Methods and compositions to inhibit adverse effects associated with vaccinations
Inventors
Iversen, Jacqueline M. • Dahl, Thomas A.
Assignees
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Publication Number
US-10874653-B2
Publication Date
2020-12-29
Expiration Date
Abstract
The invention relates to methods of inhibiting side effects associated with vaccination in a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject before the subject is vaccinated, wherein the pharmaceutical composition comprises: a) a non-steroidal anti-inflammatory drug (NSAID); and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine and cetirizine and combinations thereof.
Core Innovation
The invention relates to methods of inhibiting side effects associated with vaccination in a human subject in need thereof. The methods include administering an effective amount of a pharmaceutical composition before the subject is vaccinated or within about 48 hours after the subject is vaccinated, such that the vaccination-associated side effects are inhibited in the human subject. The pharmaceutical composition comprises a non-steroidal anti-inflammatory drug (NSAID) and a co-agent selected from fexofenadine, ketotifen, desloratadine, and cetirizine, and combinations thereof.
The disclosed compositions include NSAIDs and co-agents that are selected as combinations for inhibiting vaccination side effects. The partial content further identifies example NSAIDs such as aspirin, ibuprofen, naproxen, and salts, and it identifies example co-agents such as fexofenadine and the other enumerated co-agents, including salts, stereoisomers, and polymorphs. The disclosed approach is described in terms of inhibiting target adverse effects including injection site soreness, redness or swelling, and flu-like symptoms such as fever, headache, and muscle or joint pain, as well as congestion and cough.
The partial content states that the invention addresses concerns regarding vaccine efficacy and includes discussion of unexpected synergistic effects. Example results are described using an influenza-vaccine setting with a naproxen/fexofenadine combination (JMI-001), reporting low injection-site pain and absence of flu-like symptoms in multiple subjects. Additional example use cases are described in connection with a multi-vaccine travel context.
Claims Coverage
The provided independent claims cover three distinct method types: pre-vaccination inhibition, an influenza-specific quantitative pre-vaccination regimen, and post-vaccination (within about 48 hours) inhibition. Across these independent claims, the core inventive features are the use of an effective amount of an NSAID plus a co-agent selected from a defined group, together with vaccination-relative timing and, for one claim, quantitative dosage ranges and an influenza vaccine limitation.
Pre-vaccination NSAID and co-agent to inhibit vaccination side effects
Administering an effective amount of a pharmaceutical composition before the subject is vaccinated, wherein the pharmaceutical composition comprises an NSAID and a co-agent selected from the group consisting of fexofenadine, ketotifen, desloratadine, and cetirizine and combinations thereof, wherein the side effects associated with the vaccination are inhibited.
Essential naproxen sodium and fexofenadine prior to influenza vaccine
Administering to the subject an effective amount of a pharmaceutical composition prior to administration of an influenza vaccine, wherein the pharmaceutical composition consists essentially of about 220 mg to about 880 mg of naproxen sodium and about 60 mg to about 180 mg fexofenadine, wherein the side effects associated with the administration of an influenza vaccine are inhibited.
Post-vaccination NSAID and co-agent within about 48 hours
Administering an effective amount of a pharmaceutical composition within about 48 after the subject is vaccinated, wherein the pharmaceutical composition comprises an NSAID and a co-agent selected from the group consisting of fexofenadine, ketotifen, desloratadine, cetirizine and combinations thereof, wherein the side effects associated with the vaccination are inhibited.
Overall, the independent claims cover inhibiting vaccination-associated side effects by administering an NSAID together with a co-agent from a defined antihistamine group, either before vaccination, with an influenza-specific formulation consisting essentially of naproxen sodium and fexofenadine within stated ranges, or within about 48 hours after vaccination.
Stated Advantages
Inhibiting side effects associated with vaccination in a human subject.
Inhibiting side effects associated with administration of an influenza vaccine.
Documented Applications
Influenza-vaccine use case demonstrating inhibition of vaccination side effects, including low injection-site pain and absence of flu-like symptoms in multiple subjects using a naproxen/fexofenadine combination (JMI-001).
Multi-vaccine travel example use case described in the partial content.
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