The PertADO Geneva Trial

Summary

This is a phase II, randomized double-center, and observer-blind controlled pilot vaccine trial in 11 to 15 years old healthy subjects to assess the immunogenicity of the genetically detoxified pertussis toxin (rPT) included in a novel acellular pertussis vaccine (Pertagen®) manufactured by BioNet-Asia when delivered by the intramuscular route to adolescents previously primed and boosted with chemically-detoxified PT, along with Td-pur® and in comparison with that of Boostrix® dTpa. At Day 0, eligible volunteers will undergo a venous bleed for the determination of baseline values and enter the randomization scheme, being allocated to one of two groups: A (Pertagen® + Td-pur®), B (Boostrix® dTpa). Randomized participants will receive one dose of Pertagen® and Td-pur® (Group A) or 1 dose of Boostrix® dTpa (Group B) by intramuscular injection in the deltoid. All subjects will be observed in the Plateforme de Recherché Pédiatrique for 30 minutes after immunization. Post-immunization local and systemic reactions will be followed up for 7 days after immunization. Adverse events will be followed for 28 days after immunization. At Day 28, a second visit (study end visit) will take place for safety evaluation and blood draw for immunogenicity evaluation. Blood draws performed on Day 0 (Baseline) and Day 28 will be used to evaluate immune response to study vaccines. The primary statistical analysis will be performed with visit 2 (Day 28) data to compare the immunogenicity and safety of one dose of Pertagen®, given simultaneously with Td-pur®, to those elicited by Boostrix® dTpa.

Timeline

Start

2016-10-27

Primary completion

2017-03-09

Completion

2017-03-09

Publications

• Background Buasri W, Impoolsup A, Boonchird C, Luengchaichawange A, Prompiboon P, Petre J, Panbangred W. Construction of Bordetella pertussis strains with enhanced production of genetically-inactivated Pertussis Toxin and Pertactin by unmarked allelic exchange. BMC Microbiol. 2012 Apr 23;12:61. doi: 10.1186/1471-2180-12-61.
• Background Ibsen PH. The effect of formaldehyde, hydrogen peroxide and genetic detoxification of pertussis toxin on epitope recognition by murine monoclonal antibodies. Vaccine. 1996 Apr;14(5):359-68. doi: 10.1016/0264-410x(95)00230-x.
• Background Podda A, Carapella De Luca E, Titone L, Casadei AM, Cascio A, Bartalini M, Volpini G, Peppoloni S, Marsili I, Nencioni L, et al. Immunogenicity of an acellular pertussis vaccine composed of genetically inactivated pertussis toxin combined with filamentous hemagglutinin and pertactin in infants and children. J Pediatr. 1993 Jul;123(1):81-4. doi: 10.1016/s0022-3476(05)81543-4.
• Background Rappuoli R. The vaccine containing recombinant pertussis toxin induces early and long-lasting protection. Biologicals. 1999 Jun;27(2):99-102. doi: 10.1006/biol.1999.0189.
• Background Salmaso S, Mastrantonio P, Tozzi AE, Stefanelli P, Anemona A, Ciofi degli Atti ML, Giammanco A; Stage III Working Group. Sustained efficacy during the first 6 years of life of 3-component acellular pertussis vaccines administered in infancy: the Italian experience. Pediatrics. 2001 Nov;108(5):E81. doi: 10.1542/peds.108.5.e81.
• Blanchard Rohner G, Chatzis O, Chinwangso P, Rohr M, Grillet S, Salomon C, Lemaitre B, Boonrak P, Lawpoolsri S, Clutterbuck E, Poredi IK, Wijagkanalan W, Spiegel J, Pham HT, Viviani S, Siegrist CA. Boosting Teenagers With Acellular Pertussis Vaccines Containing Recombinant or Chemically Inactivated Pertussis Toxin: A Randomized Clinical Trial. Clin Infect Dis. 2019 Mar 19;68(7):1213-1222. doi: 10.1093/cid/ciy594.

Drugs

Indications