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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
NIH Director’s Pioneer Award (NDPA) (DP1)
Project #
5DP1DA033502-03
Application #
8540992
Study Section
Special Emphasis Panel (ZDA1-SXC-E (18))
Program Officer
Chiang, Nora
Project Start
2011-09-30
Project End
2016-08-31
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
3
Fiscal Year
2013
Total Cost
$751,200
Indirect Cost
$271,200
Name
Baylor College of Medicine
Department
Psychiatry
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
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Kosten, Therese A; Shen, Xiaoyun Y; Kinsey, Berma M et al. (2014) Attenuation of cocaine-induced locomotor activity in male and female mice by active immunization. Am J Addict 23:604-7
Orson, Frank M; Wang, Rongfu; Brimijoin, Stephen et al. (2014) The future potential for cocaine vaccines. Expert Opin Biol Ther 14:1271-83
Kosten, Thomas; Domingo, Coreen; Orson, Frank et al. (2014) Vaccines against stimulants: cocaine and MA. Br J Clin Pharmacol 77:368-74
Shen, Xiaoyun Y; Kosten, Therese A; Lopez, Angel Y et al. (2013) A vaccine against methamphetamine attenuates its behavioral effects in mice. Drug Alcohol Depend 129:41-8