Resumo

OCHOA, Rolando Felipe et al. Reactogenicity and immunogenicity of a new tetanus toxoid and reduced diphtheria toxoid vaccine in Cuban teenagers. Vaccimonitor [online]. 2006, vol.15, n.2, pp. 13-17. ISSN 1025-0298.

A randomized, controlled and double-blind trial was carried out in 225 Cuban teenagers aged 13-16 to evaluate the reactogenicity and immunogenicity of a new tetanus toxoid and reduced diphtheria toxoid vaccine (Finlay Institute) with respect to IMOVAX dT adult control vaccine (Aventis Pasteur). Serum samples were taken before and 21 days after immunization. The reactogenicity of both vaccines was similar. The general and local adverse events were mild and mainly detected in the first 72 hours after vaccination. All volunteers showed protective levels of tetanus antitoxin and diphtheria antitoxin (³0.1 IU/mL). 99.25% of subjects who received the experimental vaccine and 98.36% of control subjects showed long-term protective values of tetanus antitoxin (³1.0 IU/mL). These diphtheria antitoxin levels were respectively detected in 81.20% and 80.33% of volunteers.The geometric mean titer values for tetanus antitoxin and diphtheria antitoxin induced after vaccination were 21.73 IU/mL and 2.55 IU/mL respectively, higher than antitoxin levels of control group: 15.55 IU/mL and 1.84 IU/mL respectively (p<0.05).

Palavras-chave : Tetanus; diphtheria; vaccine; reactogenicity; immunogenicity; clinical trials; antitoxin.

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