Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
C07K-016/12
C07K-016/06
A61K-009/00
A61K-035/16
출원번호
US-0460147
(2017-03-15)
등록번호
US-10259865
(2019-04-16)
발명자
/ 주소
Mond, James
Grossman, Adam S.
출원인 / 주소
ADMA Biologics, Inc.
대리인 / 주소
Jones, S.C., Casimir
인용정보
피인용 횟수 :
0인용 특허 :
83
초록▼
The present invention relates to compositions and methods for the treatment of infection caused by Streptococcus pneumonia. In particular, the invention provides human hyperimmune globulin and compositions thereof for preventing or treating pneumococcal infection. The invention provides methods of p
The present invention relates to compositions and methods for the treatment of infection caused by Streptococcus pneumonia. In particular, the invention provides human hyperimmune globulin and compositions thereof for preventing or treating pneumococcal infection. The invention provides methods of producing hyperimmune globulin containing high titers of opsonophagocytic anti-pneumococcal antibodies, compositions containing same, and methods of using the compositions for the prevention and treatment of pneumococcal infection. The invention further provides methods of preventing or treating pneumococcal infection (e.g., upper respiratory infections (e.g., bronchitis, otitis, sinusitis, etc.)) in immunocompromised subjects via administration of hyperimmune globulin compositions of the invention (e.g., containing a high titer of opsonophagocytic anti-pneumococcal antibodies) to immunocompromised subjects.
대표청구항▼
1. A method for preparing an immune globulin having elevated opsonophagocytic antibody titers for 50% or more Streptococcus pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F comprising the steps of: (a) immunizing healthy adult human plasma donors between
1. A method for preparing an immune globulin having elevated opsonophagocytic antibody titers for 50% or more Streptococcus pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F comprising the steps of: (a) immunizing healthy adult human plasma donors between the ages of 18-60 with a primary immunization with a multivalent S. pneumonia conjugate vaccine followed by a secondary immunization with a multivalent S. pneumonia polysaccharide vaccine;(b) harvesting plasma from the immunized plasma donors subsequent to the secondary immunization;(c) pooling the plasma harvested according to step (b) in order to obtain a pooled plasma containing elevated opsonophagocytic antibody titers specific for 50% or more S. pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, wherein each of the elevated opsonophagocytic antibody titers is three-fold or higher than the opsonophagocytic antibody titer specific for each S. pneumonia serotype present in a control sample, wherein the control sample is immune globulin prepared from plasma pooled from 500 or more random non-immunized human plasma donors; and(d) preparing immune globulin from the plasma pooled according to step (c). 2. The method of claim 1, further comprising the step (e) rendering the immune globulin obtained according to step (d) intravenously injectable. 3. The method of claim 2, wherein the immune globulin is provided in solution and the pH and ionic strength of the solution is adjusted so as to render it intravenously injectable. 4. An immune globulin prepared according to the method of claim 1. 5. A method of treating S. pneumonia infection in a subject comprising administering to the subject a therapeutically effective amount of an immune globulin prepared according to the method of claim 1. 6. A method of providing immunotherapy to a subject comprising administering to the subject a therapeutically effective amount of an immune globulin prepared according to the method of claim 1. 7. The method of claim 1, wherein the pooled plasma of step (c) contains elevated opsonophagocytic antibody titers specific for 50% or more S. pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F that are five-fold or higher than the opsonophagocytic antibody titer specific for each S. pneumonia serotype present in the control sample. 8. The method of claim 1, wherein the pooled plasma of step (c) contains elevated opsonophagocytic antibody titers specific for 50% or more S. pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F that are ten-fold or higher than the opsonophagocytic antibody titer specific for each S. pneumonia serotype present in the control sample.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (83)
Mochida Ei (Tokyo JPX) Ogawa Nobuhisa (Omiya JPX) Shinkai Hiroyuki (Kawagoe JPX) Kudo Takashi (Tokyo JPX), Agglutination inhibition immunoassay for hapten using two differently sensitized particles.
Aronson David L. (Bethesda MD) Tabor Edward (Bethesda MD) Gerety Robert J. (Bethesda MD), Hepatitis B immune globulin used to inactivate hepatitis B virus in injectable biological products.
Gurnett-Bander, Anne; Perez-Caballero, David; Sivapalasingam, Sumathi; Duan, Xunbao; MacDonald, Douglas, Human antibodies to respiratory syncytial virus F protein and methods of use thereof.
Burton, Dennis R.; Barbas, III, Carlos F.; Chanock, Robert M.; Murphy, Brian R.; Crowe, Jr., James E., Human neutralizing monoclonal antibodies to respiratory syncytial virus.
Chan Christina Y. ; Sadoff Jerald C., Immunization against Streptococcus pneumoniae using conjugated and unconjugated pneumoccocal polysaccharide vaccines.
Anderson Porter W. (Rochester NY) Eby Ronald J. (Rochester NY), Immunogenic conjugates of streptococcus pneumonial capsular polymer and toxin or in toxiad.
Prince Gregory (Bethesda MD) Chanock Robert (Bethesda MD) Hemming Val G. (Gaithersburg MD), Immunotherapeutic method of treating respiratory disease by intranasal administration of Igb.
Gristina Anthony G. (Reston VA) Myrvik Quentin N. (Caswell Beach NC), Method and compositions for the direct concentrated delivery of passive immunity.
Levy, Joshua; Rothstein, Fred; Shimiaei, Bahman, Method for high yield purification of immune globulins from blood plasma and blood plasma intermediates.
Gristina Anthony G. (11605 Deer Forest Rd. Reston VA 22094) Myrvik Quentin N. (404 Palmetto Dr. Caswell Beach NC 28465), Methods and compositions for the direct concentrated delivery of passive immunity.
Young, James F.; Koenig, Scott; Johnson, Leslie S.; Huse, William D.; Watkins, Jeffrey D.; Wu, Herren, Methods of administering/dosing anti-RSV antibodies for prophylaxis and treatment.
Pilkington, Glenn R.; Gilmour, Page S.; Chanock, Robert M.; Crowe, Jr., James E.; Murphy, Brian R., Neutralizing monoclonal antibodies to respiratory syncytial virus.
Shimoni,Zvi; Niven,Mark Jonathan; Bulvik,Shlomo, Pharmaceutical compositions and articles of manufacture useful in reversal of a clinical epiosode of an incurable disease and methods of use thereof.
Kniskern Peter J. ; Miller William J. ; Hagopian Arpi ; Ip Charlotte C. ; Hennessey ; Jr. John P. ; Kubek Dennis J. ; Burke Pamela D., Process for making capsular polysaccharides from Streptococcus pneumoniae.
Kotitschke Ronald (Dreieich DEX) Stephan Wolfgang (Dreieich DEX) Mller Wolfgang (Oberursel DEX) Piechaczek Detlef (Mnster DEX) Rudnick Dieter (Dreieich DEX), Process for the preparation of a pharmaceutical which contains IgG, IgA and IgM and can be administered intravenously.
Siber George R. (Brookline MA) Leszczynski Jeanne (Jamaica Plains MA), Process of screening plasma samples for effective antibody titers against respiratory viruses.
Choi, Gil H.; Kunsch, Charles A.; Barash, Steven C.; Dillon, Patrick J.; Dougherty, Brian; Fannon, Michael R.; Rosen, Craig A., Streptococcus pneumoniae SP042 polynucleotides.
Fournier Jean-Michel (Paris FRX), Vaccinating glycopeptidic antigenic fraction with a very high level of immunogenicity, isolated from cultures of pathoge.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.