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Pharmacology: Pharmacodynamics: Immune response: Immunogenicity of Pertagen and Td-Pertagen was evaluated in six randomized controlled trials including 378 persons ranging in age from 3 to 75 years old (20 children, 179 adolescents, 179 adults including 39 pregnant women and 15 older adults).
In the absence of a licensed monovalent pertussis comparator, Pertagen was compared to different licensed combined vaccines in its monovalent formulation and combined to Td (Td-Pertagen).
In all conducted randomized controlled trials, Pertagen was found to be more immunogenic than Tdapchem comparator vaccines with significantly higher PT-IgG titers one month after vaccination. The summary of five of these trials is provided in Table 1.
Two of these trials were non-inferior studies that showed non-inferiority of Pertagen compared to licensed vaccines as per EMA guidelines (CPMP/EWP/2158/99). In addition, superiority of Pertagen can be claimed based on pertussis seroconversion rates as per EMA guidelines (CPMP/EWP/482/99).
One trial in children found that Td-Pertagen was immunogenic when compared to pediatric DTaPchem containing vaccine. (See Table 1.)
Click on icon to see table/diagram/imageAntibody persistence: Long-term antibody persistence was shown in adolescents five years after vaccination with Pertagen with 75% of vaccinees retaining high PT-IgG levels (≥20 IU/mL), as opposed to 27% of vaccinees that received a licensed vaccine. (See Table 2.)
Click on icon to see table/diagram/imagePassive protection against pertussis in infants born to mother vaccinated during pregnancy: Pertagen and Td-Pertagen were evaluated in pregnant women in three studies (Table 1 and 3) and compared to two different Tdapchem comparator vaccines and a control Td vaccine: Pertagen induced significantly higher PT-neutralizing antibody (PTNA) titers and PT-IgG and FHA-IgG antibody concentrations than a comparator Tdapchem vaccine in pregnant women one-month post vaccination.
Td-Pertagen induced PT-IgG antibody concentrations non-inferior to a comparator Tdapchem vaccine in pregnant and non-pregnant women.
Pertagen (and Td-Pertagen) induced maternal pertussis antibodies that were effectively transferred at high levels to infants and remained high in infants until at least 2 months after birth (Table 3).
There were no significant differences in pertussis antibody responses between Pertagen and Td-Pertagen between non-pregnant and pregnant women, or between vaccination in the second or third trimester of gestation. (See Table 3.)
Click on icon to see table/diagram/imageMaternal pertussis immunization may interfere with infants' immune response to primary pertussis immunization. However, no evidence suggests a clinical impact of such immunological interference on protection against pertussis.
Immune response in immunocompromised population: Maternal immunization with Td-Pertagen resulted in comparable high PT-IgG antibody concentrations in infants born to HIV-infected or non-infected pregnant women.
Protection against Pertussis: Immunological correlates of protection against pertussis are not well-defined, but higher levels of anti-pertussis antibodies are associated with greater protection. Present knowledge indicates that PT, particularly if genetically detoxified, represents the main antigen that protects against severe pertussis disease.
Pertagen induces significantly higher anti-PT antibody titers than licensed Tdapchem vaccines for which effectiveness is documented.
Pertagen-induced anti-PT antibody titers are significantly higher and persist at significantly higher levels for at least five years, conferring higher and longer duration of protection than licensed Tdapchem vaccine.
Maternal vaccination is a highly effective strategy to protect infants against pertussis infection through both transfer of maternal pertussis antibodies and reduced infant exposure to pertussis.
Vaccination of pregnant women with Pertagen induces high titers of PT-neutralizing antibodies that are effectively transferred to their infants.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical safety data: General toxicity: Preclinical data of Pertagen and Td-Pertagen reveal no special hazard for humans based on conventional studies of single-dose toxicity and repeat-dose toxicity in rats.
Genotoxicity/Carcinogenicity: Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine are not expected to have genotoxic potential.
Reproductive and Developmental toxicity: Two prenatal and postnatal developmental toxicity studies of Td-Pertagen show no toxicity effect on maternal pregnancy, parturition, lactation, embryo-foetal development and reproductive performance in rats.
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