Biological Therapeutics for Infection-Relating Disorders or Conditions

Abstract

The present invention discloses products and the methods of uses of the products for preventing and treating infectious diseases and the disorders or conditions inducible by harmful antibodies. The harmful antibodies are induced during infection, or vaccination, or use of therapeutic antibodies. The products of the present disclosure comprise immunoglobulin products, serum or plasma, specific antibodies to viral pathogens.

Claims

1: A therapeutic product for treating and preventing an infection caused by a viral pathogen or a disease or condition caused by a harmful antibody, comprising: (a) an N-acetylneuraminic acid; and (b) at least one of a specific antibody to a viral pathogen, an immunoglobulin, and serum or plasma, wherein the harmful antibody is induced by an infection, a vaccination, or a passively introduced therapeutic antibody, wherein the disease or condition caused by the harmful antibody comprises an infectious disease, a serious adverse reaction to a vaccine or a therapeutic antibody, an infection-related autoimmune disease, an allergy, inflammation, or an infection-related tumor, and wherein the immunoglobulin, serum, or plasma is obtained from a healthy individual.

2: The therapeutic product of claim 1, wherein the viral pathogen is an influenza virus, a hepatitis C virus, a hepatitis B virus, a respiratory syncytial virus, an adenovirus, or a rotavirus.

3: The therapeutic product of claim 1, wherein the serious adverse reaction is Guillain-Barre syndrome-like condition, death, abortion, immature or delayed delivery, fetal death, or neonatal death.

4: The therapeutic product of claim 1, wherein the infection is an influenza infection and the vaccination is influenza vaccination.

5: The therapeutic product of claim 1, wherein the product comprises about 0.001 g to about 100 g of immunoglobulin or about 0.1 mL to 1000 mL of serum or plasma.

6: The therapeutic product of claim 1, wherein the product comprises about 0.01 mg to 500 mg of a specific antibody to a viral pathogen and about 0.001 g to about 100 g of immunoglobulin, or about 0.1 mL to 1000 mL of serum or plasma.

7: The therapeutic product of claim 1, wherein the product comprises about 0.1 mg/mL to about 20 mg/mL or about 0.1 mg/g to about 20 mg/g of N-acetylneuraminic acid and about 0.001 g to about 100 g of immunoglobulin, or about 0.01 mg to 500 mg of a specific antibody to a viral pathogen, or about 0.1 mL to about 1000 mL of serum or plasma.

8: The therapeutic product of claim 1, wherein the product is a solution, lyophilized, an injectable, an infusion, or a form conjugated to a nano-particle.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0169] FIG. 1 is a graphical representation of histology changes of lungs from the mouse pups delivered to the dams treated with human serum of healthy individuals (A) or the anti-09HIN1influenza virus serum (B). This data showed that antibodies induced by the 09H 1N 1 influenza vims are harmful to fetuses and newborns since it caused later fetal death (still birth) and neonatal death.

ADDITIONAL EMBODIMENTS

[0170] Another embodiment of the present invention discloses therapeutic products comprising a vaccine or an inactivated pathogen for the treatment of a severe infection caused by antibodies induced during an infection; wherein the therapeutic vaccines or inactivated pathogens neutralize harmful antibodies induced during the infection.

[0171] Another embodiment of the present invention discloses a method of administrating a therapeutic vaccine or an inactivated pathogen to a patient to prevent or treat the disorders or conditions caused by the antibodies against the vaccine or the pathogen; wherein the antibodies are induced during an infection; the therapeutic vaccines or inactivated pathogens neutralize harmful antibodies induced during the infection.

[0172] Other embodiments besides the above may be articulated as well. The terms and expressions therefore serve only to describe the disclosure by example only and not to limit the disclosure. It is expected that others will perceive differences, which while differing from the foregoing, do not depart from the spirit and scope of the disclosure herein described and claimed. All patents, patent publications, and other references cited herein are incorporated herein by reference in their entirety.