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Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection
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- Publication Date:February 13, 2024
- معلومة اضافية
- Patent Number: 11897,943
- Appl. No: 17/397915
- Application Filed: August 09, 2021
- نبذة مختصرة : 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.
- Inventors: ADMA Biologics, Inc. (Ramsey, NJ, US)
- Assignees: ADMA BIOMANUFACTURING, LLC (Boca Raton, FL, US)
- Claim: 1. A method of treating an upper respiratory tract infection, the method comprising: administering to a subject a therapeutically effective amount of an immunotherapeutic composition comprising immune globulin prepared from pooled plasma samples from healthy adult human plasma donors vaccinated with a primary and a secondary anti-pneumococcal vaccine, wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group consisting of S. pneumonia serotypes 1, 2, 3, 4, 5, 6A, 6B, 7A, 7B, 7C, 7D, 7E, 7F, 8, 9A-9V, 12, 14, 18C, 19A-19F, 23A-23F, and 25, wherein the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes are each at least 3-fold higher than the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes present in a control sample, wherein the control sample is immune globulin prepared from plasma pooled from 500 or more random human plasma donors that have not been vaccinated with an anti-pneumococcal vaccine.
- Claim: 2. The method of claim 1 , wherein the method comprises therapeutically treating the upper respiratory tract infection.
- Claim: 3. The method of claim 1 , wherein the method comprises prophylactically treating the upper respiratory tract infection.
- Claim: 4. The method of claim 1 , wherein the method further comprises administrating one or more biologically active agents.
- Claim: 5. The method of claim 4 , wherein the one or more biologically active agents is selected from the group consisting of antibodies, anti-toxin material, anti-inflammatory agents, anti-cancer agents, antimicrobial agents, therapeutic agents, antihistamines, cytokines, chemokines, and vitamins.
- Claim: 6. The method of claim 1 , wherein the immunotherapeutic composition further comprises a mono-specific, bi-specific or multi-specific antibody with specificity toward a bacterial or fungal toxin.
- Claim: 7. The method of claim 6 , wherein the bacterial or fungal toxin is selected from the group consisting of Botulinum neurotoxin, Tetanus toxin, E. coli toxin, Clostridium difficile toxin, Vibrio RTX toxin, Staphylococcal toxins, Cyanobacteria toxin, and mycotoxins.
- Claim: 8. The method of claim 1 , wherein the immunotherapeutic composition comprises neutralizing antibodies specific for one or more of Corynebacterium diphtheria , measles virus, polio virus, and Haemophilus influenza.
- Claim: 9. The method of claim 1 , wherein the subject is selected from the group consisting of an end stage renal disease (ESRD) patient, a patient on immunosuppressive therapy, an AIDS patient, a diabetic patient, a neonate, a transplant patient, a patient with malfunctioning immune system, an elderly person, a patient with autoimmune disease, a burn patient, a cancer patient, and a patient in an acute care setting.
- Claim: 10. The method of claim 1 , wherein the subject has a primary immunodeficiency disease (PIDD).
- Claim: 11. The method of claim 1 , wherein the immunogenic composition treats or prevents the upper respiratory tract infection in the subject.
- Claim: 12. The method of claim 1 , wherein the upper respiratory tract infection is caused by S. pneumonia.
- Claim: 13. The method of claim 1 , wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group of S. pneumonia serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
- Claim: 14. The method of claim 13 , wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group of S. pneumonia serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, wherein the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes are each at least 5-fold higher than the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes present in the control sample.
- Claim: 15. The method of claim 13 , wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group of S. pneumonia serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, wherein the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes are each at least 10-fold higher than the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes present in the control sample.
- Patent References Cited: 4021540 May 1977 Pollack et al.
