SAFETY AND IMMUNOGENECITY OF HUMAN THERAPEUTIC MORPHINE VACCINE IN MORPHINE ADDICTS

Background and Morphine vaccine is a product of morphine-6- succinate synthesis and its conjugation with albumin serum. Each dose contains 0.5 mg Aluminum hydroxide, 8 mg sodium chloride, 1.12 mg di- sodium hydrogen phosphate, 1.1 mg sodium di- hydrogen phosphate and 50 mg morphine-6- succinate albumin serum. Humoral safety is achieved in morphine addicts following three successive doses within 0-30- 60-day intervals. Its immunogenicity brings about withdrawal without the risk of abstinence syndrome. This study was conducted to examine the effect morphine vaccine on morphine addicts. Methods and Materials: Based on the Ethics protocol of Pasteur Institute of Iran, this clinical trial was conducted on 102 male volunteer addicts (mean age 25 years). Variables included vaccine dosage and concentration on of antibodies. Volunteers were divided into groups of 30 (experimental) and 4 (placebo). Adjuant was injected to placebo group addicts; the three experimental groups were given 5, 12, 100 and 600 mg within 0- 30-60 days interval through injection to deltoid; all subjects referred for follow-up on the 90th day. Blood samples and antibody evaluation was obtained from all three groups in months 5, 7, 9, 11 and 12. A positive correlation was observed between antibody production and vaccine dosage as well as frequency of injection. Anti-morphine antibody was detected after the first injection of 100mg/ml, 600mg/ml and second injection of 12.5mg/ml doses. Antibody levels reached the peak by three months and did not decline to the baseline after one year the vaccine was well tolerated and lacked the reverse and unfavorable effects, characteristic of vaccines and drugs. On day 90, humoral immunity was created in all patients.