The role of aluminium for adverse reactions and immunogenicity of diphtheria-tetanus booster vaccine.

In a randomized, double-blind clinical trial, 235 schoolchildren aged 10 years received either a regular, aluminium-adsorbed diphtheria-tetanus vaccine or the same vaccine in fluid form, in order to investigate if local side effects could be diminished by exclusion of aluminium. System reactions were rare and local reactions frequent in both groups but larger local reactions were even more pronounced in the non-adsorbed vaccine group. Antibody responses to both vaccines were excellent and even slightly higher to the non-adsorbed diphtheria-tetanus vaccine (p = 0.0135 and 0.0014 for anti-diphtheria and anti-tetanus, respectively). This study has shown that fluid diphtheria-tetanus vaccine does not solve the problem of extensive local side effects induced by the diphtheria-tetanus school booster. Alternative strategies, such as changes in vaccine composition, dosage and spacing, will have to be considered.