4174388 November 1979 McAleer et al.
4185084 January 1980 Mochida et al.
4256631 March 1981 Yokoo et al.
4305870 December 1981 Liu et al.
4308026 December 1981 Mochida et al.
4318902 March 1982 Stephan
4346073 August 1982 Aronson et al.
4356170 October 1982 Jennings et al.
4376110 March 1983 David et al.
4402939 September 1983 Fournier
4482483 November 1984 Curry et al.
4486530 December 1984 David et al.
4587121 May 1986 Collins et al.
4617379 October 1986 Dobkin et al.
4659563 April 1987 Dobkin
4665159 May 1987 Dobkin
4717564 January 1988 Dobkin
4717766 January 1988 Dobkin
4800078 January 1989 Prince et al.
4801450 January 1989 Collins et al.
4863730 September 1989 Karpas
5075425 December 1991 Kotitschke et al.
5138034 August 1992 Uemura et al.
5360897 November 1994 Anderson et al.
5412077 May 1995 Siber et al.
5455032 October 1995 Kenny et al.
5505945 April 1996 Gristina
5530102 June 1996 Gristina et al.
5582827 December 1996 Siber et al.
5614382 March 1997 Metcalf
5679768 October 1997 Briles et al.
5728387 March 1998 Briles et al.
5804193 September 1998 Briles et al.
5817312 October 1998 Gristina et al.
5847112 December 1998 Kniskern et al.
5891438 April 1999 Silverman
5945098 August 1999 Sarno et al.
5965141 October 1999 Briles et al.
5985264 November 1999 Metzger et al.
6224880 May 2001 Chan et al.
6262029 July 2001 Press et al.
6372216 April 2002 Piazza
6685942 February 2004 Burton et al.
6692739 February 2004 Patti et al.
6815172 November 2004 Martinez et al.
6818216 November 2004 Young et al.
6893639 May 2005 Levy et al.
6929930 August 2005 Choi et al.
6962700 November 2005 Pollack
6984492 January 2006 Betez et al.
7045131 May 2006 Patti et al.
7070786 July 2006 Scallon
7229619 June 2007 Young et al.
7323172 January 2008 Young et al.
7364742 April 2008 Scallon
7488486 February 2009 Shimoni et al.
7553489 June 2009 Young et al.
7597891 October 2009 Simon
7879331 February 2011 Zurlo et al.
7879332 February 2011 Zurlo et al.
8221759 July 2012 Pilkington et al.
8252546 August 2012 Briles et al.
8293242 December 2012 Zurlo et al.
8354249 January 2013 Nur et al.
8546548 October 2013 Teschner et al.
8772462 July 2014 Teschner et al.
8796430 August 2014 Bruckschwaiger et al.
8889838 November 2014 Teschner et al.
8921520 December 2014 Teschner et al.
8940877 January 2015 Bruckschwaiger et al.
8993734 March 2015 Bruckschwaiger et al.
9107906 August 2015 Grossman
9139642 September 2015 Williamson et al.
9175068 November 2015 Teschner et al.
9365635 June 2016 Nur et al.
9468675 June 2016 Teschner et al.
9403900 August 2016 Williamson et al.
9447173 September 2016 Gurnett-Bander et al.
9708391 July 2017 Teschner et al.
9714283 July 2017 Grossman et al.
9815886 November 2017 Grossman et al.
9969793 May 2018 Grossman et al.
20010051708 December 2001 Laursen
20020010428 January 2002 Vedrine et al.
20020038111 March 2002 Alchas
20020051788 May 2002 Pozsgay
20020094338 July 2002 Jonsdottir
20020107265 August 2002 Chen
20020159997 October 2002 Patti et al.
20030099672 May 2003 Schultz
20030105307 June 2003 Sampson et al.
20030118591 June 2003 Levy
20030133929 July 2003 Cham
20030147922 August 2003 Capiau et al.
20030162260 August 2003 Minion et al.
20040047882 March 2004 Broeker
20040052804 March 2004 Arumugham et al.
20040156857 August 2004 Adalsteinsson et al.
20040228879 November 2004 Deschamps et al.
20050031646 February 2005 Capiau et al.
20050053605 March 2005 Betz et al.
20050070876 March 2005 Castellano
20050158329 July 2005 Ghosh
20050208608 September 2005 Raven
20050260694 November 2005 Piasio
20050287146 December 2005 Patti et al.
20060002961 January 2006 Capiau et al.
20060093626 May 2006 Capiau et al.
20060110407 May 2006 Stopera et al.
20060121059 June 2006 Garcon et al.
20060198848 September 2006 Betz et al.
20060222651 October 2006 Patti et al.
20070009542 January 2007 Levin et al.
20070037170 February 2007 Nur et al.
20070154492 July 2007 Michon et al.
20070161088 July 2007 Arumugham et al.
20070231344 October 2007 Leadbetter et al.
20070244305 October 2007 Parkkinen
20070249550 October 2007 Sitkovsky
20080026002 January 2008 Danzig
20080066739 March 2008 LeMahieu
20080286838 November 2008 Yuan et al.
20090004218 January 2009 Hacohen et al.
