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 evalua ted the safety and immunogenicity of a new pasteurized, pepsin-digested equ ine tetanus immunoglobulin (heat-treated equine tetanus immunoglobulin [HT- ETIG]) in the post-exposure prophylaxis of tetanus compared with the refere nce product, equine tetanus immunoglobulin (ETIG). A total of 134 adults pr esenting to Garoua Hospital, Cameroon with a tetanus-prone wound were rando mized to receive a 3,000 international units (IU) intramuscular injection ( deltoid) of either HT-ETIG or ETIG, simultaneously with a tetanus-diphtheri a vaccine. No serious adverse reactions were reported. The incidences of lo cal and systemic reactions were similar in the two groups. Repeated measure s of equine tetanus-antibody levels measured from Day 0 to Day 28 showed th at titers were significantly higher in the HT-ETIG group (P = 0.017). At Da y 7, a higher percentage of subjects in the HT-ETIG group had equine antibo dy levels greater than or equal to 0.1 IU/ mi (80.4% versus 37.9%: P < 0.00 01). No cases of tetanus occurred during the follow-up. attesting to the ef ficacy of the combined prophylactic treatment.