A phase I study with two vaccination schedules and two doses with TACD

• Research type

  Research Study

• Full title

  A Randomised, Open-Label, Healthy Volunteer Study of two Vaccination Schedules and two Doses (400 µg and 720 µg) with the Vaccine, TA-CD

• Sponsor organisation

  Celtic Pharma Development Services Europe Ltd

• Eudract number

  2008-005990-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  TA-CD vaccine has been developed for the treatment of cocaine dependence. The vaccine is designed to elicit and immune response which will prevent cocaine from entering the brain, thus prohibiting the 'good feeling' associated with taking the drug. This is a phase I, randomised, open-label, healthy volunteer, study of two vaccination schedules and two doses of the vaccine, TA-CD. Healthy volunteers (male or female, aged >18 years) will give written informed consent to participate in the study and will be screened for significant medical and psychiatric conditions that might compromise their safety, their performance in the study or the interpretability of their data. There are inclusion and exclusion criteria which the study doctor will base his decision around to determine subject eligibility for the study. Sixty subjects will be enrolled into this study and randomized in a1:1:1:1 ratio to receive one of two doses and two vaccination schedules. Subjects will attend the clinic for screening, day 0 and on weeks 1, 2, 3, 4, 6, 8 and 12. At these visits subjects will be dosed (if scheduled) and undergo a series of assessments. The assessments include; medical history review; side-effects or injection site reaction review; collection of blood sample for safety tests (including aluminium level test), HIV/HepB/HepC tests, pregnancy test (women of child bearing potential at screening only), antibody level assessment; collection of urine sample for safety tests pregnancy test (women of child bearing potential) and drugs of abuse test; eye examination; physical examination including vitals; electrocardiograph. Subjects will be asked to complete a diary card on the day of their injection and for 5 days after and will return the diary card to the clinic at their next visit. The maximum duration of the study is 13 weeks. Subjects will be paid and travel expenses will be reimbursed.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  08/H0505/162

• Date of REC Opinion

  4 Nov 2008

• REC opinion

  Further Information Favourable Opinion