pertagen Mechanism of Action

Pharmaco-therapeutic group: Bacterial vaccines. ATC code: J07AJ02.
Pharmacology: Pharmacodynamics: Immunogenicity of Pertagen was evaluated in 150 adolescents aged 12-27 years old and compared with a licensed Tdap vaccine to show non-inferiority (Committee for Medicinal Products for Human Use (CHMP) (2005) Guideline on the choice of the non-inferiority margin: EMEA/CPMP/EWP/2158/99).
At 28 days after vaccination, ELISA anti-PT and anti-FHA antibody titers and seroconversion rates were statistically significant higher in subjects vaccinated with Pertagen than in subjects vaccinated with the licensed Tdap vaccine. Non-inferiority of Pertagen was met. In addition, superiority of ELISA anti-PT and anti-FHA seroconversion rates and GMTs was demonstrated according to EMEA guidelines (Committee for Proprietary Medicinal Products (CPMP) (2000) Points to consider on switching between superiority and non-inferiority: CPMP/EWP/482/99). (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Protective efficacy of pertussis: No established correlates of protection to pertussis antigens are currently available. Although efficacy or effectiveness data of Pertagen are not available for adolescents and adults including pregnant women, non-inferiority of the immune response of Pertagen was demonstrated as per WHO recommendations (TRS 979, 2013) in adolescents in a comparative randomized controlled trial with a licensed Tdap vaccine evaluated in effectiveness study. The antibody titers to pertussis antigens, PT and FHA, after vaccination with Pertagen were statistically higher than those observed after immunization with the Tdap comparator vaccine. In addition, 1 month after booster vaccination, the neutralizing antibodies against PT antigen were also significantly higher with Pertagen than with the Tdap comparator vaccine.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical safety data: Preclinical data reveal no special hazard for humans based on conventional studies of safety and toxicity.