Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial

Noris Pavia-Ruz, Katia Abarca, Alejandro Lepetic, Maria Yolanda Cervantes-Apolinar, Karin Hardt, Girish Jayadeva, Sherine Kuriyakose, Htay Htay Han, Manuel de la O, Noris Pavia-Ruz, Katia Abarca, Alejandro Lepetic, Maria Yolanda Cervantes-Apolinar, Karin Hardt, Girish Jayadeva, Sherine Kuriyakose, Htay Htay Han, Manuel de la O

Abstract

Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10-15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine.

Trial registration: ClinicalTrials.gov NCT01362322.

Keywords: ANCOVA, analysis of co-variance; ATP, according to protocol; CI, confidence interval; El.U, Elisa units; FHA, filamentous hemagglutinin; GI, gastrointestinal; GMC, geometric mean concentration; IU, international units; LL, lower limit; PRN, pertactin; PT, pertussis toxin; SAE, serious adverse event; TVC, total vaccinated cohort; UL, upper limit; booster; dTpa, reduced-antigen-content diphtheria tetanus and acellular pertussis vaccine; diphtheria; pertussis; syringe presentation; tetanus.

Figures

Figure 1.
Figure 1.
Incidence of solicited local and general symptoms reported during the 4-day post-vaccination follow-up period (Total Vaccinated Cohort).

References

    1. Gabutti G, Rota MC. Pertussis: a review of disease epidemiology worldwide and in Italy. Int J Environ Res Public Health 2012; 9:4626-38; PMID:23330226;
    1. Guiso N, Wirsing von Konig CH, Forsyth K, Tan T, Plotkin SA. The Global Pertussis Initiative: report from a round table meeting to discuss the epidemiology and detection of pertussis, Paris, France, 11–12 January 2010. Vaccine 2011; 29:1115-21; PMID:21168525;
    1. Wendelboe AM, Van Rie A, Salmaso S, Englund JA. Duration of immunity against pertussis after natural infection or vaccination. Pediatr Infect Dis J 2005; 24:S58-61; PMID:15876927;
    1. McCormack PL. Reduced-antigen, combined diphtheria, tetanus and acellular pertussis vaccine, adsorbed (Boostrix(R)): a review of its properties and use as a single-dose booster immunization. Drugs 2012; 72:1765-91; PMID:22931522;
    1. Scott LJ, McCormack PL. Reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine, adsorbed (boostrix((R))): a guide to its use as a single-dose booster immunization against pertussis. BioDrugs 2013; 27:75-81; PMID:23329401;
    1. Mertsola J, Van Der Meeren O, He Q, Linko-Parvinen A, Ramakrishnan G, Mannermaa L, Soila M, Pulkkinen M, Jacquet JM. Decennial administration of a reduced antigen content diphtheria and tetanus toxoids and acellular pertussis vaccine in young adults. Clin Infect Dis 2010; 51:656-62; PMID:20704493;
    1. Van Damme P, McIntyre P, Grimprel E, Kuriyakose S, Jacquet JM, Hardt K, Messier M, Van Der Meeren O. Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix((R))) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine 2011; 29:5932-9; PMID:21718738;
    1. Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine 2012; 30:1721-8; PMID:22212127;
    1. Abarca K, Valdivieso F, Potin M, Ibanez I, Vial P. [Immunogenicity and reactogenicity of a reduced antigen content diphtheria, tetanus and acellular pertussis vaccine dTpa) in 10 to 11 years old children and in adults]. Rev Med Chile 2002; 130:502-10; PMID:12143270;
    1. Kosuwon P, Warachit B, Hutagalung Y, Borkird T, Kosalaraksa P, Bock HL, Poovorawan Y. Reactogenicity and immunogenicity of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (dTpa) administered as a booster to 4-6 year-old children primed with four doses of whole-cell pertussis vaccine. Vaccine 2003; 21:4194-200; PMID:14505898;
    1. Huang LM, Chang LY, Tang H, Bock HL, Lu CY, Huang FY, Lin TY, Lee CY. Immunogenicity and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in healthy Taiwanese children and adolescents. J Adolesc Health 2005; 37:517; PMID:16310132;
    1. Pichichero ME, Blatter MM, Kennedy WA, Hedrick J, Descamps D, Friedland LR. Acellular pertussis vaccine booster combined with diphtheria and tetanus toxoids for adolescents. Pediatrics 2006; 117:1084-93; PMID:16585302;
    1. Knuf M, Zepp F, Meyer C, Grzegowski E, Wolter J, Riffelmann M, Wirsing von König CH. Immunogenicity of a single dose of reduced-antigen acellular pertussis vaccine in a non-vaccinated adolescent population. Vaccine 2006; 24:2043-8; PMID:16356597;
    1. Booy R, Van der Meeren O, Ng SP, Celzo F, Ramakrishnan G, Jacquet JM. A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix) is immunogenic and well tolerated in adults. Vaccine 2010; 29:45-50; PMID:20974302;
    1. Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine 2009; 27:765-72; PMID:19041352;
    1. Bose A, Dubey AP, Gandhi D, Pandit A, Raghu MB, Raghupathy P, Rao MI, Verghese VP, Datta SK, Bock HL. Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school Indian children. Indian Pediatr 2007; 44:421-4; PMID:17620694
    1. Zepp F, Habermehl P, Knuf M, Mannhardt-Laakman W, Howe B, Friedland LR. Immunogenicity of reduced antigen content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. Vaccine 2007; 25:5248-52; PMID:17583395;
    1. Vergara R, Tregnaghi M, Ussher J, Navarro S, Rüttimann R, Potin M, Wolter J, Schuerman L. Reduced-antigen-content-diphtheria-tetanus-acellular-pertussis and inactivated polio vaccine as a booster for adolescents 10 to 14 years of age. Eur J Pediatr 2005; 164:377-82; PMID:15782295;
    1. Weston WM, Chandrashekar V, Friedland LR, Howe B. Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Human vaccines 2009; 5:858-66; PMID:19838080;
    1. Sanger R, Behre U, Krause KH, Loch HP, Soemantri P, Herrmann D, Schmitz-Hauss E, Wolter J, Hoet B. Booster vaccination and 1-year follow-up of 4-8-year-old children with a reduced-antigen-content dTpa-IPV vaccine. Eur J Pediatr 2007; 166:1229-36; PMID:17235521;

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