Safety and immunogenicity of a new equine tetanus immunoglobulin associated with tetanus-diphtheria vaccine.
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.
Lang
J
J
Aventis Pasteur, Lyon, France.
Kamga-Fotso
L
L
Peyrieux
J C
JC
Blondeau
C
C
Lutsch
C
C
Forrat
R
R
D000293:Adolescent; D000328:Adult; D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood*; D003017:Clostridium tetani / Q000276:immunology*; D022422:Diphtheria-Tetanus Vaccine / Q000009:adverse effects; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006736:Horses; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D013742:Tetanus / Q000276:immunology* / Q000517:prevention & control*; D013745:Tetanus Toxoid / Q000009:adverse effects*
D000907:Antibodies, Bacterial; D022422:Diphtheria-Tetanus Vaccine; D013745:Tetanus Toxoid; C430265:heat-treated equine tetanus immunoglobulin