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Polypeptide vaccine and vaccination strategy against mycobacterium

A technology of Mycobacterium tuberculosis and vaccine, which is applied in the direction of antibacterial immunoglobulin, medical preparations containing active ingredients, antibacterial drugs, etc.

Inactive Publication Date: 2011-02-09
U S GOVERNMENT DEPT OF HEALTH & HUMAN SERVICES SECRETARIAT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Although preliminary studies have been conducted in both human and animal systems with live or killed BCG vaccines, protein subunit vaccines, recombinant bacterial vector vaccines, plasma DNA vaccines, or combined immunization approaches, the which produce the strongest immune response and highest level of protection little is known
Furthermore, details regarding the characteristics of the immune response induced by each vaccine type have yet to be fully elucidated

Method used

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  • Polypeptide vaccine and vaccination strategy against mycobacterium
  • Polypeptide vaccine and vaccination strategy against mycobacterium
  • Polypeptide vaccine and vaccination strategy against mycobacterium

Examples

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Embodiment 1

[0073] Generation of BCG, single and multi-component vaccines: BCG (Copenhagen) vaccines are provided as the reference standard for TB preclinical vaccines by the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA) in Bethesda, USA. The lyophilized BCG vaccine was resuspended in vaccine diluent (diluted Sauton's medium, Statens Serum Institute, Copenhagen, Denmark).

[0074] For the production of single or multi-component vaccines, single doses were prepared in DDA (250 μg / dose, Sigma-Aldrich, St.Louis, MO) and MPL (produced from Salmonella minnesota (Salmonella minnesota) Re 595; 25 μg / dose, Sigma- Aldrich, St. Louis, MO) emulsified in 10 μg of each polypeptide. Emulsions were prepared as described in Sable SB et al., Vaccine, 2005;23:4175-4184. Briefly, MPL was first mixed with endotoxin-free sterile water (Burdick & Jackson, Muskegon, MI) containing 0.2% triethylamine (Fisher Scientific, Fair Lawn, NJ). The mixture was heated in a 70 °C ...

Embodiment 2

[0076] Peptide Production: TB Vaccine Test Funded by the National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID) at the Department of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, CO Nine recombinant M. tuberculosis H37Rv proteins (Table 1), whole cell lysates (WCL), and total short-term culture filtrate proteins (STCF) were obtained from the TB Vaccine Testing and Research Material contract.

[0077] Table 1

[0078]

[0079] Alternatively, specific polypeptides are cloned, expressed and isolated. Illustratively, isolation and characterization were performed as described by Sable, S. et al., Infection and Immunity, 2005; 73:3547-3558 and Sable, S. et al., Vaccine, 2005; 23:4175-4184. Briefly, primers for cloning and sequencing were synthesized at the CDC's Biotechnology Core Facility. The following PCR primers for the gene sequences of Rv0164 (mtsp-17 / TB18.5), Rv0831c (cfp-31) and Rv1324 (cfp-...

Embodiment 3

[0083] Inoculation of subjects: For mouse subjects, inject 50 μl above the gluteus superficialis muscle and biceps femoralis muscle in both hind legs by using a 26 gauge injection needle BCG suspension (7×10 5 CFU) to deliver the BCG vaccine by subcutaneous inoculation. A total of 30 μl of BCG vaccine (7×10 5 CFU) were applied to the external nostrils (15 μl per nostril) and the mice were allowed to naturally inhale the suspension into the lungs to administer the BCG vaccine. For all studies, BCG vaccine diluent was used as a control for any route of administration. Vaccination of human subjects is performed similarly. BCG dosing in human subjects administered by intranasal or subcutaneous injection was between 1-8 x 10 5 between CFUs.

[0084] The multicomponent vaccine was delivered intranasally to mice three times at 2-week intervals as described above, except that 90 μg per dose of the recombinant M. tuberculosis protein mixture (10 μg of each polypeptide) was used. ...

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Abstract

A vaccine is provided wherein a polypeptide or combination of peptides from M. tuberculosis is administered to a subject to elicit an immune response. The polypeptide vaccine is administered as part of a prime-boost strategy with BCG vaccine to increase the immunoprotection in a subject such that prevention or elimination of disease is achieved. Finally, a pharmaceutical package is provided that encompasses a polypeptide vaccine for M. tuberculosis that when administered to a subject elicits immunoprotection.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application Serial No. 61 / 020,573, filed January 11, 2008, which is hereby incorporated by reference. [0003] government interest [0004] The invention described herein may be made, used and licensed by or for the United States Government. technical field [0005] The present invention relates generally to the field of recombinant vaccines and vaccination methods. More particularly, the invention relates to the administration of recombinant Mycobacterium tuberculosis proteins for use in a prime-boost immunization strategy. Background technique [0006] Every year, 8 to 10 million people worldwide suffer from tuberculosis. The global incidence of tuberculosis is increasing at a rate of 1% per year, mainly due to the rapid increase in the prevalence of the disease in Africa. In other regions, successful control efforts have begun to stabilize disease inciden...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/16C07K16/12
CPCA61K39/04A61P31/06
Inventor 苏拉吉·塞布尔邦尼·B·普利卡亚蒂斯托马斯·M·欣尼克拉玛·罗亚·阿玛拉马尼·舍吕武
Owner U S GOVERNMENT DEPT OF HEALTH & HUMAN SERVICES SECRETARIAT
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