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Ipol

CLINICAL PHARMACOLOGY

Poliomyelitis is caused by poliovirus Types 1, 2, or 3. It is primarily spread by the fecal-oral route of transmission but may also be spread by the pharyngeal route.

Approximately 90% to 95% of poliovirus infections are asymptomatic. Nonspecific illness with low-grade fever and sore throat (minor illness) occurs in 4% to 8% of infections. Aseptic meningitis occurs in 1% to 5% of patients a few days after the minor illness has resolved. Rapid onset of asymmetric acute flaccid paralysis occurs in 0.1% to 2% of infections, and residual paralytic disease involving motor neurons (paralytic poliomyelitis) occurs in approximately 1 per 1,000 infections.5

Prior to the introduction of inactivated poliovirus vaccines in 1955, large outbreaks of poliomyelitis occurred each year in the United States (US). The annual incidence of paralytic disease of 11.4 cases/100,000 population declined to 0.5 cases by the time oral poliovirus vaccine (OPV) was introduced in 1961. Incidence continued to decline thereafter to a rate of 0.002 to 0.005 cases per 100,000 population. Of the 127 cases of paralytic poliomyelitis reported in the US between 1980 and 1994, six were imported cases (caused by wild polioviruses), two were “ indeterminate” cases, and 119 were vaccine associated paralytic poliomyelitis (VAPP) cases associated with the use of live, attenuated oral poliovirus vaccine (OPV).6 An all IPVschedule was adopted in 1999, to eliminate VAPP cases.7

Poliovirus Vaccine Inactivated induces the production of neutralizing antibodies against each type of virus which are related to protective efficacy. Antibody response in most children were induced after receiving fewer doses8 of IPV vaccine than the vaccine available in the United States prior to 1988.

Studies in developed8 and developing9,10 countries with a similar enhanced IPV manufactured by the same process as IPOL (poliovirus vaccine inactivated) vaccine in primary monkey kidney cells have shown a direct relationship exists between the antigenic content of the vaccine, the frequency of seroconversion, and resulting antibody titer. Approval in the US was based upon demonstration of immunogenicity and safety in US children.11

In the US, 219 infants received three doses of a similar enhanced IPV at two, four and eighteen months of age manufactured by the same process as IPOL (poliovirus vaccine inactivated) vaccine except the cell substrate for IPV was using primary monkey kidney cells. Seroconversion to all three types of poliovirus was demonstrated in 99% of these infants after two doses of vaccine given at 2 and 4 months of age. Following the third dose of vaccine at 18 months of age, neutralizing antibodies were present at a level of ≥ 1:10 in 99.1% of children to Type 1 and 100% of children to Types 2 and 3 polioviruses.3

IPOL (poliovirus vaccine inactivated) vaccine was administered to more than 700 infants between 2 to 18 months of age during three clinical studies conducted in the US using IPV only schedules and sequential IPV-OPV schedules.12,13 Seroprevalence rates for detectable serum neutralizing antibody (DA) at a ≥ 1:4 dilution were 95% to 100% (Type 1); 97% to 100% (Type 2) and 96% to 100% (Type 3) after two doses of IPOL (poliovirus vaccine inactivated) vaccine depending on studies.

TABLE 1: US STUDIES WITH IPOL (poliovirus vaccine inactivated) VACCINE ADMINISTERED USING IPV ONLY OR SEQUENTIAL IPV-OPV SCHEDULES

