabin monovalent oral polio vaccines: review of past experiences and their potential use after polio eradication. Clin Infect Dis 2001, 33:531-541.
13. El-Sayed N., El-Gamal Y., Abbassy A.A., Seoud I., Salama M., Kandeel A., Hossny E., Shawky A., Hussein H.A., Pallansch M.A., van der Avoort H.G.A.M., Burton A.H., Sreevatsava M., Malankar P., Wahdan M.H., Sutter R.W. Monovalent type 1 oral poliovirus vaccine in newborns. N Engl J Med 2008, 359:1655-1665.
14. Expanded Programme on Immunization. Report of a WHO Informal Consultation on Polio Neutralizing Antibody Assays, Nashville, 5-6 December 1991. Geneva: World Health Organization; 1991 [WHO/EPI/RD/91.3 Rev 1].
15. WHO Collaborative Study Group on Oral and Inactivated Poliovirus Vaccines Combined immunization of infants with oral and inactivated poliovirus vaccines: results of a randomized trial in The Gambia, Oman and Thailand. J Infect Dis 1997, 175(Suppl. 1):S215-S227.
16. Immunization, Vaccines & Biologicals Polio laboratory manual 2004, World Health Organization, Geneva, [WHO/IVB/04.10]. 4th ed.
17. R Development Core Team. R: A Language and Environment for Computing. R Foundation for Statistical Computing, Vienna, Austria; 2006. [accessed on 18.12.06]. http://www.r-project.org/.
18. SAS/STAT user's guide, version 6.4 1989, vol. 1. SAS Institute, Cary, NC. 4th ed.
19. Conover W.J. Practical nonparametric statistics 1971, John Wiley & Sons.
20. Efron B., Tibshirani R. An introduction to the bootstrap 1993, Chapman & Hall/CRC, London.
21. Sutter R.W., John T.J., Jain H., Agarkedkar S., Ramaman P.V., Verma H., Deshpande J., Singh A.P., Sreevatsava M., Malankar P., Burton A., Chatterjee A., Jafari H., Aylward R.B. Randomized clinical trial of bivalent type 1 and 3 oral poliovirus vaccine. Lancet 2010, 376:1682-1688.
22. John T.J. Immune response of neonates to oral polio vaccine. Br Med J 1984, 289:881.
23. Dong D.X., Hu X.M., Liu W.J., Li J.S., Jin Y.C., Tan S.G., Chen T.Q., Fu J.Z., Niu B.Y., Yu H.M., Zhou Y. Immunization of neonates with trivalent oral poliomyelitis vaccine (Sabin). Bull World Health Org 1986, 64:853-860.
24. Sutter R.W., Patriarca P.A., Suleiman A.J.M., Pallansch M.A., Brogan S., Malankar P.G., Zell E.R., Al-Ghassani A.A.K., El-Bualy M.S. Paralytic poliomyelitis in Oman: association between regional differences in attack rate and variations in antibody responses to oral poliovirus vaccine. Int J Epidemiol 1993, 22:936-944.
25. Robertson S. Module 6. Poliomyelitis. The immunological basis for immunization series. Expanded programme on immunization, global programme for vaccines and immunization 1993, World Health Organization, Geneva, [WHO/EPI/GEN/93.16].
26. Schoub B.D., Johnson S., McAnerney J., Gilbertson L., Klaassen K.I., Reinach S.G. Monovalent neonatal polio immunization - a strategy for the developing world. J Infect Dis 1988, 157:836-839.
27. Halsey N., Galazka A. The efficacy of DTP and oral poliomyelitis immunization schedules initiated from birth to 12 weeks of age. Bull World Health Org 1985, 63:1151-1169.
28. Weckx L.Y., Schmidt B.J., Hermann A.A., et al. Early immunization of neonates with trivalent oral poliovirus vaccine. Bull World Health Organ 1992, 70:85-91.
29. John T.J., Devarajan L.V., Luther L., Vijayarathnam P. Effect of breast-feeding on seroresponse of infants to oral poliovirus vaccination. Pediatrics 1976, 57:47-53.
30. Domök I., Balayan M.S., Fayinka O.A., Skrtic N., Soneji A.D., Harland P.S. Factors affecting the efficacy of live poliovirus vaccine in warm climates. Efficacy of type 1 Sabin vaccine administered together with antihuman gamma-globulin horse serum to breast-fed and artificially fed infants in Uganda. Bull World Health Organ 1974, 51:333-347.
31. Levine S., Goldblum N., Friedmant E., et al. Virologic findings and antibody response of newborns fed multiple type oral poliomyelitis vaccine. Am J Epidemiol 1961, 74:95-102.
32. John T.J. Oral polio vaccination of children in the tropics. II. Antibody response in relation to vaccine virus infection. Am J Epidemiol 1975, 102:414-421.
33. Patriarca P.A., Laender F., Palmeira G., Oliveira M.J., Lima Filho J., Dantes M.C., Cordeiro M.T., Risi J.B., Orenstein W.A. Randomised trial of alternative formulations of oral poliovaccine in Brazil. Lancet 1988, i:429-433.
34. World Health Organization Collaborative Study Group on Oral Poliovirus Vaccine Factors affecting the immunogenicity of oral poliovirus vaccine: a prospective evaluation in Brazil and the Gambia. J Infect Dis 1995, 171:1097-1106.
35. Ramji S. The National Family Health Survey (1998-99): childhood mortality. Indian Pediatrics 2001, 38:263-266.
36. World Health Organization. [assessed 18.09.2010]. http://www.polioeradication.org/casecount.asp.