A study to evaluate the safety of ADX-038 in patients with complement-mediated kidney disease
RecruitingA study to evaluate the safety of ADX-038 in patients with complement-mediated kidney disease
- Participants:Adults
Rare diseases
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Poliovirus (inactivated) type 1 (Mahoney strain) is an inactivated (killed) poliovirus used as an antigen in vaccines. It is one of three poliovirus strains — type 1 (Mahoney), type 2 (MEF-1), and type 3 (Saukett) — that together provide protection against poliomyelitis. In the registry records, it appears only as part of fixed combination products, meaning it is not used alone but alongside diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b antigens.[3][1][2]
The substance is already authorised as a medicine in several forms. The authorisation holder is Sanofi Pasteur Europe.[3][1][2] The European Medicines Agency granted a product-specific waiver for a paediatric investigation plan for this combination of antigens in December 2021.[5]
The inactivated poliovirus type 1 (Mahoney strain) works by presenting killed virus particles to the immune system. Because the virus is inactivated, it cannot cause polio, but it still triggers the body to produce antibodies against poliovirus type 1. When a vaccinated person later encounters the live virus, these antibodies can neutralise it before it causes disease. This is the same principle used for the type 2 (MEF-1) and type 3 (Saukett) strains included in the same combination vaccines.[3][1]
The substance is given as a suspension for injection. The route of administration is intramuscular, typically as a 0.5 ml dose. In the trials, it is always part of a combination vaccine such as Tetravac, REPEVAX, Hexyon, or Infanrix hexa, never as a standalone injection.[1]–[4]
Four clinical trial records include this substance. In two trials it is a test component (Tetravac and REPEVAX in pertussis studies), and in one trial it is an auxiliary component (Infanrix hexa in a study of ADX-038).[3][1][4]
In the first pertussis trial (2024-510787-23-00), Tetravac was used to assess long-term pertussis immunity in 138 children whose mothers were vaccinated during pregnancy.[3] The second pertussis trial (2023-508416-35-00) compared REPEVAX with REVAXIS in 99 healthy adults to see whether booster vaccination reduces colonisation with Bordetella pertussis after controlled human infection.[1] The meningococcal trial (2023-510465-10-00) used Hexyon as a comparator in 750 children, toddlers, and infants.[2] The ADX-038 trial (NCT06989359) used Infanrix hexa as an auxiliary vaccine in 45 participants with complement-mediated kidney disease.[4]
The provided supplementary source does not list specific side effects for this poliovirus component. Side effect information for the authorised combination vaccines containing it is available in the product information for each vaccine, but those details are not included in the source data for this page.[5]
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