20090010964 January 2009 Grobler et al.
20090028846 January 2009 Miescher
20090047353 February 2009 O'Hagan
20090136547 May 2009 Telford et al.
20090191217 July 2009 de Wildt et al.
20090232798 September 2009 Betz et al.
20090269359 October 2009 Scuderi et al.
20100040601 February 2010 Cantin et al.
20100074922 March 2010 Biemans
20100143394 June 2010 Kasmi et al.
20100266625 October 2010 Tai et al.
20100290996 November 2010 Nickerson et al.
20110020386 January 2011 Gierahn et al.
20110059085 March 2011 Kim
20120027771 February 2012 Cantor
20120121578 May 2012 Block
20130108619 May 2013 Melamed
20130195876 August 2013 Smith
20140322263 October 2014 Siber
20150133644 May 2015 Bruckschwaiger
20160024186 January 2016 Wang
20160114037 April 2016 Grossman et al.
20160145321 May 2016 Wadia et al.
20160145322 May 2016 Wadia et al.
20160194383 July 2016 Williamson et al.
20160244512 August 2016 Teschner et al.
20170029488 February 2017 Gurnett-Bander et al.
20170121394 May 2017 Vora et al.
692678 March 1996
2002368447 June 2004
2472818 December 2005
2749367 July 2010
1241937 January 2000
1899609 January 2007
101024079 August 2007
101130071 February 2008
101374548 February 2009
101590224 December 2009
101785857 July 2010
102068690 May 2011
5210947 October 2002
0035429 September 1981
0161188 November 1985
0168322 January 1986
0186576 July 1986
0208375 January 1987
0378881 July 1990
0383184 August 1990
0399001 November 1990
0427347 May 1991
0449856 October 1991
0471177 February 1992
0477508 April 1992
0497524 August 1992
0497525 August 1992
0571538 December 1993
0622081 November 1994
0625910 November 1994
0720485 July 1996
0778781 June 1997
0831901 April 1998
0848011 June 1998
0877624 November 1998
0894008 February 1999
0969873 January 2000
0971945 January 2000
0977588 February 2000
0983087 March 2000
1015027 July 2000
1019437 July 2000
1035137 September 2000
1076662 February 2001
1109576 June 2001
1124576 August 2001
1137789 October 2001
1162998 December 2001
1171159 January 2002
1296715 April 2003
1317279 June 2003
1501542 February 2005
1558280 August 2005
1590373 November 2005
1638601 March 2006
1651261 May 2006
1704167 September 2006
1776962 April 2007
1791860 June 2007
1838345 October 2007
1868645 December 2007
1880735 January 2008
1928418 June 2008
1962899 September 2008
2167531 March 2010
2180901 May 2010
2277535 January 2011
2010260849 November 2010
2011057713 March 2011
20110068831 June 2011
2239453 November 2004
WO 91/01146 February 1991
WO 91/12819 September 1991
WO 93/15758 August 1993
WO 94/04195 March 1994
WO 95/13294 May 1995
WO 96/21465 July 1996
WO 96/40225 December 1996
WO 97/20940 June 1997
WO 98/18931 May 1998
WO 98/33521 August 1998
WO 98/39450 September 1998
WO 99/03884 January 1999
WO 99/15205 April 1999
WO 99/40936 August 1999
WO 99/47168 September 1999
WO 00/12132 March 2000
WO 01/72337 March 2000
WO 00/56360 September 2000
WO 00/61761 October 2000
WO 00/62801 October 2000
WO 00/062802 October 2000
WO 00/63385 October 2000
WO 01/96368 December 2001
WO 02/40518 May 2002
WO 02/056909 July 2002
WO 03/040170 May 2003
WO 03/051392 June 2003
WO 2004/064864 August 2004
WO 2004/097000 November 2004
WO 2005/058940 June 2005
WO 2005/065382 July 2005
WO 2005/070458 August 2005
WO 2005/073252 August 2005
WO 2005/108580 November 2005
WO 2005/120563 December 2005
WO 2006/027685 March 2006
WO 2006/065137 June 2006
WO 2006/084467 August 2006
WO 2007/017859 February 2007
WO 2007/068907 June 2007
WO 2007/071711 June 2007
WO 2007/109129 September 2007
WO 2007/113598 October 2007
WO 2007/116028 October 2007
WO 2007/116322 October 2007
WO 2007/116409 October 2007
WO 2008/021076 February 2008
WO 2008/081014 July 2008
WO 2008/081022 July 2008
WO 2008/102173 August 2008
WO 2008/119358 October 2008
WO 2008/157590 December 2008
WO 2009/000826 December 2008
WO 2009/016515 February 2009
WO 2009/076158 June 2009
WO 2009/106085 September 2009
WO 2009/143413 November 2009
WO 2010/015701 February 2010
WO 2010/064243 June 2010
WO 2010/094720 August 2010
WO 2010/109324 September 2010
WO 2010/109325 September 2010
WO 2010/141312 December 2010
WO 2010/150242 December 2010
WO 2011/031893 March 2011
WO 2011/041691 April 2011
WO 2011/067758 June 2011
WO 2011/080595 July 2011