Age (months) for Post Dose 2 Post Dose 3 Pre Booster Post Booster
2
Dose 1
4
Dose 2
6
Dose 3
12 to18
Booster
N* Type 1
%DA**
Type 2
%DA
Type 3
%DA
N* Type 1
%DA
Type 2
%DA
Type 3
%DA
N* Type 1
%DA
Type 2
%DA
Type 3
%DA
N* Type 1
%DA
Type 2
%DA
Type 3
%DA
STUDY 111
I(s) I(s) NA† I(s) 56 97 100 97   53 91 97 93 53 97 100 100
O O NA O 22 100 100 100   22 78 91 78 20 100 100 100
I(s) O NA O 17 95 100 95   17 95 100 95 17 100 100 100
I(s) I(s) NA O 17 100 100 100   16 100 100 94 16 100 100 100
STUDY 210§
I(c) I(c) NA I(s) 94 98 97 96   100 92 95 88 97 100 100 100
I(s) I(s) NA I(s) 68 99 100 99   72 100 100 94 75 100 100 100
I(c) I(c) NA O 75 95 99 96   77 86 97 82 78 100 100 97
I(s) I(s) NA O 101 99 99 95   103 99 97 89 107 100 100 100
STUDY 310§
I(c) I(c) I(c) O 91 98 99 100 91 100 100 100 41 100 100 100 40 100 100 100
I(c) I(c) O O 96 100 98 99 94 100 100 99 47 100 100 100 45 100 100 100
I(c) I(c) I(c)+ O O 91 96 97 100 85 100 100 100 47 100 100 100 46 100 100 100
* N = Number of children from whom serum was available
** Detectable antibody (neutralizing titer ≥ 1:4)
† NA - No poliovirus vaccine administered
¶ IPOL (poliovirus vaccine inactivated) vaccine given subcutaneously
§ IPOL (poliovirus vaccine inactivated) vaccine given intramuscularly
I IPOL (poliovirus vaccine inactivated) vaccine given either separately in association with DTP in two sites (s) or combined (c) with DTP in a dual chambered syringe
O OPV

In one study,13 the persistence of DA in infants receiving two doses of IPOL (poliovirus vaccine inactivated) vaccine at 2 and 4 months of age was 91% to 100% (Type 1), 97% to 100% (Type 2), and 93% to 94% (Type 3) at twelve months of age. In another study,12 86% to 100% (Type 1), 95% to 100% (Type 2), and 82% to 94% (Type 3) of infants still had DA at 18 months of age.

In trials and field studies conducted outside the US, IPOL (poliovirus vaccine inactivated) vaccine, or a combination vaccine containing IPOL (poliovirus vaccine inactivated) vaccine and DTP, was administered to more than 3,000 infants between 2 to 18 months of age using IPV only schedules and immunogenicity data are available from 1,485 infants. After two doses of vaccine given during the first year of life, seroprevalence rates for detectable serum neutralizing antibody (neutralizing titer ≥ 1:4) were 88% to 100% (Type 1); 84% to100% (Type 2) and 94% to 100% (Type 3) of infants, depending on studies. When three doses were given during the first yearof life, post-dose 3 DA ranged between 93% to 100% (Type 1); 89% to 100% (Type 2) and 97% to 100% (Type 3) and reached 100% for Types 1, 2, and 3 after the fourth dose given during the second year of life (12 to 18 months of age).14

In infants immunized with three doses of an unlicensed combination vaccine containing IPOL (poliovirus vaccine inactivated) vaccine and DTP given during the first year of life, and a fourth dose given during the second year of life, the persistence of detectable neutralizing antibodies was 96%, 96% and 97% against poliovirus Types 1, 2, and 3, respectively, at six years of age. DA reached 100% for all types after a booster dose of IPOL (poliovirus vaccine inactivated) vaccine combined with DTP vaccine.11 A survey of Swedish children and young adults given a Swedish IPV only schedule demonstrated persistence of detectable serum neutralizing antibody for at least 10 years to all three types of poliovirus.15

IPV is able to induce secretory antibody (IgA) produced in the pharynx and gut and reduces pharyngeal excretion of poliovirus Type 1 from 75% in children with neutralizing antibodies at levels less than 1:8 to 25% in children with neutralizing antibodies at levels more than 1:64.4,14,16-22 There is also evidence of induction of herd immunity with IPV,15,23-26 and that this herd immunity is sufficiently maintained in a population vaccinated only with IPV.26

VAPP has not been reported in association with administration of IPOL (poliovirus vaccine inactivated) vaccine.27 It is expected that an IPV only schedule will eliminate the risk of VAPP in both recipients and contacts compared to a schedule that included OPV.7

