Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium. Issue 26 (12th June 2015)

• Record Type: Journal Article
• Authors: Vandermeulen, Corinne; Theeten, Heidi; Rathi, Niraj; Kuriyakose, Sherine; Han, Htay Htay; Sokal, Etienne; Hoppenbrouwers, Karel; Van Damme, Pierre
• Is Part Of: Vaccine. Volume 33:Issue 26(2015)
• Page Start: 3026
• Page End: 3034
• Publication Date: 2015-06-12
• Subjects: Booster -- Vaccine -- Immunogenicity -- Safety -- Tdpa -- acellular pertussis vaccine -- Antibody persistence -- Aluminium; AE adverse event -- ATP according to protocol -- BR booster response -- CI confidence interval -- DT diphtheria toxoid -- dTpa reduced antigen content diphtheria-tetanus-acellular pertussis vaccine -- ELISA enzyme-linked immunosorbent assays -- FHA filamentous haemagglutinin -- GMC geometric mean antibody concentration -- PRN pertactin -- PT pertussis toxoid -- SAE serious adverse event -- TT tetanus toxoid; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2014.10.049
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Decennial booster vaccination with dTpa was immunogenic and well tolerated. Both dTpa vaccines (0.3 mg or 0.5 mg aluminium) were immunogenic. Reactogenicity of the 0.3 mg or 0.5 mg vaccines appeared similar. Increased aluminium appears to be associated with an increased anti-PT GMC. Either formulation could be confidently used as a decennial booster. Abstract: Background: Regular booster vaccination might be necessary throughout life to protect against pertussis infection. Nevertheless the duration of protection after booster vaccination remains unclear. In this study, antibody persistence up to 10 years after previous vaccination of adolescents ( N = 478) with combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (dTpa, Boostrix ™, GlaxoSmithKline Belgium) containing 0.5 mg, 0.3 mg or 0.133 mg of aluminium was assessed. The immunogenicity, reactogenicity and safety of a decennial booster dTpa dose were also investigated. Methods: Young adults vaccinated as adolescents in the initial booster study were invited to participate in an assessment of antibody persistence at years 8.5 and 10, and to receive a dTpa booster dose at year 10 with immunogenicity assessment one month later. Those who originally received the 0.5 mg or 0.3 mg formulations received the same vaccine at year 10. Those in the 0.133 mg group received the 0.5 mg formulation. Reactogenicity and safety endpoints were captured until 30 days after booster vaccination. Results: Prior to the decennial booster at year 8.5 and year 10, all participants had seroprotective antibodies for diphtheria (ELISA or neutralisation assay) and tetanus. At least 77.8% were seropositive for anti-pertussis toxin (PT) antibodies at year 8.5 and 82.8% at year 10. All participants were seropositive for antibodies for filamentous haemagglutinin and pertactin at both time points. The decennial booster dose induced robust increases in antibody GMCs to all antigens. The post-booster anti-PT geometric mean concentration was 82.5 EL.U/ml (95%CI 67.0–101.6) and 124.0 (103.5–148.5) in the 0.3 mg and 0.5 mg groups, respectively. The reactogenicity and safety profile of the decennial booster dose was consistent with the known safety profile of dTpa. No serious adverse events were reported. Conclusions: Decennial booster vaccination with either of the two licensed formulations of dTpa was highly immunogenic and well tolerated in young adults. Either formulation could be confidently used as a decennial booster. This study is registered atwww.clinicaltrials.gov NCT01147900