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CLINICAL PHARMACOLOGY

Tetanus

Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by C tetani.

Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of 0.01 IU/mL, measured by neutralization assays, is considered the minimum protective level.2,3

Diphtheria

Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae.

Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection.3,4

Efficacy of DECAVAC (tetanus and diphtheria toxoids adsorbed) Vaccine

The efficacy of tetanus toxoid and diphtheria toxoid used in DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine 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.3

A clinical study to evaluate the serological responses and adverse reactions was performed in 58 individuals 6-58 years of age. The results indicated protective levels of antibody were achieved in greater than 90% of the study population after primary immunization with both components. Booster effects were achieved in 100% of the individuals with pre-existing antibody responses.5

REFERENCES

2. Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company;2008:805-839.

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

4. Vitek CR and Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company;2008:139-156.

5. Myers MG, et al. Primary immunization with tetanus and diphtheria toxoids. JAMA 248:1982;2478-2480.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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