REFERENCES

5. Sabin AB. Poliomyelitis. In Brande AI, Davis CE, Fierer J (eds) International Textbook of Medicine, Vol II. Infectious Diseases and Medical Microbiology. 2nd ed. Philadelphia, WBSaunders, 1986

6. Prevots DR, et al. Vaccine-associated paralytic poliomyelitis in the United States, l980-1994: current risk and potential impact of a proposed sequential schedule of IPV followed by OPV (Abstract #H90). In: Abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC. American Society for Microbiology, 179, 1996

7. ACIP. Updated Recommendations of the Advisory Committee on Immunization Practices. Poliomyelitis Prevention in the United States. MMWR 49: No. RR-5, 2000

8. Salk J, et al. Antigen content of inactivated poliovirus vaccine for use in a one- or two-dose regimen. Ann Clin Res 14: 204-212, 1982

9. Salk J, et al. Killed poliovirus antigen titration in humans. Develop Biol Standard 41: 119-132, 1978

10. Salk J, et al. Theoretical and practical considerations in the application of killed poliovirus vaccine for the control of paralytic poliomyelitis. Develop Biol Standard 47: 181-198, 1981

11. Unpublished data available from Sanofi Pasteur SA

12. Unpublished data available from Sanofi Pasteur Inc.

13. Faden H, et al. Comparative evaluation of immunization with live attenuated and enhanced potency inactivated trivalent poliovirus vaccines in childhood: Systemic and local immune responses. J Infect Dis 162: 1291-1297, 1990

14. Vidor E, et al. The place of DTP/eIPV vaccine in routine pædiatric vaccination. Rev Med Virol 4: 261-277, 1994

15. Bottiger M. Long-term immunity following vaccination with killed poliovirus vaccine in Sweden, a country with no circulating poliovirus. Rev Infect Dis 6 (Suppl 2): S548-S551, 1984

16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835839, 1995

17. Marine WM, et al. Limitation of fecal and pharyngeal poliovirus excretion in Salk-vaccinated children. A family study during a Type 1 poliomyelitis epidemic. Amer J Hyg 76: 173-195, 1962

18. Bottiger M, et al. Vaccination with attenuated Type 1 poliovirus, the Chat strain. II. Transmission of virus in relation to age. Acta Paed Scand 55: 416-421, 1966

19. Dick GWA, et al. Vaccination against poliomyelitis with live virus vaccines. Effect of previous Salk vaccination on virus excretion. Brit Med J 2: 266-269, 1961

20. Wehrle PF, et al. Transmission of poliovirus; III. Prevalence of polioviruses in pharyngeal secretions of infected household contacts of patients with clinical disease. Pediatrics 27: 762-764, 1961

21. Adenyi-Jones SC, et al. Systemic and local immune responses to enhanced-potency inactivated poliovirus vaccine in premature and term infants. J Pediatr 120: No 5, 686-689, 1992

22. Chin TDY. Immunity induced by inactivated poliovirus vaccine and excretion of virus. Rev Infect Dis 6 (Suppl 2): S369-S370, 1984

23. Salk D. Herd effect and virus eradication with use of killed poliovirus vaccine. Develop Biol Standard 47: 247-255, 1981

24. Bijerk H. Surveillance and control of poliomyelitis in the Netherlands. Rev Infect Dis 6 (Suppl 2): S451-S456, 1984

25. Lapinleimu K. Elimination of poliomyelitis in Finland. Rev Infect Dis 6 (Suppl 2): S457-S460, 1984

26. Conyn van Spaendonck M, et al. Circulation of Poliovirus during the poliomyelitis outbreak in the Netherlands in 1992-1993. Amer J Epidemiology 143: 929-935, 1996

27. Strebel PM, et al. Epidemiology of poliomyelitis in the United States one decade after the last reported case of indigenous wild virus associated disease. Clin Infect Dis 14: 568-579, 1992

Last reviewed on RxList: 2/20/2009
This monograph has been modified to include the generic and brand name in many instances.

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