Failure of therapeutic vaccination using hepatitis B surface antigen vaccine in the immunotolerant phase of children with chronic hepatitis B infection

[Guest guest]

Journal of Gastroenterology and Hepatology

Volume 18 Issue 2 Page 218 - February 2003

THERAPEUTIC VACCINE AGAINST HEPATITIS B INFECTION

Failure of therapeutic vaccination using hepatitis B surface antigen vaccine

in the immunotolerant phase of children with chronic hepatitis B infection

BUNYAMIN DIKICI*, MEHMET BOSNAK*, HASAN UCMAK, ABDULLAH DAGLI*, AYDIN ECE*

AND KENAN HASPOLAT*

Aim: The aim of this study was to investigate the efficacy of specific

hepatitis B virus (HBV) vaccination as active immunotherapy in treating

chronic hepatitis B (CHB) infection during the immune-tolerant phase in

children with normal aminotransferase levels and high viral load.

Methods: Fifty-one immunotolerant patients were randomly and prospectively

recruited into two groups. Group 1 included 23 patients that were vaccinated

with three standard injections of the GenHevac B vaccine in the deltoid or

quadricep muscle, initially, and at 30 days and 60 days, for specific

immunization. Group 2 contained 28 patients who did not receive any

medication or vaccination and were recruited as the control group.

Post-vaccination evaluation was performed at 6 months from the first

injection and at the end of the 12th month by serological and virological

analyses. A response criterion to therapy was defined as loss of HBV-DNA in

serum and hepatitis B early antigen (HBeAg) seroconversion (loss of HBeAg,

development of antibody to HBeAg (anti-HBe)).

Results: The mean alanine aminotransferase (ALT) value in group 1 at the

beginning of the vaccination was 33.6 ± 8.1 IU/L; this changed to 31.7 ± 9.0

IU/L at 6 months after first injection and 29.2 ± 7.1 IU/L at the end of 12

months (P> 0.05). In this group, mean HBV-DNA load at the starting point of

the vaccination was 3709 ± 1126 pg/mL; this value changed to 3569 ± 726

pg/mL at the sixth month and 3295 ± 832 pg/mL at the 12th month (P> 0.05).

In group 2, the mean ALT values at the beginning of therapy, and at the 6th

and 12th month were 32 ± 8 IU/L, 31.8 ± 8 IU/L, and 29.7 ± 7 IU/L,

respectively (P > 0.05), and the mean viral load of HBV-DNA values were 3827

± 1375 pg/mL, 3498 ± 886 pg/mL, and 3059 ± 731 pg/mL, respectively (P >

0.05). The load of HBV DNA of all patients in both groups was greater than

2000 pg/mL. There was no statistically significant difference in the mean

ALT values and mean viral load of HBV DNA (P> 0.05) between group 1 and

group 2 at the end of the 6th and 12th months. Except for one each patient

in each group, hepatitis B surface antigen (HBsAg) and HBeAg clearance or

antibody to HBsAg (anti-HBs) and anti-HBe seroconversion were not observed

during the follow-up period (P> 0.05).

Conclusion: In this study, comparison of vaccinated and unvaccinated groups

of immunotolerant children with CHB infection showed no difference in the

clearance of HBV DNA and seroconversion of HBeAg to anti-HBe. Different

immunization protocols should be considered for future investigations in the

immunotolerant phase of children with CHB infection

[Guest guest]

Journal of Gastroenterology and Hepatology

Volume 18 Issue 2 Page 218 - February 2003

THERAPEUTIC VACCINE AGAINST HEPATITIS B INFECTION

Failure of therapeutic vaccination using hepatitis B surface antigen vaccine

in the immunotolerant phase of children with chronic hepatitis B infection

BUNYAMIN DIKICI*, MEHMET BOSNAK*, HASAN UCMAK, ABDULLAH DAGLI*, AYDIN ECE*

AND KENAN HASPOLAT*

Aim: The aim of this study was to investigate the efficacy of specific

hepatitis B virus (HBV) vaccination as active immunotherapy in treating

chronic hepatitis B (CHB) infection during the immune-tolerant phase in

children with normal aminotransferase levels and high viral load.

Methods: Fifty-one immunotolerant patients were randomly and prospectively

recruited into two groups. Group 1 included 23 patients that were vaccinated

with three standard injections of the GenHevac B vaccine in the deltoid or

quadricep muscle, initially, and at 30 days and 60 days, for specific

immunization. Group 2 contained 28 patients who did not receive any

medication or vaccination and were recruited as the control group.

