YEARS

2011-2017

AUTHORS

Thomas Richard Kosten

TITLE

Human methamphetamine vaccine: Translational Avante Garde Award

ABSTRACT

Item Number 7. Project Summary/Abstract: Research Plan PROJECT SUMMARY/ABSTRACT Four factors make this methamphetamine (MA) vaccine ready for clinical translation: 1. Our candidate vaccine has optimal adjuvant and antibody responses; 2. Our partnering Chinese manufacturer has Chinese FDA support for the vaccine IND and matching clinical study funds; 3. The PI has 15 years experience developing medications in China and a successful cocaine vaccine. We can accelerate MA vaccine development well beyond the 15 years needed for cocaine in the USA, because the manufacturer has Chinese government financial and FDA support and commercial incentives from the lack of approved treatments for MA. Our R01(DA023898) has identified an optimal carrier protein - Keyhole Limpet Hemocyanin (KLH), which is already approved for human use, and an approved Chinese squalene lipid adjuvant that is better than standard alum to optimize the anti-MA antibody response to vaccination. The optimal KLH-adjuvant vaccine combination will be determined within two years by correlating the quality and quantity of the induced antibodies with inhibition of MA locomotion and self-administration behavior in rats and primates. We then rapidly moved into cGMP synthesis, animal toxicology, CMC, IND filing and phase 1 and 2a clinical trials in years four/five. 4. Concurrently with this Chinese human vaccine, we plan to renew R01-DA023898 to develop a similar lipid adjuvant vaccine in collaboration with the Sabin Vaccine Institute, which is moving to Baylor in July 2011 and has a squalene adjuvant (Easai, E6020) with FDA approval. These two linked programs will have major practical impacts on MA's profound morbidity in the USA and China through collaborative vaccine development between American and Chinese investigators and manufacturers to produce a first and potentially a second generation vaccine quickly into clinical development in the USA and Asia.

FUNDED PUBLICATIONS

  • Dose-dependent changes in the locomotor responses to methamphetamine in BALB/c mice: low doses induce hypolocomotion.
  • Vaccines against stimulants: cocaine and MA.
  • A vaccine against methamphetamine attenuates its behavioral effects in mice.
  • Attenuation of cocaine-induced locomotor activity in male and female mice by active immunization.
  • Prospects, promise and problems on the road to effective vaccines and related therapies for substance abuse.
  • Probing cocaine-antibody interactions in buffer and human serum.
  • Spontaneous development of IgM anti-cocaine antibodies in habitual cocaine users: effect on IgG antibody responses to a cocaine cholera toxin B conjugate vaccine.
  • The future potential for cocaine vaccines.
  • Can you vaccinate against substance abuse?
  • Hapten optimization for cocaine vaccine with improved cocaine recognition.
  • How to use: Click on a object to move its position. Double click to open its homepage. Right click to preview its contents.

    Download the RDF metadata as:   json-ld nt turtle xml License info


    27 TRIPLES      17 PREDICATES      28 URIs      9 LITERALS

    Subject Predicate Object
    1 grants:5591cf108c23206e448641d1c43705b5 sg:abstract Item Number 7. Project Summary/Abstract: Research Plan PROJECT SUMMARY/ABSTRACT Four factors make this methamphetamine (MA) vaccine ready for clinical translation: 1. Our candidate vaccine has optimal adjuvant and antibody responses; 2. Our partnering Chinese manufacturer has Chinese FDA support for the vaccine IND and matching clinical study funds; 3. The PI has 15 years experience developing medications in China and a successful cocaine vaccine. We can accelerate MA vaccine development well beyond the 15 years needed for cocaine in the USA, because the manufacturer has Chinese government financial and FDA support and commercial incentives from the lack of approved treatments for MA. Our R01(DA023898) has identified an optimal carrier protein - Keyhole Limpet Hemocyanin (KLH), which is already approved for human use, and an approved Chinese squalene lipid adjuvant that is better than standard alum to optimize the anti-MA antibody response to vaccination. The optimal KLH-adjuvant vaccine combination will be determined within two years by correlating the quality and quantity of the induced antibodies with inhibition of MA locomotion and self-administration behavior in rats and primates. We then rapidly moved into cGMP synthesis, animal toxicology, CMC, IND filing and phase 1 and 2a clinical trials in years four/five. 4. Concurrently with this Chinese human vaccine, we plan to renew R01-DA023898 to develop a similar lipid adjuvant vaccine in collaboration with the Sabin Vaccine Institute, which is moving to Baylor in July 2011 and has a squalene adjuvant (Easai, E6020) with FDA approval. These two linked programs will have major practical impacts on MA's profound morbidity in the USA and China through collaborative vaccine development between American and Chinese investigators and manufacturers to produce a first and potentially a second generation vaccine quickly into clinical development in the USA and Asia.
    2 sg:endYear 2017
    3 sg:fundingAmount 4033446.0
    4 sg:fundingCurrency USD
    5 sg:hasContribution contributions:6893ca0b1f352d027d4f9993d55138df
    6 sg:hasFieldOfResearchCode anzsrc-for:11
    7 anzsrc-for:1107
    8 sg:hasFundedPublication articles:060d071d77472d08884ba01830e282dc
    9 articles:106894183c683b3256424381fffa3b3c
    10 articles:262207229496b98a5ae45d4f2cb53f78
    11 articles:2b65e7622977b69a53ce9edcf3bb2d7e
    12 articles:6de3932e5ec6256aa5829e3a65d07baf
    13 articles:92e14c18f8205aeccbf3c1b76659e4fe
    14 articles:b4671c4e2b7b8dabe6303938dcff3793
    15 articles:cf7d8f5ca14e7ee2256e88d3e4963d00
    16 articles:e1f6e1ca2aa2037fb1bb7634f69f96ab
    17 articles:fa9587e6c759f80ecdf8eb53a7a7f81a
    18 sg:hasFundingOrganization grid-institutes:grid.420090.f
    19 sg:hasRecipientOrganization grid-institutes:grid.39382.33
    20 sg:language English
    21 sg:license http://scigraph.springernature.com/explorer/license/
    22 sg:scigraphId 5591cf108c23206e448641d1c43705b5
    23 sg:startYear 2011
    24 sg:title Human methamphetamine vaccine: Translational Avante Garde Award
    25 sg:webpage http://projectreporter.nih.gov/project_info_description.cfm?aid=8913925
    26 rdf:type sg:Grant
    27 rdfs:label Grant: Human methamphetamine vaccine: Translational Avante Garde Award
    HOW TO GET THIS DATA PROGRAMMATICALLY:

    JSON-LD is a popular JSON format for linked data.

    curl -H 'Accept: application/ld+json' 'http://scigraph.springernature.com/things/grants/5591cf108c23206e448641d1c43705b5'

    N-Triples is a line-based linked data format ideal for batch operations .

    curl -H 'Accept: application/n-triples' 'http://scigraph.springernature.com/things/grants/5591cf108c23206e448641d1c43705b5'

    Turtle is a human-readable linked data format.

    curl -H 'Accept: text/turtle' 'http://scigraph.springernature.com/things/grants/5591cf108c23206e448641d1c43705b5'

    RDF/XML is a standard XML format for linked data.

    curl -H 'Accept: application/rdf+xml' 'http://scigraph.springernature.com/things/grants/5591cf108c23206e448641d1c43705b5'






    Preview window. Press ESC to close (or click here)


    ...