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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 Immune Response in the Experimental and Control Groups
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fig395: Trend of Immune Response in the Experimental and Control Groups

Mentions: Among the 150 patients referred to the center during a period of 24 months (from April 2008 until April 2010), 89 patients met the inclusion criteria, and these individuals were randomly entered into the experimental (44 patients) and control (45 patients) groups, respectively. Table 1 shows the demographic data and the distribution of the variables in each of the groups. According to the table, the two groups were comparable regarding; age, sex, body mass index, history of smoking, history of using opium, history of intravenous drug use, mean count of CD4+ cells as well as antiretroviral treatment (Table 1). The second vaccination was administered to a total of 61 patients, this was because 28 individuals did not wish to continue their participation, and they did not have the second vaccination. For the third vaccination, only 49 patients received the vaccine as; four patients had died, two patients had emigrated from Kermanshah Province and six did not desire to continue their participation. Among the 49 individuals receiving all three of the vaccinations, 43 patients were referred for the first measurement of HBsAb titer, while the final (second) titration of HBsAb was performed on 46 patients. The percentage of immune response (HBsAb ≥ 10 IU/mL) and mean titer of HBsAb during the three vaccination times in the experimental and control groups are summarized in Tables 2 and 3. The level of immune response one month after the third vaccination in the experimental group (who received levamisole adjuvant) and the controls (who received placebo) showed an 84.21% and 58.33% increase, respectively. However, three months after the third vaccination, immune response had increased to 90% in the experimental group and 65.38% in the controls (P = 0.05) (Figure 1). The calculated number-needed-to treat for three months after the third vaccination is equal to 4.


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 Immune Response in the Experimental and Control Groups
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig395: Trend of Immune Response in the Experimental and Control Groups
Mentions: Among the 150 patients referred to the center during a period of 24 months (from April 2008 until April 2010), 89 patients met the inclusion criteria, and these individuals were randomly entered into the experimental (44 patients) and control (45 patients) groups, respectively. Table 1 shows the demographic data and the distribution of the variables in each of the groups. According to the table, the two groups were comparable regarding; age, sex, body mass index, history of smoking, history of using opium, history of intravenous drug use, mean count of CD4+ cells as well as antiretroviral treatment (Table 1). The second vaccination was administered to a total of 61 patients, this was because 28 individuals did not wish to continue their participation, and they did not have the second vaccination. For the third vaccination, only 49 patients received the vaccine as; four patients had died, two patients had emigrated from Kermanshah Province and six did not desire to continue their participation. Among the 49 individuals receiving all three of the vaccinations, 43 patients were referred for the first measurement of HBsAb titer, while the final (second) titration of HBsAb was performed on 46 patients. The percentage of immune response (HBsAb ≥ 10 IU/mL) and mean titer of HBsAb during the three vaccination times in the experimental and control groups are summarized in Tables 2 and 3. The level of immune response one month after the third vaccination in the experimental group (who received levamisole adjuvant) and the controls (who received placebo) showed an 84.21% and 58.33% increase, respectively. However, three months after the third vaccination, immune response had increased to 90% in the experimental group and 65.38% in the controls (P = 0.05) (Figure 1). The calculated number-needed-to treat for three months after the third vaccination is equal to 4.

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