WO 2011/103588 August 2011
WO 2011/110241 September 2011
WO 2011/110531 September 2011
WO 2013/071267 May 2013
WO 2013/115962 August 2013
WO 2016/069693 May 2016 - Other References: Romero-Steiner et al., (Clin Vaccine Immunol. Feb. 2006; 13(2): 165-169). (Year: 2006). cited by examiner
European Patent Office, Extended European Search Report for European Application No. 21212658.5 dated Jun. 13, 2022. cited by applicant
Rospatent, Official Action (Inquiry) of the Substantive Examination for Russian Application No. 2018109264/04(014245), dated Dec. 17, 2021. cited by applicant
Japan Patent Office, Notification of Reasons for Refusal for Japanese Application No. Tokugan 2020-500018, dated Oct. 14, 2021. cited by applicant
Adler, S. P., & Nigro, G. (2009). Findings and conclusions from CMV hyperimmune globulin treatment trials. Journal of Clinical Virology, 46, S54-S57. cited by applicant
Alejandria, M. M., Lansang, M. A. D., Dans, L. F., & Mantaring III, J. B. (2013). Intravenous immunoglobulin for treating sepsis, severe sepsis and septic shock. The Cochrane Library., full document. cited by applicant
Aschermann, S., Lux, A., Baerenwaldt, A., Biburger, M., & Nimmerjahn, F. (2010). The other side of immunoglobulin G: suppressor of inflammation. Clinical & Experimental Immunology, 160(2), 161-167. cited by applicant
Balmer et al., Anti-pneumococcal antibody titre measurement: what useful information does it yield? J Clin Pathol., 2006;60(4):345-350. cited by applicant
Balmer et al., Measurement and interpretation of pneumococcal IgG levels for clinical management, Clin Exp Immunol. Sep. 2003;133(3):364-9. cited by applicant
Ben-Nathan, D., Gershoni-Yahalom, O., Samina, I., Khinich, Y., Nur, I., Laub, O., . . . & Orr, N. (2009). Using high titer West Nile intravenous immunoglobulin from selected Israeli donors for treatment of West Nile virus infection. BMC infectious diseases, 9(1), 18. cited by applicant
Bhakdi, S. U. C. H. A. R. I. T., Mannhardt, U., Muhly, M., Hugo, F., Ronneberger, H., & Hungerer, K. D. (1989). Human hyperimmune globulin protects against the cytotoxic action of staphylococcal alpha-toxin in vitro and in vivo. Infection and immunity, 57(10), 3214-3220. cited by applicant
Boukhvalova et al., Treatment with 1-15 C97K novel RSV Ig RI-992 controls viral A61K replication and reduces pulmonary damage in Unocompromised Sigmodon hispidus, Bone Marrow Transplantation, vol. 1, No. 1, Sep. 14, 2015 (2015-99-14), pp. 119-126. cited by applicant
Brandtzaeg, P. (2009). Mucosal immunity: induction, dissemination, and effector functions. Scandinavian journal of immunology, 70(6), 505-515. cited by applicant
Buchacher, Purification of intravenous immunoglobulin G from human plasma—aspects of yield and virus safety, Biotechnol. J., 1, pp. 148-163, 2006. cited by applicant
Buehring et al., Chronic sinusitis refractory to standard management in patients with humoral immunodeficiencies, Clin Exp Immunol 1997, 109:468-472. cited by applicant
Busse, P. J., Razvi, S., & Cunningham-Rundles, C. (2002). Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency. Journal of Allergy and Clinical Immunology, 109(6), 1001-1004. cited by applicant
Casadevall, A., & Scharff, M. D. (1994). Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrobial agents and chemotherapy, 38(8), 1695-1702. cited by applicant
Casadevall, A., Dadachova, E., & Pirofski, L. A. (2004). Passive antibody therapy for infectious diseases. Nature Reviews Microbiology, 2(9), 695-703. cited by applicant
Casal, J., Aguilar, L., Jado, I., Yuste, J., Giménez, M. J., Prieto, J., & Fenoll, A. (2002). Effects of specific antibodies against Streptococcus pneumoniae on pharmacodynamic parameters of β-lactams in a mouse sepsis model. Antimicrobial agents and chemotherapy, 46(5), 1340-1344. cited by applicant
Clark, L. A., & Easmon, C. S. (1986). Opsonic activity of intravenous immunoglobulin preparations against Staphylococcus epidermidis. Journal of clinical pathology, 39(8), 856-860. cited by applicant
Cohn et al., Preparation and properties of serum and plasma proteins; a system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids, J Am Chem Soc, 62, 459-475 (1946). cited by applicant
