Effects of lowering the aluminium content of a dTpa vaccine on its immunogenicity and reactogenicity when given as a booster to adolescents

• Published in: Vaccine Vol. 23; no. 12; pp. 1515 - 1521
• Main Authors: Theeten, H., Van Damme, P., Hoppenbrouwers, K., Vandermeulen, C., Leback, E., Sokal, E.M., Wolter, J., Schuerman, L.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 10.02.2005; Elsevier; Elsevier Limited
• Subjects: Adjuvants, Immunologic - chemistry; Adjuvants, Immunologic - pharmacology; Adolescent; Adolescents; Aluminium; Aluminum; Aluminum - chemistry; Aluminum - pharmacology; Antibodies, Bacterial - blood; Antigens; Applied microbiology; Belgium; Biological and medical sciences; Booster vaccine; Child; Confidence intervals; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects; Diphtheria-Tetanus-acellular Pertussis Vaccines - chemistry; Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology; Disease; Enzyme-Linked Immunosorbent Assay; Family medical history; Female; Fundamental and applied biological sciences. Psychology; Humans; Immunization, Secondary; Immunogenicity; Male; Microbiology; Pertussis; Side effects; Tetanus; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Whooping cough; Belgium; Pertussis; Aluminium; Tetanus; Booster vaccine; Diphtheria; Adolescents; Human; Immunogenicity; Booster vaccination; Toxicity; Adolescent; Vaccine
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2004.08.002

As aluminium in vaccines has been associated with the incidence of local side effects occurring after vaccination, this observer-blind randomised clinical trial was designed to evaluate the effect of lowering the aluminium content of a combined reduced-antigen-content dTpa vaccine on immunogenicity and safety when administered to healthy adolescents aged 10–18 years. A total of 647 subjects were enrolled, 224 (35%) received a dTpa formulation with 0.5 mg aluminium, 209 (32%) a formulation with 0.3 mg aluminium and 214 (33%) a formulation with 0.133 mg aluminium. One month after boostering, all subjects were seroprotected against diphtheria and tetanus toxoids. All subjects were seropositive for anti-FHA and anti-PRN but 4% of the initially seronegatives in both reduced aluminium groups did not seroconvert for anti-PT. Booster responses did not differ significantly between groups for any antibody, but post booster vaccination anti-PT GMC's differed significantly between groups and decreased when vaccine aluminium content decreased. No clear difference between study groups in local or general side effects was demonstrated. The most frequently reported symptoms after vaccination were injection site pain (89.5–90.7%), fatigue (42.1–47.4%) and headache (41.1–45.1%). This study showed that the aluminium content has a specific influence on the immunogenicity of this dTpa vaccine.