alexa Immunotherapy of 436 Morphine Addicts by Therapeutic Morphine Vaccine in Kerman Province (I.R. Iran) | Open Access Journals
ISSN: 2157-7560
Journal of Vaccines & Vaccination
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Immunotherapy of 436 Morphine Addicts by Therapeutic Morphine Vaccine in Kerman Province (I.R. Iran)

Ali Farhangi, Azim Akbarzadeh*, Mohammd Reza Mehrabi, Mohsen Chiani, Zahra Saffari, Mehri Mortazavi and Soheil Ghassemi

Pilot Biotechnology Department, Pasteur Institute of Iran, No. 358, 12 Farvardin Street, Jomhoori Avenue, Tehran, Iran

*Corresponding Author:
Dr. Azim Akbarzadeh
Head & Full Professor of Pilot Biotechnology Department
Pasteur Institute of Iran, No. 358
12 Farvardin Street, Jomhoori Avenue
Tehran, Iran, 13169- 43551
Tel: + 98- 21- 6646 5406
Fax: + 98- 21- 6646 5132
E-mail: [email protected]

Received date: October 09, 2012; Accepted date: October 15, 2012; Published date: October 18, 2012

Citation: Farhangi A, Akbarzadeh A, Mehrabi MR, Chiani M, Saffari Z, et al. (2012) Immunotherapy of 436 Morphine Addicts by Therapeutic Morphine Vaccine in Kerman Province (I.R. Iran). J Vaccines Vaccin 3:154.doi:10.4172/2157-7560.1000154

Copyright: © 2012 Farhangi A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Abstract

Morphine vaccine is synthesized by conjugation of morphine- 6- hemisuccinate with BSA. In This Study, 436 addicted volunteers were immunized by morphine vaccine. They were first bled and then received three doses of morphine vaccine on 0, 30 and 60 days. Each dose of injected morphine vaccine contained 50 μg Morphine- 6-succinat –BSA, 0.5 mg Aluminum hydroxide (Al3+), 8 mg Sodium chloride, 1.12 mg Dibasic sodium phosphate anhydrous, 1.1 mg Monobasic sodium phosphate monohydrate and 1 ml Water for injection. After 90 days, all subjects were bled and after 1 year of immunization, 10% of them were bled randomly and total protein, gamma globulin and anti-morphine antibody levels were determined. The amounts of total protein, gamma globulin and antimorphine antibody decreased but did not reach the base line even one year after the last dose of injection. Morphine vaccine has been well tolerated systematically and prevents the vaccinated morphine addicts to restart morphine consumption because the antibody destroys the in taken (consumed) morphine.

Keywords

Morphine vaccine; Immunotherapy; Anti- morphine antibody; Humoral immunity; Morphine- 6- hemisuccinate- BSA conjugate

Introduction

According to the report given by [1], there are 235,200,000 narcotic drug abusers all over the world which 15,900,000 are addicted to morphine and 13,400,000 are addicted to heroine who are mostly residing around golden crescent and golden triangle countries [1]. Addiction to narcotic drugs should not be considered a proud; it is a pain for human society. Drug abusers do not like to show their addiction (illness). However, after passing over 6000 years of discovering opium, yet the human being have not been able to find out solutions to help narcotic drug abusers [2]. The research carried out by different groups all over the world, could not tackle this social obstacle and day by day the numbers are increasing. Historically, the use of opium started 4000 years B.C by man i.e., Sumerians for the first time then Egyptians and Persians used opium. According to WHO report, 3.33% of the world population is suffering from addiction to narcotic drugs and this number is going up day by day. The overcome of this obstacle is of prime importance and introduction of therapeutic morphine vaccine that immunizes the susceptible population against morphine [3] will protect such population. In this research, 436 persons whom were addicted to morphine for at least one year were selected. They were injected with morphine vaccine and their reactions were studied. The idea of Immunotherapy goes back to early 80, getting the idea by battling against war gases like nitrogen mustered, thio- mustered through vaccines. This was led to the production of new generation of vaccines i.e. synthetic vaccines against such gases. In 1990, production of antibody against morphine was started in our laboratory. In 1994, a rapid diagnostic kit to detect morphine in urine was introduced [4]. In 1999, the morphine vaccine was produced in our laboratory and many morphine abusers were vaccinated by such vaccine [5]. This vaccine is produced and controlled according to WHO protocols for vaccines production and quality control. This type of immunotherapy will help the morphine abusers to stop morphine after being vaccinated with vaccine. They neither show any desire to restart morphine abusing nor encounter any life threatening disorders. The psychological addiction in those who are consuming morphine can be disabling and may lead to relapse. The therapeutic morphine vaccine provides a unique approach rather than pharmacotherapy employed to treat the morphine addicted individuals [6]. The mechanism of the action of morphine vaccine can be explained as follows: after the immunization of the addicted individual by such vaccine, if he/she consumes morphine, the morphine will encounter and binds to anti-morphine antibodies on entering the bloodstream, preventing uptake of morphine across the blood-brain barrier systems and dulling or even obliterating the euphoric rush [7]. Furthermore, a therapeutic morphine vaccine based on active immunization has the potential to provide long lasting efficacy in order to prevent relapse with less problem and compliances in individuals who desire to give up their addiction to morphine. This type of vaccine therapy is based on humeral immunity. After administration, it brings about long term immunity which in turn prevents the relapse and does not produce any psychological disorders and break syndrome in those who are willing to give up their addiction to morphine.