Cortez, K., Murphy, B. R., Almeida, K. N., Beeler, J., Levandowski, R. A., Gill, V. J., . . . & Bennett, J. E. (2002). Immune-globulin prophylaxis of respiratory syncytial virus infection in patients undergoing stem-cell transplantation. The Journal of infectious diseases, 186(6), 834-838. cited by applicant
Corthesy, Recombinant secretory IgA for immune intervention against mucosal pathogens, Biochem. Soc. Trans. 1997; 25:471-475. cited by applicant
Crottet et al., Expression, purification and biochemical characterization of recombinant murine secretory component: a novel tool in mucosal immunology, Biochem. J. 1999; 341:299-306. cited by applicant
De Hennezel, L., Ramisse, F., Binder, P., Marchal, G., & Alonso, J. M. (2001). Effective combination therapy for invasive pneumococcal pneumonia with ampicillin and intravenous immunoglobulins in a mouse model. Antimicrobial agents and chemotherapy, 45(1), 316-318. cited by applicant
Devincenzo et al., Respiratory syncytial virus immune globulin treatment of lower respiratory tract infection in pediatric patients undergoing bone marrow transplantation—a compassionate use experience, Bone Marrow Transplantation, vol. 25, No. 2, Jan. 1, 2000 (2090-91-91), pp. 161-165. cited by applicant
Dorner et al., At what stage should virus inactivation be carried out?, Dev Biol Stand 1993 vol 81, pp. 137-143. cited by applicant
European Search Report of co-pending European patent application No. 15190963.7 dated May 3, 2016, 10 pages. cited by applicant
European Search Report of co-pending European patent application No. 18161907 dated Jun. 19, 2018, 11 pages. cited by applicant
Falsey et al, A Summary of the Study of a Polyclonal Human IVIG with A Standardized High-Levels of RSV Neutralizing Antibodies, IDSA International Conference, Aug. 21, 2013. cited by applicant
Falsey et al., Acute respiratory tract infection in daycare centers for older persons, J Am Geriatr Soc. 1995;43:30-36. cited by applicant
Falsey et al., Human metapneumovirus infections in young and elderly adults, J Infect Dis. 2003;187:785-790. cited by applicant
Falsey et al., The “common cold” in frail older persons: impact of rhinovirus and coronavirus in a senior daycare center, J Am Geriatr Soc. 1997;45:706-711. cited by applicant
Falsey et al., Viral respiratory infections in the institutionalized elderly: clinical and epidemiologic findings, J Am Geriatr Soc. 1992;40:115-119. cited by applicant
Favre et al., Intravenous immunoglobulin replacement prevents severe and lower respiratory tract infections, but not upper respiratory tract and non-respiratory infections in common variable immune deficiency, Allergy 2005 60:385-390. cited by applicant
Fischer, L., Gerstel, P. F., Poncet, A., Siegrist, C. A., Laffitte, E., Gabay, C., . . . & Ribi, C. (2015). Pneumococcal polysaccharide vaccination in adults undergoing immunosuppressive treatment for inflammatory diseases—a longitudinal study. Arthritis research & therapy, 17(1), 151. cited by applicant
Fried, A. J., & Bonilla, F. A. (2009). Pathogenesis, diagnosis, and management of primary antibody deficiencies and infections. Clinical microbiology reviews, 22(3), 396-414. cited by applicant
Gelfand, Clinical uses of intravenous immunoglobulin continue to expand, Medscape Allergy & Immunology, 2004, pp. 1-4. cited by applicant
Goldblatt et al., The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin Infect Dis. Nov. 1, 2009;49(9):1318-25. cited by applicant
Hamill et al., IgG Antibody Reactive with Five Serotypes of Streptococcus pneumoniae in Commercial Intravenous Immunoglobulin Preparations, The Journal of Infectious Diseases, vol. 166, No. 1 (Jul. 1992), pp. 38-42. cited by applicant
Hemming, V. G., Prince, G. A., Groothuis, J. R., & Siber, G. R. (1995). Hyperimmune globulins in prevention and treatment of respiratory syncytial virus infections. Clinical microbiology reviews, 8(1), 22-33. cited by applicant
Hopkins, Clinical Efficacy of Intramuscular Vaccinia Immune Globulin: A Literature Review, Clinical Infectious Diseases, 39, pp. 819-826, 2004. cited by applicant
Hügler, P., Siebrecht, P., Hoffmann, K., Stücker, M., Windeler, J., Altmeyer, P., & Laubenthal, H. (2002). Prevention of postherpetic neuralgia with varicella-zoster hyperimmune globulin. European journal of pain, 6(6), 435-445. cited by applicant
