Combination vaccines with lower doses of antigen and/or adjuvant

Abstract

Combination vaccine compositions as well as methods for their manufacture have a relatively low amount of antigen and / or a relatively low amount of aluminium, but they can nevertheless have immunogenicity which is comparable to combination vaccines with a relatively high amount of antigen and / or a relatively high amount of aluminium. Aluminium-free combination vaccine compositions are also provided e.g. compositions which are adjuvanted with an oil-in-water emulsion adjuvant.

Description

TECHNICAL FIELD[0001]This invention is in the field of combination vaccines i.e. vaccines containing mixed immunogens from more than one pathogen, such that administration of the vaccine can simultaneously immunize a subject against more than one pathogen.BACKGROUND ART[0002]Vaccines containing antigens from more than one pathogenic organism within a single dose are known as “multivalent” or “combination” vaccines. Various combination vaccines have been approved for human use in the EU and the USA, including trivalent vaccines for protecting against diphtheria, tetanus and pertussis (“DTP” vaccines) and trivalent vaccines for protecting against measles, mumps and rubella (“MMR” vaccines). Combination vaccines offer patients the advantage of receiving a reduced number of injections, which can lead to the clinical advantage of increased compliance (e.g. see chapter 29 of reference 1), particularly for pediatric vaccination.[0003]Current combination vaccines can include relatively high...

AI Technical Summary

Benefits of technology

The patent text discusses the use of international units (IU) for measuring the amount of tetanus toxoid in a composition. The text also describes a new immunisation schedule for infants that only requires one or two doses of a DTP-containing composition, instead of the current three-dose schedule. The invention aims to deliver fewer doses while still maintaining the protective effect of immunisation.

Problems solved by technology

Another drawback with current vaccines is that they require relatively high amounts of antigen, whereas various documents show that protective effects might be achieved with lower amounts of antigen e.g. reference 4 shows that the amount of Hib antigen can be halved in a D-T-Pw-Hib vaccine without loss of immunological response, and reference 5 argues that a reduced IPV dose can be used while maintaining an adequate level of protection against polio.

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