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Effects of Oral Levamisole as an Adjuvant to Hepatitis B Vaccine in HIV/ AIDS Patients: A Randomized Controlled Trial.

Sayad B, Alavian SM, Najafi F, Soltani B, Shirvani M, Janbakhsh A, Mansouri F, Afsharian M, Vaziri S, Alikhani A, Bashiri H - Hepat Mon (2012)

Bottom Line: Since the immune response of HIV patients to hepatitis B vaccination is less robust than that found in healthy individuals, this study aimed to evaluate the effect of a levamisole adjuvant on increasing the immune response.The immune response and the mean titer of antibody were not associated with; age, sex, body mass index, history of smoking and/or intravenous drug use in either of the groups.However, regarding CD4+ cells more than 200 cell/mm3, mean antibody production significantly increased in both groups.

View Article: PubMed Central - PubMed

Affiliation: Liver Disease and Hepatitis Research Center, Kermanshah University of Medical Sciences, Kermanshah, IR Iran.

ABSTRACT

Background: Human immunodeficiency virus (HIV) infected patients are also frequently exposed to the hepatitis B virus (HBV), due to the common routes of transmission, therefore, prevention of hepatitis B results in decreased complications of the disease.

Objectives: Since the immune response of HIV patients to hepatitis B vaccination is less robust than that found in healthy individuals, this study aimed to evaluate the effect of a levamisole adjuvant on increasing the immune response.

Patients and methods: In this study, 89 HIV infected patients, without a history of HBV infection or vaccination, were randomly allocated into experimental (44 patients) and control (45 patients) groups. HBV vaccination was performed using the Hepavax-Gene TF vaccine, 40 μg three times at intervals of; zero, one, and three months. Levamisole 50 mg twice a day or a placebo, was administered to the experimental and control groups, respectively, for a period of six days before to six days after the vaccination. Immune response was evaluated by measuring hepatitis B surface antibodies (HBsAb) concurrently with the second and third vaccine administration, and at one and three months at the conclusion of the vaccination program.

Results: The immune response following the threevaccinations was higher in those who were receiving levamisole compared with the controls (90% vs. 65.38%) (P = 0.05). Furthermore, the immune response and the mean antibody titer following the repeated vaccination in the experimental group showed a higher increase than in the control group. The immune response and the mean titer of antibody were not associated with; age, sex, body mass index, history of smoking and/or intravenous drug use in either of the groups. However, regarding CD4+ cells more than 200 cell/mm3, mean antibody production significantly increased in both groups.

Conclusions: Using levamisole with the hepatitis B vaccination can increase the immune response and antibody titer mean in HIV infected patients. Since these patients have a more complete response with CD4+ cells more than 200 cell/mm3, vaccination and effective adjuvants seem to be most beneficial when CD4+ cells are greater than 200 cell/mm3, in HIV infected patients.

No MeSH data available.


Related in: MedlinePlus

Trend of Antibody Production in the Experimental and Control Groups
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fig396: Trend of Antibody Production in the Experimental and Control Groups

Mentions: As shown, the level of immune response in the experimental group was significantly higher than in the controls, and this increased with repeated vaccination. Furthermore, the mean titer of HBsAb one month after the third vaccination was 56.05 IU/mL in the experimental group and 40.12 IU/mL in the control group, and three months after the third vaccination it had increased to 53.76 IU/mL and 45.15 IU/mL in the experimental and control groups, respectively (Figure 2). According to Figure 2, the mean antibody production in the experimental group was higher than the control group. The level of immune response one month after the first vaccination was 20.69% in the experimental group, and 34.38% in the controls (OR = 0.50, 95%CI: 0.16-1.6), at the same time, the mean antibody titer was 9.07 and 17.35 in the experimental and the control groups, respectively. The level of immune response two months after the second vaccination was 55% in the experimental group and 48.28% in the controls (OR = 1.31, 95% CI: 0.42-4.11) while the antibody titer was reported to be 38.85 and 36.01 in the experimental and control groups, respectively (Figure 1 and 2). None of the variables of age or body mass index had a significant association with antibody production (P > 0.05). Moreover, the effect of the study variables including; sex, age, body mass index, history of smoking, history of opium use, history of intravenous drug use, history of receiving antiretroviral drugs, and mean count of CD4+ cells, on the trend of immune response and mean antibody titer were evaluated separately. These variables had no associations with immune response and mean antibody titer (P > 0.05), however, the mean count of CD4+ cells higher than 200 cell/mm3 significantly affected mean antibody production one month and three months after the third vaccination.