International Search Report and Written Opinion for PCT/US2018/022701, dated Jul. 10, 2018, 10 pages. cited by applicant
Ishizaka, A., Sakiyama, Y., Otsu, M., Ozutsumi, K., & Matsumoto, S. (1994). Successful intravenous immunoglobulin therapy for recurrent pneumococcal otitis media in young children. European journal of pediatrics, 153(3), 174-178. cited by applicant
Iwata et al., Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study. Hum Vaccin Immunother. 2015;11(4): 826-37. cited by applicant
Jones et al, Controlled trial of Pseudomonas immunoglobulin and vaccine in burn patients, Lancet. Dec. 13, 1980;2(8207):1263-5. cited by applicant
Keller and Stiehm, Passive Immunity in Prevention and Treatment of Infectious Diseases, Clin. Microbiol. Rev. 2000, 13(4): pp. 602-614. cited by applicant
Kim et al., Opsonophagocytic Antibodies to Serotype Ia, Ib, and III Group B Streptococcus among Korean Infants and in Intravenous Immunoglobulin Products. J Korean Med Sci. May 2017;32(5):737-743. cited by applicant
Kudoyarova-Zubavichene, N. M., Sergeyev, N. N., Chepurnov, A. A., & Netesov, S. V. (1999). Preparation and use of hyperimmune serum for prophylaxis and therapy of Ebola virus infections. Journal of Infectious Diseases, 179(Supplement 1), S218-S223. cited by applicant
Lake, J. R. (2008). Do we really need long-term hepatitis B hyperimmune globulin? What are the alternatives ?. Liver Transplantation, 14(S2), S23-S26. cited by applicant
Lal, G., Balmer, P., Stanford, E., Martin, S., Warrington, R., & Borrow, R. (2005). Development and validation of a nonaplex assay for the simultaneous quantitation of antibodies to nine Streptococcus pneumoniae serotypes. Journal of immunological methods, 296(1), 135-147. cited by applicant
Laupland, K. B., Kirkpatrick, A. W., & Delaney, A. (2007). Polyclonal intravenous immunoglobulin for the treatment of severe sepsis and septic shock in critically ill adults: a systematic review and meta-analysis. Critical care medicine, 35(12), 2686-2692. cited by applicant
Lejtenyi, D., & Mazer, B. (2008). Consistency of protective antibody levels across lots of intravenous immunoglobulin preparations. Journal of Allergy and Clinical Immunology, 121(1), 254-255. cited by applicant
Lullau et al., Antigen binding properties of purified immunoglobulin A and reconstituted secretory immunoglobulin A antibodies, J. Biol. Chem. 1996; 271:16300-16309. cited by applicant
Martin, Remington's Pharmaceutical Sciences, 15th Ed., Mack Publ. Co., Easton, Pa. (1975). cited by applicant
Martinez et al., A Flow Cytometric Opsonophagocytic Assay for Measurement of Functional Antibodies Elicted after Vaccination with the 23-Valent Pneumococcal Polysaccharide Vaccine. Clin Diagnostic Lab Immunol., 1999;6(4):581-6. cited by applicant
Meijvis, S. C. A., Grutters, J. C., Thijsen, S. F., Rijkers, G. T., Biesma, D. H., & Endeman, H. (2011). therapy in pneumonia: what is beyond antibiotics ?. Arterial and venous thrombosis: more in common than previously thought, 21. cited by applicant
Miernyk et al., Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Alaska Native Adults 55-70 Years of Age. Clinical Infections Diseases Jul. 2009;49(2)241-248. cited by applicant
Mikolajczyk, M. G., Concepcion, N. F., Wang, T., Frazier, D., Golding, B., Frasch, C. E., & Scott, D. E. (2004). Characterization of antibodies to capsular polysaccharide antigens of Haemophilus influenzae type b and Streptococcus pneumoniae in human immune globulin intravenous preparations. Clinical and diagnostic laboratory immunology, 11(6), 1158-1164. cited by applicant
Mikolajczyk et al., Characterization of antibodies to capsular polysaccharide antigens of Haemophilus influenzae type b and Streptococcus pneumoniae in human immune globulin intravenous preparations. Clinical and diagnostic laboratory immunology, (2004). 11(6), 1158-1164. cited by applicant
Mofenson et al.,Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. The National Institute of Child Health and Human Developments Intravenous Immunoglobulin Study Group, The New England Journal of Medicine, Jul. 11, 1991, vol. 325, No. 2, pp. 73-80. cited by applicant
