Investigation of Safety and Immunogenicity of Human Morphine Vaccine in Morphine Addicts

Abstract

Background and Objectives: Morphine vaccine is obtained by synthesizing morphine-6-succinate and conjugating it with bovine serum albumin. Each dose of morphine vaccine contains 0.5 mg of aluminum hydroxide, 8 mg of sodium chloride, 1.12 mg of disodium hydrogen phosphate, 1.1 mg of sodium dihy drogen phosphate and 50 micrograms of morphine-6-succinate-bovine serum albumin and one milliliter of water (Water For Injection). By injecting 3 doses of morphine vaccine at a time interval of (1-30-60) days, humoral immunity is established in addicts willing to quit morphine addiction. Immunization of morphine vaccine causes addiction withdrawal without withdrawal syndrome in addicts interested in quitting addiction. The aim of this study was to investigate the effect of vaccination of morphine addicts who were interested in quitting morphine addiction with morphine vaccine.

Materials and Methods: This study is a clinical trial that was conducted according to the protocol of the Ethics Committee of the Pasteur Institute of Iran, the National Committee and the World Health Organization on 102 morphine addicts who volunteered to quit morphine addiction (male) with an average age of 25 years. Variables include vaccine dose and antimorphine antibody concentration. The volunteers were divided into three groups of 30 people and 4 placebo people. To the adjuvant placebo group and to the first to third groups, respectively, 12.5, 100 and 600 micrograms of morphine vaccine in a volume of one milliliter (Water For Injection) on the first (1st, 30th and 60th) days of blood sampling, then morphine vaccine was injected into the deltoid muscle. All of them returned for examination on the 90th day. From all three groups, blood sampling and evaluation were also done on the 5th, 7th, 9th, 11th and 12th months. The antibody was used.

Findings: The amount of antibody was directly correlated with the dose of vaccine and the number of injections. Antimorphine antibodies with doses of 100 μg/ml and 600 μg/ml were detected after the first injection, and a dose of 12.5 μg/ml was detected after the second injection dose. The antibody titer reached its highest value within 3 months and did not decrease to its baseline value even after one year.

Conclusion: In the addicts who volunteered to quit morphine addiction, the morphine vaccine was well tolerated and did not have the negative and adverse effects related to the vaccines. Morphine vaccine induced humoral immunity in all subjects on day 90.