Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines

International Journal of Infectious Diseases

Volumn 16, Issue 2, 2012, Pages

  Cadorna Carlos, Josefina ^a   Vidor, Emmanuel ^b   Bonnet, Marie Claude ^b  

^a UNIVERSITY OF THE EAST   (Philippines)

^b SANOFI PASTEUR   (France)

Author keywords

Fractional dose; Inactivated polio vaccine; Intradermal

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; DIPLOID CELL VACCINE;

ANTIBODY TITER; ARTICLE; BRONCHOPNEUMONIA; CONTROLLED STUDY; DRUG FATALITY; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FILIPINO; HEALTH PROGRAM; HUMAN; IMMUNOGENICITY; INFANT; INJECTION; INJECTION SITE ERYTHEMA; MAJOR CLINICAL STUDY; MALE; NEEDLE; PHASE 2 CLINICAL TRIAL; PHILIPPINES; POLIOMYELITIS; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; TREATMENT RESPONSE; VACCINATION;

ANTIBODIES, VIRAL; ANTIBODY FORMATION; DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS VACCINES; FEMALE; HAEMOPHILUS VACCINES; HEPATITIS B VACCINES; HUMANS; IMMUNE TOLERANCE; IMMUNIZATION, SECONDARY; INFANT; INJECTIONS, INTRADERMAL; MALE; MASS VACCINATION; PHILIPPINES; POLIOMYELITIS; POLIOVIRUS VACCINE, INACTIVATED; VACCINATION; VACCINES, COMBINED;

EID: 84856002111     PISSN: 12019712     EISSN: 18783511     Source Type: Journal    
DOI: 10.1016/j.ijid.2011.10.002     Document Type: Article

References (33)