Post-vaccination evaluation was performed at 6 months from the first

injection and at the end of the 12th month by serological and virological

analyses. A response criterion to therapy was defined as loss of HBV-DNA in

serum and hepatitis B early antigen (HBeAg) seroconversion (loss of HBeAg,

development of antibody to HBeAg (anti-HBe)).

Results: The mean alanine aminotransferase (ALT) value in group 1 at the

beginning of the vaccination was 33.6 ± 8.1 IU/L; this changed to 31.7 ± 9.0

IU/L at 6 months after first injection and 29.2 ± 7.1 IU/L at the end of 12

months (P> 0.05). In this group, mean HBV-DNA load at the starting point of

the vaccination was 3709 ± 1126 pg/mL; this value changed to 3569 ± 726

pg/mL at the sixth month and 3295 ± 832 pg/mL at the 12th month (P> 0.05).

In group 2, the mean ALT values at the beginning of therapy, and at the 6th

and 12th month were 32 ± 8 IU/L, 31.8 ± 8 IU/L, and 29.7 ± 7 IU/L,

respectively (P > 0.05), and the mean viral load of HBV-DNA values were 3827

± 1375 pg/mL, 3498 ± 886 pg/mL, and 3059 ± 731 pg/mL, respectively (P >

0.05). The load of HBV DNA of all patients in both groups was greater than

2000 pg/mL. There was no statistically significant difference in the mean

ALT values and mean viral load of HBV DNA (P> 0.05) between group 1 and

group 2 at the end of the 6th and 12th months. Except for one each patient

in each group, hepatitis B surface antigen (HBsAg) and HBeAg clearance or

antibody to HBsAg (anti-HBs) and anti-HBe seroconversion were not observed

during the follow-up period (P> 0.05).

Conclusion: In this study, comparison of vaccinated and unvaccinated groups

of immunotolerant children with CHB infection showed no difference in the

clearance of HBV DNA and seroconversion of HBeAg to anti-HBe. Different

immunization protocols should be considered for future investigations in the

immunotolerant phase of children with CHB infection

[Guest guest]

Journal of Gastroenterology and Hepatology

Volume 18 Issue 2 Page 218 - February 2003

THERAPEUTIC VACCINE AGAINST HEPATITIS B INFECTION

Failure of therapeutic vaccination using hepatitis B surface antigen vaccine

in the immunotolerant phase of children with chronic hepatitis B infection

BUNYAMIN DIKICI*, MEHMET BOSNAK*, HASAN UCMAK, ABDULLAH DAGLI*, AYDIN ECE*

AND KENAN HASPOLAT*

Aim: The aim of this study was to investigate the efficacy of specific

hepatitis B virus (HBV) vaccination as active immunotherapy in treating

chronic hepatitis B (CHB) infection during the immune-tolerant phase in

children with normal aminotransferase levels and high viral load.

Methods: Fifty-one immunotolerant patients were randomly and prospectively

recruited into two groups. Group 1 included 23 patients that were vaccinated

with three standard injections of the GenHevac B vaccine in the deltoid or

quadricep muscle, initially, and at 30 days and 60 days, for specific

immunization. Group 2 contained 28 patients who did not receive any

medication or vaccination and were recruited as the control group.

Post-vaccination evaluation was performed at 6 months from the first

injection and at the end of the 12th month by serological and virological

analyses. A response criterion to therapy was defined as loss of HBV-DNA in

serum and hepatitis B early antigen (HBeAg) seroconversion (loss of HBeAg,

development of antibody to HBeAg (anti-HBe)).

Results: The mean alanine aminotransferase (ALT) value in group 1 at the

beginning of the vaccination was 33.6 ± 8.1 IU/L; this changed to 31.7 ± 9.0

IU/L at 6 months after first injection and 29.2 ± 7.1 IU/L at the end of 12

months (P> 0.05). In this group, mean HBV-DNA load at the starting point of

the vaccination was 3709 ± 1126 pg/mL; this value changed to 3569 ± 726

pg/mL at the sixth month and 3295 ± 832 pg/mL at the 12th month (P> 0.05).