Effects of Oral Levamisole as an Adjuvant to Hepatitis B Vaccine in HIV/ AIDS Patients: A Randomized Controlled Trial.

Sayad B, Alavian SM, Najafi F, Soltani B, Shirvani M, Janbakhsh A, Mansouri F, Afsharian M, Vaziri S, Alikhani A, Bashiri H - Hepat Mon (2012)

Trend of Antibody Production in the Experimental and Control Groups
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3475133&req=5

fig396: Trend of Antibody Production in the Experimental and Control Groups
Mentions: As shown, the level of immune response in the experimental group was significantly higher than in the controls, and this increased with repeated vaccination. Furthermore, the mean titer of HBsAb one month after the third vaccination was 56.05 IU/mL in the experimental group and 40.12 IU/mL in the control group, and three months after the third vaccination it had increased to 53.76 IU/mL and 45.15 IU/mL in the experimental and control groups, respectively (Figure 2). According to Figure 2, the mean antibody production in the experimental group was higher than the control group. The level of immune response one month after the first vaccination was 20.69% in the experimental group, and 34.38% in the controls (OR = 0.50, 95%CI: 0.16-1.6), at the same time, the mean antibody titer was 9.07 and 17.35 in the experimental and the control groups, respectively. The level of immune response two months after the second vaccination was 55% in the experimental group and 48.28% in the controls (OR = 1.31, 95% CI: 0.42-4.11) while the antibody titer was reported to be 38.85 and 36.01 in the experimental and control groups, respectively (Figure 1 and 2). None of the variables of age or body mass index had a significant association with antibody production (P > 0.05). Moreover, the effect of the study variables including; sex, age, body mass index, history of smoking, history of opium use, history of intravenous drug use, history of receiving antiretroviral drugs, and mean count of CD4+ cells, on the trend of immune response and mean antibody titer were evaluated separately. These variables had no associations with immune response and mean antibody titer (P > 0.05), however, the mean count of CD4+ cells higher than 200 cell/mm3 significantly affected mean antibody production one month and three months after the third vaccination.

Bottom Line: Since the immune response of HIV patients to hepatitis B vaccination is less robust than that found in healthy individuals, this study aimed to evaluate the effect of a levamisole adjuvant on increasing the immune response.The immune response and the mean titer of antibody were not associated with; age, sex, body mass index, history of smoking and/or intravenous drug use in either of the groups.However, regarding CD4+ cells more than 200 cell/mm3, mean antibody production significantly increased in both groups.

View Article: PubMed Central - PubMed

Affiliation: Liver Disease and Hepatitis Research Center, Kermanshah University of Medical Sciences, Kermanshah, IR Iran.

ABSTRACT

Background: Human immunodeficiency virus (HIV) infected patients are also frequently exposed to the hepatitis B virus (HBV), due to the common routes of transmission, therefore, prevention of hepatitis B results in decreased complications of the disease.

Objectives: Since the immune response of HIV patients to hepatitis B vaccination is less robust than that found in healthy individuals, this study aimed to evaluate the effect of a levamisole adjuvant on increasing the immune response.

Patients and methods: In this study, 89 HIV infected patients, without a history of HBV infection or vaccination, were randomly allocated into experimental (44 patients) and control (45 patients) groups. HBV vaccination was performed using the Hepavax-Gene TF vaccine, 40 μg three times at intervals of; zero, one, and three months. Levamisole 50 mg twice a day or a placebo, was administered to the experimental and control groups, respectively, for a period of six days before to six days after the vaccination. Immune response was evaluated by measuring hepatitis B surface antibodies (HBsAb) concurrently with the second and third vaccine administration, and at one and three months at the conclusion of the vaccination program.

Results: The immune response following the threevaccinations was higher in those who were receiving levamisole compared with the controls (90% vs. 65.38%) (P = 0.05). Furthermore, the immune response and the mean antibody titer following the repeated vaccination in the experimental group showed a higher increase than in the control group. The immune response and the mean titer of antibody were not associated with; age, sex, body mass index, history of smoking and/or intravenous drug use in either of the groups. However, regarding CD4+ cells more than 200 cell/mm3, mean antibody production significantly increased in both groups.

Conclusions: Using levamisole with the hepatitis B vaccination can increase the immune response and antibody titer mean in HIV infected patients. Since these patients have a more complete response with CD4+ cells more than 200 cell/mm3, vaccination and effective adjuvants seem to be most beneficial when CD4+ cells are greater than 200 cell/mm3, in HIV infected patients.

No MeSH data available.


Related in: MedlinePlus