Murphy, B. R., Prince, G. A., Walsh, E. E., Kim, H. W., Parrott, R. H., Hemming, V. G., . . . & Chanock, R. M. (1986). Dissociation between serum neutralizing and glycoprotein antibody responses of infants and children who received inactivated respiratory syncytial virus vaccine. Journal of clinical microbiology, 24(2), 197-202. cited by applicant
Nation, N. S., Pierce, N. F., Adler, S. J., Chinnock, R. F., & Wehrle, P. F. (1963). Tetanus—the use of human hyperimmune globulin in treatment. California medicine, 98(6), 305. cited by applicant
Navarrete-Navarro, S., Aguilar-Setién, A., Avila-Figueroa, C., Hernández-Sierra, F., & Santos-Preciado, J. I. (1999). Improved serological response to human diploid cell rabies vaccine when given simultaneously with antirabies hyperimmune globulin. Archives of medical research, 30(4), 332-337. cited by applicant
Nimmerjahn, F., & Ravetch, J. V. (2008). Anti-inflammatory actions of intravenous immunoglobulin. Annu. Rev. Immunol., 26, 513-533. cited by applicant
Oncely, J. L. et al., The Separation of the Antibodies, Isoagglutinins, Prothrombin, Plasminogen and B1-Lipoprotein into subfractions of human plasma, J. Am Chem Soc. 71:541-550 (1949). cited by applicant
Orange et al, Therapeutic Immunoglobulin Selected for High Antibody Titer to RSV also Contains High Antibody Titers to Other Respiratory Viruses, Frontiers in Immunology, vol. 6, Aug. 28, 2015 (2915-98-28), pp. 1-7. cited by applicant
Orange, J. S., Hossny, E. M., Weiler, C. R., Ballow, M., Berger, M., Bonilla, F. A., . . . & Nelson Jr, R. P. (2006). Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol, 117(4 Suppl), S525-S553. cited by applicant
Ottolini, M. G., Porter, D. D., Hemming, V. G., Zimmerman, M. N., Schwab, N. M., & Prince, G. A. (1999). Effectiveness of RSVIG prophylaxis and therapy of respiratory syncytial virus in an immunosuppressed animal model. Bone marrow transplantation, 24(1), 41-45. cited by applicant
Paris, K., & Sorensen, R. U. (2007). Assessment and clinical interpretation of polysaccharide antibody responses. Annals of Allergy, Asthma & Immunology, 99(5), 462-464. cited by applicant
Ramakrishna et al., Passively administered pooled human immunoglobulins exert IL-10 dependent anti-inflammatory effects that protect against fatal HSV encephalitis, Plos Pathogens. 2011. 7:6:e1002071. cited by applicant
Ramisse et al., Passive and active immunotherapy for experimental pneumococcal pneumonia by polyvalent human immunoglobulin or F(ab')2 fragments administered intranasally. J Infect Dis. May 1996;173(5):1123-8. cited by applicant
Roe, E. A., Jones, R. J., & Dyster, R. E. (1986). Passive immunization of mice against Klebsiella aerogenes. British journal of experimental pathology, 67(1), 25-32. cited by applicant
Romero-Steiner et al., Multilaboratory Evaluation of a Viability Assay for Measurement of Opsonophagocytic Antibodies Specific to the Capsular Polysaccharides of Streptococcus pneumoniae. Clin Diagn Lab Immunol. Nov. 2003;10(6):1019-24. cited by applicant
Romero-Steiner et al., Standardization of an opsonophagocytic assay for the measurement of functional antibody activity against Streptococcus pneumoniae using differentiated HL-60 cells, 1997 Clin Diagn Lab Immunol. Jul;4(4):415-22. cited by applicant
Rudrawar, Novel sialic acid derivatives lock open the 150-loop of an influenza A virus group-1 sialidase, Nature Communications, 1(113), 2010. cited by applicant
Salehzadeh et al., Evaluation of Immunoglobulin Levels and Infection Rate in Patients with Common Variable Immunodeficiency After Immunoglobulin Replacement Therapy, J Microbiol Immunol Infect 2010, 43(1):11-17. cited by applicant
Schwab, IVIg-mediated amelioration of ITP in mice is dependent on sialic acid and SIGNR1, Eur. J. Immunol., 42, pp. 826-830, 2012. cited by applicant
Scott et al., Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. Aug. 14, 2007;25(33):6164-6. cited by applicant
Shurin et al., Bacterial polysaccharide immune globulin for prophylaxis of acute otitis media in high-risk children, The Journal of Pediatrics, Nov. 1993, pp. 801-810. cited by applicant