Materials and Methods

Synthesis of antigenic morphine 6-hemisuccinate-BSA and antibody production against morphine

The synthesis of morphine- 6-hemisuccinate- BSA conjugation and antibody production was reported earlier by [8,9].

Human studies

The population under study immunized by morphine vaccine has been evaluated through considering 160 parameters included in the evaluation form according to WHO and national protocols. 436 morphine addicted volunteers with the average age of 26.6 (13-58 years old) including 430 males and 6 females were immunized with morphine vaccine. The variables were concentration of anti-morphine antibody, total protein and gamma globulin of the blood system [2,9].

Selection of population under study

The evaluation forms for addicted individuals as out patients were prepared according to WHO and national vaccination protocols and were filled out [2,8]. The following information was used for determination and selection of population under study: A) Place of resident, this includes provinces and islands of the I.R. Iran. B) Individual information such as: First name and surname, gender, marital status (bachelor, married, widow, divorced, separated), number of children B-1) Education: Primary, intermediate & secondary schools, Diploma, Bachelor, Master and Doctorate degrees B-2) Addiction to cigarette, opium, heroine, hashish, alcohol B-3) Duration of addiction, doses used, date of giving up B-4) Present status of addiction: nonaddicted, addicted, occasional abuser B-5) Number of first class family addicted members B-6) Type of the addiction of relatives B-6) Type of the addiction of the first class family members C) Physical conditions: pulses, high/low blood pressure (mm/Hg), body temperature before vaccination and body weight C-1) Quality of nutrition: good, medium, bad C-2) Physical activities: high, medium, low D) Being affected by a disease such as: diabetes, epilepsy, psychological disorder, vitamins deficiency, immunological and skin diseases, chronic infectious disease (like AIDS, Brucellosis and so on), organ transplantation, metabolic disorders and any other illness or diseases must be noted. Name of the drug, duration of drug consumption must be exactly mentioned [10,11].

Side effects studies of morphine vaccine

Detrimental effects of the vaccine after each vaccination of individual under study were not reported. After each shot, the subjects were examined for body temperature, detriment in site of injection such as swelling, skin redness in the form of erythma, indurations, edema and allergy and none of these side effects were observed [12,13].

Immunological evaluation

Immunity of the vaccine was evaluated by measuring the total protein, gamma globulin in serum of the vaccinated volunteers by electrophoresis and anti-morphine antibody was evaluated by direct ELISA method. Sampling of the volunteers was performed up to the day 90th and only in 10% of the volunteers continued up to day 360th (Table 2) [11].

Function of component in vaccine Amount Components
antigen 50 mg Morphine- 6-succinat -BSA
adjuvant 0.5 mg Aluminum hydroxide (Al3+)
buffer 8 mg Sodium chloride
buffer 1.12 mg Dibasic sodium phosphate anhydrous
buffer 1.1 mg Monobasic sodium phosphate monohydrate
solvent 1 ml Water for injection Qs

Table 1: Each dose of morphine vaccine contains.

