Join
today

Boliven PRO is more than just patent search

  • Build and save lists using the powerful Lists feature
  • Analyze and download your search results
  • Share patent search results with your clients

Patents »

US8076131: Settings for recombinant adenoviral-based vaccines

Share

Filing Information

Inventor(s) Ronald Vogels · Maria Grazia Pau · Lennart Holterman · Stefan Kostense · Menzo Jans Emco Havenga · Mieke Caroline Sprangers ·
Assignee(s) Crucell Holland B.V. ·
Attorney/Agent(s) TraskBritt, P.C. ·
Primary Examiner Bo Peng ·
Application Number US12583628
Filing date 08/24/2009
Issue date 12/13/2011
Prior Publication Data
Predicted expiration date 02/17/2024
Patent term adjustment 117
U.S. Classifications 435/320.1  · 424/932  · 435/456  · 435/455  ·
International Classifications C12N1500  · C12N1509  · C12N1563  ·
Kind CodeB2
Related U.S. Application DataCROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional of U.S. patent application Ser. No. 11/105,725, filed Apr. 14, 2005, now U.S. Pat. No. 7,598,078, which application is a continuation of International Patent Appln. No. PCT/EP03/050748, filed on Oct. 23, 2003, designating the United States of America, and published, in English, as PCT International Publication No. WO 2004/037294 A2 on May 6, 2004, which claims priority under 35 U.S.C. §119 to International Patent Application No. PCT NL02/00671, filed Oct. 23, 2002, the contents of the entirety of each of which are incorporated by this reference.
Foreign Priority WO20PCTNL0200671 - 10/23/2002 ·
13 Claims, 37 Drawings


Abstract

The present invention provides new uses of recombinant adenoviral vectors in vaccination regimens, such as prime/boost set-ups and subsequent vaccinations and applications for gene therapy. Moreover, the invention provides new assays to determine the best regimen for applying the most suitable recombinant viral vector in a vaccination or gene therapy setting.

Independent Claims | See all claims (13)

  1. 1. A method of delivering a polynucleotide of interest to a subject utilizing an adenoviral delivery vehicle, the method comprising: administering to the subject a recombinant adenovirus vector of Ad35 serotype having a polynucleotide encoding a malaria antigen; and administering to the subject, subsequent to administering the recombinant adenovirus vector of the Ad35 serotype, a recombinant adenovirus vector of Ad26 serotype having a polynucleotide encoding essentially the same malaria antigen.
  2. 2. A method of delivering a polynucleotide encoding a malaria antigen to a subject, the method comprising: administering a recombinant adenovirus vector of Ad26 serotype to a subject previously administered a recombinant adenovirus vector of Ad35 serotype, wherein the recombinant adenovirus vector of Ad35 serotype and the adenovirus vector of Ad26 serotype each comprise a polynucleotide encoding essentially the same malaria antigen.
  3. 3. A kit of parts comprising a priming composition and a boosting composition, the kit of parts comprising: a priming composition comprising: a first recombinant adenovirus vector of Ad35 serotype comprising a polynucleotide encoding a malaria antigen, and a pharmaceutically acceptable carrier; and a boosting composition comprising a second recombinant adenovirus vector of Ad26 serotype comprising a polynucleotide encoding a malaria antigen and a pharmaceutically acceptable carrier.
  4. 5. A method of delivering a polynucleotide encoding a malaria antigen to a subject, the method comprising: administering a recombinant adenovirus vector of Ad26 serotype to a subject previously administered a recombinant adenovirus vector of Ad35 serotype, wherein the recombinant adenoviruses each comprise a polynucleotide encoding essentially the same malaria antigen.
  5. 6. A method of delivering a polynucleotide encoding a malaria antigen to a human or animal, the method comprising: screening a human or animal for the presence of neutralizing antibodies against an adenovirus of Ad35 serotype; and administering a recombinant adenovirus vector of a Ad35 serotype encoding a malaria antigen, and subsequently with a recombinant adenovirus of Ad26 serotype encoding essentially the same malaria antigen.
  6. 7. A method of delivering polynucleotides encoding a malaria antigen to a subject, the method comprising: screening a subject for the presence of neutralizing antibodies against an adenovirus of Ad35 serotype; administering to the subject a recombinant adenovirus vector of Ad35 serotype comprising a first polynucleotide encoding the malaria antigen; and subsequent thereto, administering to the subject a recombinant adenovirus of Ad26 serotype comprising a second polynucleotide encoding the malaria antigen, so as to deliver the first and second polynucleotides encoding the malaria antigen to the subject.
  7. 8. A method of delivering a polynucleotide of interest to a subject utilizing an adenoviral delivery vehicle, the method comprising: administering to the subject a recombinant adenovirus vector of Ad26 serotype having a polynucleotide encoding a malaria antigen; and administering to the subject, subsequent to administering the recombinant adenovirus vector of Ad26 serotype, a recombinant adenovirus vector of Ad35 serotype having a polynucleotide encoding essentially the same malaria antigen.
  8. 9. A method of delivering a polynucleotide encoding a malaria antigen to a subject, the method comprising: administering a recombinant adenovirus vector of Ad35 serotype to a subject previously administered a recombinant adenovirus vector of Ad26 serotype, wherein the recombinant adenovirus vector of Ad26 serotype and the adenovirus vector of Ad35 serotype each comprise a polynucleotide encoding essentially the same malaria antigen.
  9. 10. A kit of parts comprising two immunological compositions, the kit of parts comprising: a first immunological composition comprising: a first recombinant adenovirus vector of Ad35 serotype comprising a polynucleotide encoding a malaria antigen, and a pharmaceutically acceptable carrier; and a second immunological composition comprising: a second recombinant adenovirus vector of Ad26 serotype comprising a polynucleotide encoding a malaria antigen, and a pharmaceutically acceptable carrier, wherein the malaria antigen in the first and second recombinant adenovirus are essentially the same.
  10. 13. A method of delivering a polynucleotide encoding a malaria antigen to a subject, the method comprising: administering a recombinant adenovirus vector of Ad35 serotype to a subject previously administered a recombinant adenovirus vector of Ad26 serotype, wherein the recombinant adenoviruses each comprise a polynucleotide encoding essentially the same malaria antigen.

