Adjuvant-Sparing Multi-Dose Influenza Vaccination Regimen

Abstract

An influenza vaccine is administered by a multi-dose regimen, in which (i) a first dose is administered with an adjuvant and (ii) a later dose is administered either without an adjuvant or with a different adjuvant. Thus the invention provides the benefits of a two-dose regimen without also doubling the supply need for a given adjuvant.

Description

[0001]All documents cited herein are incorporated by reference in their entirety.TECHNICAL FIELD[0002]This invention is in the field of vaccines for protecting against influenza virus infection.BACKGROUND ART[0003]Patients receiving influenza vaccines are currently given one dose every year, except that the first time that the vaccine is given to a child aged 8 years or below they receive two doses separated by at least four weeks.[0004]It is thought (e.g. see ref. 1) that a two-dose regimen will also be required in a pandemic situation, where the human population is immunologically naïve to a new influenza virus strain.[0005]The need for two doses means that, with a fixed supply of antigen, the number of doses that can be made is half of the number that could be made with a one-dose regimen. Thus it has been proposed to use a lower amount of antigen per dose, and to use an adjuvant to compensate for this reduction.[0006]If a one-dose regimen of an adjuvanted vaccine does not elicit...

AI Technical Summary

Benefits of technology

[0029]To reduce the number of plasmids needed, a recent approach [24] combines a plurality of RNA polymerase I transcription cassettes (for viral RNA synthesis) on the same plasmid (e.g. sequences encoding 1, 2, 3, 4, 5, 6, 7 or all 8 influenza A vRNA segments), and a plurality of protein-coding regions with RNA polymerase II promoters on another plasmid (e.g. sequences encoding 1, 2, 3, 4, 5, 6, 7 or all 8 influenza A mRNA transcripts). Preferred aspects of the reference 24 method involve: (a) PB1, PB2 and PA mRNA-encoding regions on a single plasmid; and (b) all 8 vRNA-encoding segments on a single plasmid. Including the NA and HA segments on one plasmid and the six other segments on another plasmid can also facilitate matters.

[0191]Where a composition / component is packaged into a syringe, the syringe may have a needle attached to it. If a needle is not attached, a separate needle may be supplied with the syringe for assembly and use. Such a needle may be sheathed. Safety needles are preferred. 1-inch 23-gauge, 1-inch 25-gauge and ⅝-inch 25-gauge needles are typical. Syringes may be provided with peel-off labels on which the lot number, influenza season and expiration date of the contents may be printed, to facilitate record keeping. The plunger in the syringe preferably has a stopper to prevent the plunger from being accidentally removed during aspiration. The syringes may have a latex rubber cap and / or plunger. Disposable syringes contain a single dose of vaccine. The syringe will generally have a tip cap to seal the tip prior to attachment of a needle, and the tip cap is preferably made of a butyl rubber. If the syringe and needle are packaged separately then the needle is preferably fitted with a butyl rubber shield. Preferred syringes are those marketed under the trade name “Tip-Lok”™.

Problems solved by technology

If a one-dose regimen of an adjuvanted vaccine does not elicit a sufficient immune response, however, then a two-dose regimen will be required anyway, with the additional disadvantage that the supply of adequate amounts of adjuvant will also then be an issue.

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