- - 60 30 0 Days of vaccination
360 90 60 30 0 Days of bleeding
8 8.3 7.87 7.393 7.65 Mean value of total protein (g/dl)
1.17 1.242 1.2237 1.222 0.98 Mean value of gamma globulin (g/dl)
0.8775 0.9315 0.92775 0.9165 0.735 Mean value of anti-morphine antibody (g/dl)

Table 2: Changes in mean values of anti morphine anti-body, total protein and gamma globulin in 436 addicted volunteers in 360 days.

This study was conducted at Pilot Biotechnology Department of Pasteur Institute of Iran and is a part of morphine vaccine production project supported by Pasteur Institute of Iran since 1994.

Results

Morphine vaccine has been well tolerated systematically. The signs like local pain, allergy, rigidity of tissues, fever, inflammation and slight edema on the skin were less observed in the volunteers injected with morphine vaccine as compared to the other 10 kinds of vaccines like B.C.G, Polio, M.M.R and etc being injected at the department of vaccination, Pasteur Institute of Iran, Tehran, thereby showing less unfavorable effects. Morphine vaccine causes the production of specific anti-morphine antibodies resulting in raise of total amount of protein, gamma globulin and anti-morphine antibody (Table 2 and Figure 1). Figure1 shows the mean values of the total protein, gamma globulin and anti-morphine antibody in 5 steps bleeding. Decrease in the amounts of antibody, total protein and gamma globulin in 12 months was natural but they did not reach the base line. Responses to the increase in the amounts of anti-morphine antibody, total protein and gamma globulin above the base line were followed up after first vaccination. The first detectable increase in the amount of anti-morphine antibody, total protein and gamma globulin was found after 30 days of vaccination. After second vaccination strong responses of anti-morphine antibody, total protein and gamma globulin were observed and on third vaccination the above elements were increased. The amount and intensity of the anti-morphine antibody response, total protein and gamma globulin were varied from individual to individual. About 90% of subjects who completed the study quit their addiction. The safety of morphine vaccine has been also studied by employing lohmann specific pathogen free eggs [14].

vaccines-vaccination-gamma-globulin

Figure 1: Changes in mean values of anti morphine anti-body, total protein and gamma globulin in 436 addicted volunteers in 360 days.

Discussion

There are no reports on clinical trial study of morphine vaccine in human other than ours, so there were no references on this issue to refer [2,9]. Morphine vaccine gives better result as compared to cigarette and cocaine vaccines [15,16]. By analyzing the data obtained from the forms of the immunized addicted volunteers by Microsoft Office Access (Table 3), we found the number of subjects whom were in challenge with addiction. It is essential to bring into the notice that in this research the sisters and brothers of the addicted people were not considered and if they were considered the horror of the addiction would appear.

