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US 2017/0304429 A1Published application
Vaccination of immunocompromised subjects
AssigneeSeqirus UK Limited
InventorsGiuseppe DEL GIUDICE, Rino RAPPUOLI, Steven BLACK, Uwe NICOLAY
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Abstract
Disclosed herein are methods for enhancing immune responses to a vaccine in immunocompromised individuals, including those receiving a statin therapy. Related products are also provided.
Claims27
1:
- A method for enhancing an immune response in a subject comprising administering a vaccine, wherein the vaccine comprises:
- (a) an adjuvant;
- (b) a high-dose antigen;
- or
- a combination of (a) and (b);
- and
- wherein the subject is under the age of 65 and on a statin therapy.
4 more elements
2:
- The method of claim 1, wherein the adjuvant is an aluminum salt adjuvant or an oil-in-water emulsion adjuvant.
3:
- The method of claim 2, wherein the oil-in-water emulsion adjuvant comprises squalene.
4:
- The method of claim 2, wherein the oil-in-water adjuvant comprises squalene, polysorbate 80, and sorbitan trioleate.
5:
- The method of claim 1, wherein the vaccine comprises between a ⅛ and a ten-fold the amount of a standard dose antigen.
6:
- The method of claim 1, wherein the vaccine is an influenza vaccine.
7:
- The method of claim 5, wherein the influenza vaccine comprises between about 30 μg and about 150 μg of antigen per strain.
8:
- The method of claim 6, wherein the influenza vaccine comprises an H1N1 strain, an H3N2 strain, a B strain, or any combination thereof.
9:
- The method of claim 1, wherein the vaccine does not contain an oil-in-water emulsion adjuvant.
10:
- The method of claim 1, wherein the subject is:
- a) currently on a statin therapy;
- b) not currently on a statin therapy but was on a statin therapy which terminated within the last 3 months;
- or
- c) not currently on a statin therapy but is scheduled to be on a statin therapy in the next 3 months.
2 more elements
11:
- The method of claim 1, wherein the subject is
- between the age of 60 and 64.
12:
- The method of claim 1, wherein the subject has a disease or disorder associated with impaired immunity.
13:
- The method of claim 1, wherein the statin therapy comprises a synthetic statin, a non-synthetic statin, or a combination thereof.
14:
- The method of claim 13, wherein the statin therapy comprises a synthetic statin selected from the group consisting of:
- Fluvastatin, Atorvastatin, Cerivastatin, Rosuvastatin and Pitavastatin.
15:
- The method of claim 3, wherein the oil-in-water emulsion adjuvant further comprises a surfactant.
16:
- The method of claim 4, wherein the oil-in-water adjuvant comprises about 4.3% squalene, about 0.5% polysorbate 80 and about 0.48% sorbitan trioleate by weight.
17:
- The method of claim 5, wherein the vaccine comprises between a two-fold and a ten-fold the amount of a standard dose antigen.
18:
- The method of claim 6, wherein the influenza vaccine is a multivalent influenza vaccine.
19:
- The method of claim 7, wherein the influenza vaccine comprises about 60 μg of antigen per strain.
20:
- The method of claim 6, wherein the influenza vaccine comprises between about 30 μg and about 150 μg of antigen per strain.
21:
- The method of claim 20, wherein the influenza vaccine comprises about 60 μg of antigen per strain.
22:
- The method of claim 7, wherein the influenza vaccine comprises an H1N1 strain, an H3N2 strain, a B strain, or any combination thereof.
23:
- The method of claim 10, wherein the subject has been on the statin therapy for at least 1 week.
24:
- The method of claim 23, wherein the subject has been on the statin therapy for at least 2 weeks.
25:
- The method of claim 24, wherein the subject has been on the statin therapy for at least 3 weeks.
26:
- The method of claim 25, wherein the subject has been on the statin therapy for at least 4 weeks or longer.
27:
- The method of claim 13, wherein the statin therapy comprises a statin selected from the group consisting of:
- Pravastatin, Simvastatin, Lovastatin and Mevastatin, Fluvastatin, Atorvastatin, Cerivastatin, Rosuvastatin and Pitavastatin.