Siber George R et al, Comparison of antibody concentrations and protective activity of respiratory syncytial virus A immune globulin and conventional immune globulin, Journal of Infectious Diseases. Jid, University of Chicago Press, Chicago, IL, vol. 169, No. 6, Jan. 1, 1994 (1994-81-81), pp. 1368-1373. cited by applicant
Siber, G. R., Ambrosino, D. M., McIver, J., Ervin, T. J., Schiffman, G., Sallan, S., & Grady, G. F. (1984). Preparation of human hyperimmune globulin to Haemophilus influenzae b, Streptococcus pneumoniae, and Neisseria meningitidis. Infection and immunity, 45(1), 248-254. cited by applicant
Siber, G. R., Leszczynski, J., Pena-Cruz, V., Ferren-Gardner, C., Anderson, R., Hemming, V. G., . . . & Anderson, L. J. (1992). Protective activity of a human respiratory syncytial virus immune globulin prepared from donors screened by microneutralization assay. Journal of Infectious Diseases, 165(3), 456-463. cited by applicant
Simao-Gurge et al., Prospective evaluation of Streptococcus pneumoniaeserum antibodies in patients with primaryimmunodeficiency on regular intravenousimmunoglobulin treatment, Allergo Immnopathol 2017, 45: 55-62. cited by applicant
Simoes et al., Respiratory syncytial virus-enriched globulin for the prevention of acute otitis media in high-risk children, Journal of Pediatrics v 129, No. 2, pp. 214-219, 1996. cited by applicant
Spiekermann, G. M., Finn, P. W., Ward, E. S., Dumont, J., Dickinson, B. L., Blumberg, R. S., & Lencer, W. I. (2002). Receptor-mediated immunoglobulin G transport across mucosal barriers in adult life. Journal of Experimental Medicine, 196(3), 303-310. cited by applicant
Stiehm, Standard and special human immune serum globulins as therapeutic agents, Pediatrics, vol. 63, No. 1, 301-319 (1979). cited by applicant
Stott, E. J. et al., Respiratory syncytial virus. Brief review, Archives of Virology, 84:1-52 (1985). cited by applicant
Tanaka, High quality human immunoglobulin G purified from Cohn fractions by liquid chromatography, Brazilian Journal of Medical and Biological Research, 33: 27-30, 2000. cited by applicant
Teschner et al., A new liquid, intravenous immunoglobulin product (IGIV 10%) highly purified by a state-of-the-art process, Vox Sang. Jan. 2007;92(1):42-55. cited by applicant
Tijssen, P., Laboratory Techniques in Biochemistry and Molecular Biology: Practice and Theory of Enzyme Immunoassays, (Burdon & van Knippenberg eds., 3rd ed.,1985) Elsevier, New York. cited by applicant
Tuerlinckx, D., Florkin, B., Ferster, A., De Schutter, I., Chantrain, C., Haerynck, F., . . . & Laub, R. (2014). Pneumococcal antibody levels in children with PID receiving immunoglobulin. Pediatrics, 133(1), e154-e162. cited by applicant
US FDA standards for immune globulin preparation (37 CFR §§640.100; 640.101; 640.102; 640.103; and 640.104, Apr. 1, 2013). cited by applicant
Westerman, L. E., McClure, H. M., Jiang, B., Almond, J. W., & Glass, R. I. (2005). Serum IgG mediates mucosal immunity against rotavirus infection. Proceedings of the National Academy of Sciences of the United States of America, 102(20), 7268-7273. cited by applicant
World Health Organization. (2007). Pneumococcal conjugate vaccine for childhood immunization, WHO position paper. Wkly Epidemiol Rec, 82(12), 93-104. cited by applicant
World Intellectual Property Organization, Patent Landscape Report on Vaccines for Selected Infectious Diseases, 2012. cited by applicant
Wu et al., Immunoprophylaxis of RSV Infection: Advancing from RSV-IGIV to Palivizumab and Motavizumab, Curr Topics Microbiol Immunol. vol. 317, pp. 103-123, 2008. cited by applicant
Yoshida, M., Claypool, S. M., Wagner, J. S., Mizoguchi, E., Mizoguchi, A., Roopenian, D. C., . . . & Blumberg, R. S. (2004). Human neonatal Fc receptor mediates transport of IgG into luminal secretions for delivery of antigens to mucosal dendritic cells. Immunity, 20(6), 769-783. cited by applicant
Zaia et al., A practical method for preparation of varicella-zoster immune globulin, The Journal of Infectious Diseases, vol. 137, No. 5, 601-604 (1978). cited by applicant - Primary Examiner: Hines, Jana A
- Attorney, Agent or Firm: Casimir Jones SC
Sisk, Tyler - الرقم المعرف: edspgr.11897943
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