Safety and immunogenicity of a new equine tetanus immunoglobulin associated with tetanus-diphtheria vaccine.
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| Abstract |
In a single-center double-blind, randomized trial in West Africa, we evaluated the safety and immunogenicity of a new pasteurized, pepsin-digested equine tetanus immunoglobulin (heat-treated equine tetanus immunoglobulin [HT-ETIG]) in the post-exposure prophylaxis of tetanus compared with the reference product, equine tetanus immunoglobulin (ETIG). A total of 134 adults presenting to Garoua Hospital, Cameroon with a tetanus-prone wound were randomized to receive a 3,000 international units (IU) intramuscular injection (deltoid) of either HT-ETIG or ETIG, simultaneously with a tetanus-diphtheria vaccine. No serious adverse reactions were reported. The incidences of local and systemic reactions were similar in the two groups. Repeated measures of equine tetanus-antibody levels measured from Day 0 to Day 28 showed that titers were significantly higher in the HT-ETIG group (P = 0.017). At Day 7, a higher percentage of subjects in the HT-ETIG group had equine antibody levels > or = 0.1 IU/ml (80.4% versus 37.9%; P < 0.0001). No cases of tetanus occurred during the follow-up, attesting to the efficacy of the combined prophylactic treatment.
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| Authors | J Lang, L Kamga-Fotso, J C Peyrieux, C Blondeau, C Lutsch, R Forrat |
| Journal | The American journal of tropical medicine and hygiene (Am J Trop Med Hyg) 2000 Nov-Dec Vol. 63 Issue 5-6 Pg. 298-305 ISSN: 0002-9637 [Print] United States |
| PMID | 11421382 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't) |
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