References Cited

U.S. Patent Documents

Document NumberAssigneesInventorsIssue/Pub Date
US5922315 Genetic Therapy, Inc. Roy Jul 1999
US5994128 IntroGene B.V. Fallaux et al. Nov 1999
US6492169 Crucell Holland, B.V. Vogels et al. Dec 2002
US6670188 Crucell Holland B.V. Vogels et al. Dec 2003
US6733993 Merck & Co., Inc. Emini et al. May 2004
US6913922 Crucell Holland B.V. Bout et al. Jul 2005
US7300657* Crucell Holland B.V. Pau et al. Nov 2007
US7387894* Crucell Holland B.V. Pau et al. Jun 2008
US7867764* Pau et al. Jan 2011
US20030044421 Emini Mar 2003

Foreign Patent Documents

Document NumberAssigneesInventorsIssue/Pub Date
EP99201545.3May 1999
EP0978566Crucell Holland B.V.Feb 2000
WO199626281Aug 1996
WO199832842Jul 1998
WO199850053Nov 1998
WO199964582INTROGENE B.V.Dec 1999
WO200003029INTROGENE B.V.Jan 2000
WO200052186INTROGENE B.V.Sep 2000
WO200060106MERCK & CO., INC.Oct 2000
WO200070071INTROGENE B.V.Nov 2000
WO200102607MERCK & CO., INC.Jan 2001
WO200121201ISIS INNOVATION LIMITEDMar 2001
WO200222080MERCK & CO., INC.Mar 2002
WO200224730CRUCELL HOLLAND B.V.Mar 2002
WO2002053759Jul 2002
WO2004028478MEDIMMUNE VACCINES, INC.Apr 2004
* cited by examiner