1. Progress towards interruption of wild poliovirus transmission worldwide, 2009. Wkly Epidemiol Rec 2010;85:178-84.
2. Kew O.M., Sutter R.W., de Gourville E.M., Dowdle W.R., Pallansch M.A. Vaccine-derived polioviruses and the endgame strategy for global polio eradication. Annu Rev Microbiol 2005, 59:587-635.
3. Minor P. Vaccine-derived poliovirus (VDPV): impact on poliomyelitis eradication. Vaccine 2009, 27:2649-2652.
4. Conclusions and recommendations of the Advisory Committee on Poliomyelitis Eradication, Geneva, 27-28 November 2007. Wkly Epidemiol Rec 2008;83:25-35.
5. Hickling J, Jones R, Nundy N. Improving the affordability of inactivated poliovirus vaccines (IPV) for use in low- and middle-income countries: an economic analysis of strategies to reduce the cost of routine IPV immunization. Seattle: PATH; 2010.
6. Nicolas J.F., Guy B. Intradermal, epidermal and transcutaneous vaccination: from immuology to clinical practice. Expert Rev Vaccines 2008, 7:1201-1214.
7. Hickling J.K., Jones K.R., Friede M., Zehrung D., Chen D., Kristensen D. Intradermal delivery of vaccines: potential benefits and current challenges. Bull World Health Organ 2011, 89:221-226.
8. WHO position paper. Wkly Epidemiol Rec 2010, 85:309-320. Rabies vaccines.
9. Salk J.E. Studies in human subjects on active immunization against poliomyelitis. I. A preliminary report of experiments in progress. J Am Med Assoc 1953, 151:1081-1098.
10. Salk J.E. Recent studies on immunization against poliomyelitis. Pediatrics 1953, 12:471-482.
11. Connolly J.H., Dick G.W. Antibody response following intradermal or oral administration of formalinised poliomyelitis. Lancet 1958, 2:333-336.
12. Hingson R.A., Davis H.S., Bloomfield R.A., Brailey R.F. Mass inoculation of the Salk polio vaccine with the multiple dose jet injector. GP 1957, 15:94-96.
13. Sigurdsson B., Gudnadottir M., Petursson G. Response to poliomyelitis vaccination. Lancet 1958, 1:370-371.
14. Lipson M.J., Carver D.H., Eleff M.G., Hingson R.A., Robbins F.C. Antibody response to poliomyelitis vaccine administered by jet injection. Am J Public Health Nations Health 1958, 48:599-603.
15. Skovranek V., Radkovsky J., Roudny J., Cervenka J., Pecenka J., Sovina J., et al. Vaccination against poliomyelitis in Czechoslovakia in 1957. II. Evaluation of morbidity following vaccination. J Hyg Epidemiol Microbiol Immunol 1958, 2:469-477.
16. Slonim D., Svandova E., Strand P., Benes C. History of poliomyelitis in the Czech Republic-Part III. Cent Eur J Public Health 1995, 3:124-126.
17. Von Magnus H., Von Magnus P., Petersen I., Godtfredsen A., Ronkjaer M. Polio vaccination in Denmark in April-June 1955. I. The production of formalinized poliovaccine and preliminary results. Dan Med Bull 1955, 2:226-233.
18. Nirmal S., Cherian T., Samuel B.U., Rajasingh J., Raghupathy P., John T.J. Immune response of infants to fractional doses of intradermally administered inactivated poliovirus vaccine. Vaccine 1998, 16:928-931.
19. Samuel B.U., Cherian T., Rajasingh J., Raghupathy P., John T.J. Immune response of infants to inactivated poliovirus vaccine injected intradermally. Vaccine 1992, 10:135.
20. Samuel B.U., Cherian T., Sridharan G., Mukundan P., John T.J. Immune response to intradermally injected inactivated poliovirus vaccine. Lancet 1991, 338:343-344.
21. Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nat Rev Drug Discov 2006, 5:543-548.
22. Mohammed A.J., AlAwaidy S., Bawikar S., Kurup P.J., Elamir E., Shaban M.M., et al. Fractional doses of inactivated poliovirus vaccine in Oman. N Engl J Med 2010, 362:2351-2359.
23. Resik S., Tejeda A., Lago P.M., Diaz M., Carmenates A., Sarmiento L., et al. Randomized controlled clinical trial of fractional doses of inactivated poliovirus vaccine administered intradermally by needle-free device in Cuba. J Infect Dis 2010, 201:1344-1352.
24. World Health Organization. Guidelines for WHO/EPI collaborative studies on poliomyelitis. Standard procedure for determining immunity to poliovirus using the microneutralization test. WHO/EPI/GEN 93.9. Geneva: WHO; 1993.
25. el-Sayed N., el-Gamal Y., Abbassy A.A., Seoud I., Salama M., Kandeel A., et al. Monovalent type 1 oral poliovirus vaccine in newborns. N Engl J Med 2008, 359:1655-1665.
26. Farrington C.P., Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 1990, 9:1447-1454.
27. Newcombe R.G. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med 1998, 17:857-872.
28. Minor P.D. Antigenic structure of picornaviruses. Curr Top Microbiol Immunol 1990, 161:121-154.
29. Albrecht P., Enterline J.C., Boone E.J., Klutch M.J. Poliovirus and polio antibody assay in HEp-2 and Vero cell cultures. J Biol Stand 1983, 11:91-97.
30. Boone E.J., Albrecht P. Conventional and enhanced plaque neutralization assay for polio antibody. J Virol Methods 1983, 6:193-202.
31. Wood D.J., Heath A.B. Comparability of poliovirus neutralizing antibody tests. Biologicals 1992, 20:293-300.
32. Kitchin N., Southern J., Morris R., Borrow R., Fiquet A., Boisnard F., et al. Antibody persistence in UK pre-school children who received a primary series of an acellular pertussis-containing pentavalent infant vaccine given concomitantly with meningococcal group C conjugate vaccine, and response to a booster dose of an acellular pertussis-containing quadrivalent vaccine. Vaccine 2009, 27:5096-5102.
33. Guerra F.A., Blatter M.M., Greenberg D.P., Pichichero M., Noriega F.R. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a pre-school booster dose: a randomized, clinical trial. Pediatrics 2009, 123:301-312.