Number Case of inspection
436 Number of volunteers
430 Number of male volunteers
6 Number of female volunteers
13 The age of youngest volunteer
58 The age of oldest volunteer
26.613 Average age of the volunteers
157 Number of married volunteers
246 Number of bachelor volunteers
6 Number of divorced volunteers
6 Number of widow volunteers
347 Total number of children
340 Number of children under supervision of married families
7 Number of children of divorced families
44 Number of families without children
52 Number of families with 1 child
35 Number of families with 2 children
38 Number of families with 3 children
8 Number of families with 4 children
6 Number of families with 5 children
5 Number of families with 6 children
3 Number of families with 7 children
1 Number of families with 8 children
1 Number of families with 20 children
1 Age of the youngest child
20 Age of the oldest child
2.496 Average age of the children
11 Number of illiterate volunteers
169 Number of volunteers with elementary education
149 Number of volunteers with secondary education
68 Number of volunteers holding diploma
5 Number of volunteers holding associate degree
2 Number of volunteers holding bachelor's degree and higher
234 Number of volunteers whose first addiction was cigarette
104 Number of volunteers whose first addiction was opium
23 Number of volunteers whose first addiction was heroine
3 Number of volunteers whose first addiction was hashish (cannabis)
6 Number of volunteers whose first addiction was alcohol
3 Number of volunteers whose second addiction was cigarette
162 Number of volunteers whose second addiction was opium
32 Number of volunteers whose second addiction was heroine
11 Number of volunteers whose second addiction was cannabis
4 Number of volunteers whose second addiction was alcohol
3 Number of volunteers whose third addiction was opium
61 Number of volunteers whose third addiction was heroine
25 Number of volunteers whose third addiction was cannabis
6 Number of volunteers whose third addiction was alcohol
1 Number of volunteers whose forth addiction was cigarette
4 Number of volunteers whose forth addiction was heroine
25 Number of volunteers whose forth addiction was cannabis
23 Number of volunteers whose forth addiction was alcohol
3 The shortest period of addiction
57 The longest period of addiction
6.7 Average period of addiction
49 The least pulse number of volunteers
100 The most pulse number of volunteers
77.97 Average of the pulse number of volunteers
60 The least min. blood pressure of volunteers
100 The most min. blood pressure of volunteers
82 Average of the min. blood pressure of volunteers
80 The least max. blood pressure of volunteers
170 The most max. blood pressure of volunteers
116.244 Average of the max. blood pressure of volunteers
20 The least body temperature of volunteers before injection
37 The most body temperature of volunteers before injection
36.88 Average of the body temperature of volunteers before injection
40 The least body weight of volunteers
106 The most body weight of volunteers
65.63 Average of the body weight of volunteers
10 Number of volunteers with bad condition of nutrition
113 Number of volunteers with normal condition of nutrition
238 Number of volunteers with good condition of nutrition
62 Number of volunteers with low physical activity
196 Number of volunteers with normal physical activity
109 Number of volunteers with high physical activity
27 Number of volunteers with past record of disease
18 Number of volunteers who are addicted at present condition
213 Number of volunteers who are healthy at present condition
42 Number of volunteers who are addicted for amusement at present condition
422 Number of volunteers who were present in the firs stage of vaccination
6.4 The least total of electrophoresis 1
11.1 The most total of electrophoresis 1
7.84 Average of the total of electrophoresis 1
0.1 The least amount of gamma globulin before injection
2.8 The most amount of gamma globulin before injection
0.989 Average of amount of gamma globulin before injection
344 Number of volunteers who were present in the second stage of vaccination
6.3 The least total of electrophoresis 2
14.8 The most total of electrophoresis 2
8.3 Average of the total of electrophoresis 2
0.41 The least amount of gamma globulin 30 days after injection
3.2 The most amount of gamma globulin 30 days after injection
1.231 Average of amount of gamma globulin 30 days after injection
202 Number of volunteers who were present in the third stage of vaccination
6.3 The least total of electrophoresis 3
9.5 The most total of electrophoresis 3
7.793 Average of the total of electrophoresis 3
0.55 The least amount of gamma globulin 60 days after injection
2.4 The most amount of gamma globulin 60 days after injection
1.242 Average amount of gamma globulin 60 days after injection
116 Number of volunteers who were present in the forth stage of vaccination
6.8 The least total of electrophoresis 4
8.6 The most total of electrophoresis 4
7.67 Average of the total of electrophoresis 4
0.51 The least amount of gamma globulin 90 days after injection
2.1 The most amount of gamma globulin 90 days after injection
1.152 Average amount of gamma globulin 90 days after injection

Table 3: Considered points in studying the effect of morphine vaccine in addicts.

In 1997, the population of I.R. Iran was considered to be about 67,000,000 and according to the officially announced reports (through mass media), the number of addicted people were about 3,000,000.

Conclusion

In this study, the levels of anti-morphine antibody, total protein and gamma globulin were declined but did not reach the primary level (base line) in one year. To maintain such antibody level, booster dose is recommended after one year. It seems that, the levels of antibody, total protein and gamma globulin started to decline after about four months (two months after the last dose of administration) (Figure 1) and it is acceptable. The results obtained through clinical studies hopefully guarantee the vaccination of the morphine addicted persons. Likewise, high level of morphine antibody, descends the desire of addicts to restart morphine consumption. Morphine vaccine prevents the vaccinated morphine addicts to restart morphine consumption because the antibody destroys the intaken (consumed) morphine. The vaccine also prevents the advancement of addiction and the relapse. When less amount of such narcotic is consumed by a person for the first time, it causes stimulation and desire to reuse of the drug which results in more consumption leading to addiction. This vaccine highly affects the primary effects of low or medium dose of morphine consumption. The numbers of addicted people, who need to be prevented of restarting the consumption of morphine, are high therefore, they seek kind of treatment with positive outcome but so far such results have not been achieved. This type of vaccination could yield suitable solution to the problem.

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