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

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.

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. Following adequate immunization with tetanus toxoid, it is thought that protection persists for at least 10 years. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assays, is considered the minimum protective level.² More recently, a level of = 0.1 to 0.2 IU/mL has been considered as protective.³

The efficacy of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. was determined on the basis of an immunogenicity study with a comparison to a serological correlate of protection (0.01 antitoxin units/mL) established by the Panel on Review of Bacterial Vaccines & Toxoids.²

A Tetanus and Diphtheria Toxoids absorbed For Adult Use vaccine manufactured by Aventis Pasteur Inc. was administered to a previously unimmunized rural population 6 to 58 years of age. Among 46 persons with serologic evidence for no pre-existing immunity to tetanus, all had titers of 0.01 AU (antitoxin units) or more, one month after the second and third immunizations.

No immunogenicity data are available on concomitant administration of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. with other US licensed vaccines.

REFERENCES

1. Centers for Disease Control and Prevention (CDC). Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Morb Mortal Wkly Rep. 1991;40(RR-10):1-28.

2. Department of Health and Human Services, Food and Drug Administration. Biological products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Federal Register. December 13, 1985;50(240):51002-51117.

3. CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR Morb Mortal Wkly Rep. 2002;51(RR-2):1-36.

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