Combination vaccines with lower doses of antigen and/or adjuvant

a vaccine and vaccine technology, applied in the field of conjugated vaccines, can solve the problem of requiring relatively high amounts of antigen, and achieve the effect of fewer doses and without loss of immunoprotective

Inactive Publication Date: 2014-04-24
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0168]As mentioned above, a further aspect of the invention is an immunisation schedule for an infant (i.e. a child between birth and 1 year of age) in which only one or two DTP-containin

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

Method used

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  • Combination vaccines with lower doses of antigen and/or adjuvant
  • Combination vaccines with lower doses of antigen and/or adjuvant
  • Combination vaccines with lower doses of antigen and/or adjuvant

Examples

Experimental program
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Embodiment Construction

Adjuvant Adsorption to Antigens

[0196]3-valent (DTaP) or 6-valent (DTaP-HBsAg-IPV-Hib) vaccines were adjuvanted with aluminium hydroxide alone, aluminium hydroxide with pre-adsorbed ‘compound T’, poly(lactide-co-glycolide) microparticles (‘PLG’), and MF59 oil-in-water emulsion. Aluminium hydroxide and aluminium hydroxide with pre-adsorbed ‘compound T’ were prepared in histidine buffer pH 6.5. At pH 6.5, aluminium hydroxide has a positive net charge, while most proteins have a negative net charge. The pH value was chosen to provide good adsorption of most of the tested antigens. All formulations adjuvanted with aluminium hydroxide or aluminium hydroxide with pre-adsorbed ‘compound T’ showed optimal pH (6.5-6.8±0.1) and osmolarity values (0.300±50 mO). Osmolarity was adjusted with NaCl. Antigens for the MF59-adjuvanted formulations were prepared in PBS. The resulting preparations had pH values between 6.2 and 7.3 and osmolarity values around 0.300±50 mO. Formulations containing PLG mic...

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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...

Claims

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Application Information

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IPC IPC(8): A61K39/00
CPCA61K39/0018A61K31/4375A61K31/66A61K33/06A61K39/39A61K2039/545A61K2039/55505A61K2039/55555A61K2039/55566A61K2039/70C12N2730/10134C12N2770/32634A61K39/102A61K39/12A61P31/04A61P31/12Y02A50/30A61K2300/00A61K39/116A61K39/295A61K39/095A61K39/13
Inventor SINGH, MANMOHANBAUDNER, BARBARASKIBINSKI, DAVID
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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