In group 2, the mean ALT values at the beginning of therapy, and at the 6th

and 12th month were 32 ± 8 IU/L, 31.8 ± 8 IU/L, and 29.7 ± 7 IU/L,

respectively (P > 0.05), and the mean viral load of HBV-DNA values were 3827

± 1375 pg/mL, 3498 ± 886 pg/mL, and 3059 ± 731 pg/mL, respectively (P >

0.05). The load of HBV DNA of all patients in both groups was greater than

2000 pg/mL. There was no statistically significant difference in the mean

ALT values and mean viral load of HBV DNA (P> 0.05) between group 1 and

group 2 at the end of the 6th and 12th months. Except for one each patient

in each group, hepatitis B surface antigen (HBsAg) and HBeAg clearance or

antibody to HBsAg (anti-HBs) and anti-HBe seroconversion were not observed

during the follow-up period (P> 0.05).

Conclusion: In this study, comparison of vaccinated and unvaccinated groups

of immunotolerant children with CHB infection showed no difference in the

clearance of HBV DNA and seroconversion of HBeAg to anti-HBe. Different

immunization protocols should be considered for future investigations in the

immunotolerant phase of children with CHB infection

[Guest guest]

Journal of Gastroenterology and Hepatology

Volume 18 Issue 2 Page 218 - February 2003

THERAPEUTIC VACCINE AGAINST HEPATITIS B INFECTION

Failure of therapeutic vaccination using hepatitis B surface antigen vaccine

in the immunotolerant phase of children with chronic hepatitis B infection

BUNYAMIN DIKICI*, MEHMET BOSNAK*, HASAN UCMAK, ABDULLAH DAGLI*, AYDIN ECE*

AND KENAN HASPOLAT*

Aim: The aim of this study was to investigate the efficacy of specific

hepatitis B virus (HBV) vaccination as active immunotherapy in treating

chronic hepatitis B (CHB) infection during the immune-tolerant phase in

children with normal aminotransferase levels and high viral load.

Methods: Fifty-one immunotolerant patients were randomly and prospectively

recruited into two groups. Group 1 included 23 patients that were vaccinated

with three standard injections of the GenHevac B vaccine in the deltoid or

quadricep muscle, initially, and at 30 days and 60 days, for specific

immunization. Group 2 contained 28 patients who did not receive any

medication or vaccination and were recruited as the control group.

Post-vaccination evaluation was performed at 6 months from the first

injection and at the end of the 12th month by serological and virological

analyses. A response criterion to therapy was defined as loss of HBV-DNA in

serum and hepatitis B early antigen (HBeAg) seroconversion (loss of HBeAg,

development of antibody to HBeAg (anti-HBe)).

Results: The mean alanine aminotransferase (ALT) value in group 1 at the

beginning of the vaccination was 33.6 ± 8.1 IU/L; this changed to 31.7 ± 9.0

IU/L at 6 months after first injection and 29.2 ± 7.1 IU/L at the end of 12

months (P> 0.05). In this group, mean HBV-DNA load at the starting point of

the vaccination was 3709 ± 1126 pg/mL; this value changed to 3569 ± 726

pg/mL at the sixth month and 3295 ± 832 pg/mL at the 12th month (P> 0.05).

In group 2, the mean ALT values at the beginning of therapy, and at the 6th

and 12th month were 32 ± 8 IU/L, 31.8 ± 8 IU/L, and 29.7 ± 7 IU/L,

respectively (P > 0.05), and the mean viral load of HBV-DNA values were 3827

± 1375 pg/mL, 3498 ± 886 pg/mL, and 3059 ± 731 pg/mL, respectively (P >

0.05). The load of HBV DNA of all patients in both groups was greater than

2000 pg/mL. There was no statistically significant difference in the mean

ALT values and mean viral load of HBV DNA (P> 0.05) between group 1 and

group 2 at the end of the 6th and 12th months. Except for one each patient

in each group, hepatitis B surface antigen (HBsAg) and HBeAg clearance or

antibody to HBsAg (anti-HBs) and anti-HBe seroconversion were not observed

during the follow-up period (P> 0.05).

Conclusion: In this study, comparison of vaccinated and unvaccinated groups

of immunotolerant children with CHB infection showed no difference in the

clearance of HBV DNA and seroconversion of HBeAg to anti-HBe. Different

immunization protocols should be considered for future investigations in the

immunotolerant phase of children with CHB infection