Other Publications

Rodrigues EG et al. “Single Immunizing Dose of Recombinant Adenovirus Efficiently Induces CD8+ T Cell-Mediated Protective Immunity Against Malarial” J. Immunology 158:1268-1274, 1997.*
Bostic et al., Quantitative Analysis of Neutralizing Immune Response to Human Parvovirus B19 Using a Novel Reverse Transcriptase-Polymerase Chain Reaction-Based Assay, Journal of Infectious Diseases, 1999, pp. 619-626, vol. 179, Chicago, IL, US.
European Search Report, EP 03 78 0172, dated Dec. 6, 2007.
Hsu et al., “Immunogenicity of Recombinant Adenovirus-Respiratory Syncytial Virus Vaccines with Adenvirus Types 4, 5, and 7 Vectors in Dogs and a chimpanzee,” Journal of Infectious Diseases, Oct. 1, 1992, pp. 769-775, vol. 166, No. 4.
Kass-Eisler et al., “Circumventing the immune response to adenovirus-mediated gene therapy,” Gene Therapy, Feb. 1, 1996, pp. 154-162, vol. 2, No. 3.
Klein et al., Accurate estimation of transduction efficiency necessitates a multiplex real-time PCR, Gene Therapy, 2000, pp. 458-463, vol. 7.
Lubeck et al., “Immunogenicity and efficacy testing in chimpanzees of an oral hepatitis B vaccine based on live recombinant adenovirus,” Proc. Natl. Acad. Sci. USA, 1989, pp. 6763-6767, vol. 86, No. 17.
Mack et al., “Circumvention of Anti-Adenovirus Neutralizing Immunity by Administration of an Adenoviral Vector of an Alternate Serotype,” Human Gene Therapy, 1997, pp. 99-109, vol. 8, No. 1.
Mastrangeli et al., “‘Sero-Switch’ Adenovirus-Mediated in Vivo Gene Transfer: Circumvention of Anti-Adenovirus Humoral Immune Defenses Against Repeat Adenovirus Vector Administration by Changing the Adenovirus Serotype,” Human Gene Therapy, 1996. pp. 79-87, vol. 7, No. 1.
Moffatt et al., “Circumvention of Vector-Specific Neutralizing Antibody Response by Alternating Use of Human and Non-Human Adenoviruses: Implications in Gene Therapy,” Virology, Jun. 30, 2000, pp. 159-167, vol. 272, No. 1.
Natuk et al., “Adenovirus Vectored Vaccines,” Developments in Biological Standardization, 1994, pp. 71-77, vol. 82.
Natuk et al., “Adenovirus—human deficiency virus (HIV) envelope recombinant vaccines elicit high-titered HIV-neutralizing antibodies in the dog model,” Proc. Natl. Acad. Sci. USA, Aug. 1992, pp. 7777-7781, vol. 89, No. 16.
Natuk et al., “Immunogenicity of Recombinant Human Adenovirus—Human Immunodeficiency Virus Vaccines in Chimpanzees,” AIDS Research and Human Retroviruses, 1993, pp. 395-404, vol. 9, No. 5.
Nishimura et al., Determination of a Statistically Valid Neutralization Titer in Plasma That Confers Protection against Simian-Human Immunodeficiency Virus Challenge following Passive Transfer of High-Titered Neutralizing Antibodies, Journal of Virology, Mar. 2002, pp. 2123-2130, vol. 76, No. 5.
Parks et al., “Use of a helper-dependent adenoviral vectors of alternative serotype permits repeat vector administration,” Gene Therapy, Sep. 1999, pp. 1565-1573, vol. 6, No. 1.
PCT International Preliminary Examination Report, PCT/EP03/50748, dated Feb. 14, 2005.
PCT International Search Report, PCT/EP03/50748, dated Sep. 27, 2004.
Rodrigues et al., Single immunizing dose of recombinant adenovirus efficiently induces CD8+ T cell-mediated protective immunity against malaria, J. Immunol., Feb. 1, 1997, pp. 1268-1274, vol. 158, No. 3.
Roy et al., “Circumvention of Immunity to the Adenovirus Major Coat Protein Hexon,” Journal of Virology, Aug. 1998, pp. 6875-6879, vol. 72, No. 8.
Schroter et al., Quantitative Detection of Hepatitis C Virus RNA by Light Cycler PCR and Comparison with Two Different PCR Assays, Journal of Clinical Microbiology, Feb. 2001, pp. 765-768, vol. 39, No. 2.
Spenlehauer et al., A Luciferase-Reporter Gene-Expressing T-Cell Line Facilitates Neutralization and Drug-Sensitivity Assays That Use Either R5 or X4 Strains of Human Immunodeficiency Virus Type 1, Virology, 2001, pp. 292-300, vol. 280.
