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Pertussis pertactin adsorbed on aluminium hydroxide, hydrated is a purified protein derived from Bordetella pertussis, the bacterium that causes whooping cough (pertussis). It is one of several inactivated components used in acellular pertussis vaccines, which are designed to protect against whooping cough without using whole bacterial cells.[5] In the registry records for the trials listed on this page, pertussis pertactin appears as part of Infanrix hexa, a combination vaccine that also contains diphtheria, tetanus, hepatitis B, poliomyelitis and Haemophilus influenzae type b components.[3]
Infanrix hexa is authorised as a medicine in the European Union under authorisation record EU/1/00/152/001, with GlaxoSmithKline Biologicals S.A. as the authorisation holder.[1] The substance is part of a fixed combination product and is available in a paediatric formulation.[1]
Pertactin is believed to help Bordetella pertussis bind to cells lining the respiratory tract and to resist clearance by immune cells called neutrophils, which affects how the bacterium spreads and how severe the disease becomes.[5] When pertactin is included in a vaccine, the immune system learns to recognise this protein and can mount a response against it. This is part of the broader immune training provided by acellular pertussis vaccines, which contain multiple inactivated components of the bacterium rather than whole cells.[5]
In recent years, surveillance studies have observed an increase in circulating Bordetella pertussis strains that do not produce pertactin (pertactin-deficient or PRN- strains), raising questions about how these strains behave and how well current vaccines continue to protect.[6][5]
Pertussis pertactin, as part of Infanrix hexa, is authorised for immunisation against several infectious diseases. The registry data list the following conditions in connection with the trials on this page:
In all four trials, Infanrix hexa serves an auxiliary or placebo role rather than being the substance under investigation.[1]–[4]
Pertussis pertactin is given as part of Infanrix hexa, which is a powder and suspension for suspension for injection. The route of administration is intramuscular injection.[3] The product is authorised for use in children, and a paediatric formulation exists.[1]
The four trials listed here do not investigate pertussis pertactin itself. Instead, Infanrix hexa — the combination vaccine containing pertussis pertactin — appears as an auxiliary or placebo intervention alongside the medicines being studied.[1]–[4]
One trial is a completed Phase 1 study of meningococcal vaccines that enrolled 703 participants.[3] A second trial is a Phase 1b/2 study of IM-101 in myasthenia gravis with 135 participants, currently authorised.[1] A third is a Phase 1/2 gene therapy study in HIGM1 with 6 participants, also authorised.[2] The fourth is a Phase 2 study of ADX-038 in complement-mediated kidney disease with 45 participants, authorised.[4]
The meningococcal vaccine trial measured safety and reactogenicity, including solicited administration site and systemic events during the 7 days after each vaccination, unsolicited adverse events during 30 days after vaccination, and immune responses measured by human serum bactericidal assay titres against meningococcal serogroups A, C, W, Y and B indicator strains.[3] The IM-101 trial measured treatment-emergent adverse events, serious adverse events, and changes in myasthenia gravis scores from baseline to Week 16.[1] The HIGM1 trial measured the proportion of patients experiencing dose-limiting toxicities after each dose.[2] The ADX-038 trial measured the incidence and severity of treatment-emergent adverse events.[4]
The supplementary sources provided do not include a side-effect profile for pertussis pertactin or Infanrix hexa. The trial records describe safety assessments but do not report results in the data provided.
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