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Tetanus Toxoid Adsorbed

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Tetanus Toxoid Adsorbed

Tetanus Toxoid Adsorbed

CLINICAL PHARMACOLOGY

Tetanus is an intoxication manifested primarily by neuromuscular dysfunction caused by a potent exotoxin elaborated by Clostridium tetani.

The occurrence of tetanus in the United States (US) has decreased dramatically from 560 reported cases in 1947 to a record low of 48 reported cases in 1987. Tetanus in the US is primarily a disease of older adults. Of 99 tetanus patients with complete information reported to the Centers for Disease Control and Prevention (CDC) during 1987 and 1988, 68% were ≥ 50 years of age, while only six were < 20 years of age. Overall, the case-fatality rate was 21%. The age distribution of recent cases and the results of serosurveys indicate that many US adults are not protected against tetanus. Serosurveys undertaken since 1977 indicate that 6% to 11% of adults 18 to 39 years of age and 49% to 66% of those ≥ 60 years of age may lack protective levels of circulating tetanus antitoxin.1 In 1992, 45 cases were reported of which 82% were ≥ 50 years of age.2 The disease continues to occur almost exclusively among persons who are unvaccinated or inadequately vaccinated or whose vaccination histories are unknown or uncertain.1

In 4% of tetanus cases reported during 1987 and 1988, no wound or other condition was implicated. Non-acute skin lesions, such as ulcers, or medical conditions such as abscesses, were reported in association with 14% of cases.1

Neonatal tetanus occurs among infants born under unhygienic conditions to inadequately vaccinated mothers. Vaccinated mothers confer protection to their infants through transplacental transfer of maternal antibody. From 1972 through 1984, 29 cases of neonatal tetanus were reported in the United States. No cases of neonatal tetanus were reported in the period 1985 to 1989.1

Spores of C. tetani are ubiquitous. Serologic tests indicate that naturally acquired immunity to tetanus toxin does not occur in the US.1 Thus, universal primary vaccination, with subsequent maintenance of adequate antitoxin levels by means of appropriately timed boosters, is necessary to protect persons among all age-groups. Tetanus toxoid is a highly effective antigen, and a completed primary series generally induces protective levels of neutralizing antibodies to tetanus toxin that persist for ≥ 10 years.1

The efficacy of tetanus toxoid was determined on the basis of immunogenicity studies with a comparison to a serological correlate of protection (0.01 antitoxin units/mL) established by the Panel on Review of Bacterial Vaccines & Toxoids.3

Tetanus toxoid was administered to a previously unimmunized rural population 6 years of age and older. The primary immune response to tetanus toxoid in 46 persons had titers of 0.01 AU (antitoxin units) or more one month after the second and the third immunizations. The geometric mean titers at both nine and 61 weeks for children 6 to 18 years of age were significantly greater than for adults older than 18 years of age (P < .001).4

REFERENCES

1. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40: No. RR-10, 1991

2. Centers for Disease Control and Prevention (CDC), Summary of Notifiable Disease, United States 1992. MMWR 41: No. 55, 1993

3. Department of Health and Human Services, Food and Drug Administration. Biologicals Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Proposed Rule. Federal Register Vol 50 No 240, pp 51002-51117, 1985

4. Myers G, et al. Primary Immunization with Tetanus and Diphtheria Toxoids. JAMA 248: 2478-2480, 1982

Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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