Sprangers et al., Quantifying Adenovirus-Neutralizing Antibodies by Luciferase Transgene Detection: Addressing Preexisting Immunity to Vaccine and Gene Therapy Vectors, Journal of Clinical Microbiology, Nov. 2003, pp. 5046-5052, vol. 41, No. 11.
Tetteh et al., Progress and challenges towards the development of malaria vaccines, Biogruds, 2007, pp. 357-373, vol. 21, No. 6.
Vogels et al., Replication-Deficient Human Adenovirus Type 35 Vectors for Gene Transfer and Vaccination: Efficient Human Cell Infection and Bypass of Preexisting Adenovirus Immunity, Journal of Virology, Aug. 2003, pp. 8263-8271, vol. 77, No. 15.
Stallwood et al., Neutralisation of adenovirus infectivity by ascetic fluid from ovarian cancer patients, Gene Ther., Apr. 2000, pp. 637-643, vol. 7, No. 8.
U.S. Appl. No. 11/018,669, filed Dec. 20, 2004, Vogels et al., Gene Delivery Vectors Provided With a Tissue Tropism for Smooth Muscle Cells, and/or Endothelial Cells.
U.S. Appl. No. 11/105,725, filed Apr. 14, 2005, Havenga et al., New Settings for Recombinant Adenoviral-Based Vaccines.
U.S. Appl. No. 11/140,418, filed May 27, 2005, Vogels et al., Serotype of Adenovirus and Uses Thereof.
U.S. Appl. No. 11/207,626, filed Aug. 18, 2005, Havenga et al., Chimaeric Adenoviruses.
U.S. Appl. No. 11/384,850, filed Mar. 20, 2006, Havenga et al., Packaging Cells for Recombinant Adenovirus.
U.S. Appl. No. 11/586,316, filed Oct. 25, 2006, Bout et al., Serotypes of Adenovirus and Uses Thereof.
U.S. Appl. No. 11/665,276, filed Apr. 11, 2007, Havenga et al., Improved Adenoviral Vectors and Uses Thereof.
U.S. Appl. No. 11/665,393, filed Apr. 13, 2007, Pau et al., Malaria Prime/Boost Vaccines.
U.S. Appl. No. 11/667,975, filed May 16, 2007, Havenga et al., Multivalent Vaccines Comprising Recombinant Viral Vectors.
U.S. Appl. No. 11/786,409, filed Apr. 11, 2007, Vogels et al., Complementing Cell Lines.
U.S. Appl. No. 11/800,871, filed May 7, 2007, Vogels et al., Means and Methods for the Production fo Adenovirus Vectors.
U.S. Appl. No. 11/809,697, filed Jun. 1, 2007, Hateboer et al., Recombinant Protein Production in a Human Cell.
U.S. Appl. No. 11/879,422, filed Jul. 16, 2007, Marzio et al., Production of Viruses, Viral Isolates and Vaccines.
U.S. Appl. No. 11/899,572, filed Sep. 5, 2007, Vogels et al., Stable Adenoviral Vectors and Methods for Propagation Thereof.
U.S. Appl. No. 11/975,396, filed Oct. 18, 2007, Pau et al., Recombinant Viral-Based Malaria Vaccines.
U.S. Appl. No. 11/978,043, filed Oct. 25, 2007, Vogels et al., New Settings for Recombinant Adenoviral-Based Vaccines.
U.S. Appl. No. 11/980,222, filed Oct. 29, 2007, Bout et al., Serotypes of Adenovirus and Uses Thereof.
U.S. Appl. No. 12/225,259, filed Sep. 16, 2008, Barouch et al., Recombinant Adenoviruses Based on Serotype 26 and 48, and Use Thereof.
U.S. Appl. No. 12/225,673, filed Sep. 26, 2008, Havenga et al., Compositions Comprising a Recombinant Adenovirus and an Adjuvant.
U.S. Appl. No. 12/317,508, filed Dec. 23, 2008, Pau et al., Malaria Prime/Boost Vaccines.
U.S. Appl. No. 12/380,095, filed Feb. 24, 2009, Pau et al., Production of Vaccines.
U.S. Appl. No. 12/454,095, filed May 12, 2009, Pau et al., Production of Vaccines.
U.S. Appl. No. 12/455,086, filed May 28, 2009, Vogels et al., Gene Delivery Vectors Provided With a Tissue Tropism for Smooth Muscle Cells, and/or Endothelial Cells.
U.S. Appl. No. 11/786,409, filed Apr. 11, 2007, Vogels et al., Complementing Cell Lines.
Sprangers et al., Quantifying Adenovirus-Neutralizing Antibodies by Luciferase Transgene Detection: Addressing Preexisting Immunity to Vaccine and Gene Therapy Vectors, Journal of Clinical Microbiology, Nov. 2003, pp. 5046-5052, vol. 41, No. 11.
Electronic Receipt and Express Abandonment filed for U.S. Appl. No. 11/978,043, dated Apr. 5, 2011.
* cited by examiner

Referenced By

Document NumberAssigneeInventorsIssue/Pub Date
US8546123 --

Patent Family

The current document is not in a family.