Safety and Immunogenicity of an Inactivated Hepatitis A Vaccine among HIV-Infect

[Guest guest]

Clinical Infectious Diseases 2004;39:1207-1213

© 2004 by the Infectious Diseases Society of America. All rights reserved.

1058-4838/2004/3908-0017$15.00

HIV/AIDS MAJOR ARTICLE

Safety and Immunogenicity of an Inactivated Hepatitis A Vaccine among

HIV-Infected Subjects

Mark R. Wallace,1 Carolyn J. Brandt,1 C. Earhart,1 Barbara J.

Kuter,2 D. Grosso,2 Hassan Lakkis,2 and Sybil A. Tasker1

1Naval Medical Center San Diego, San Diego, California, and 2Merck, West

Point, Pennsylvania

Background. Hepatitis A is a major health risk for many human

immunodeficiency virus (HIV)infected individuals. Vaccination is a

potentially attractive measure to reduce the incidence of hepatitis A among

this population, but data on its safety and immunogenicity are incomplete.

Methods. Ninety HIV-uninfected adults received an inactivated

hepatitis A vaccine (VAQTA; Merck), and 90 HIV-infected subjects were

randomized, in double-blind fashion, to receive either the vaccine or

placebo. The HIV-infected subjects were stratified by CD4 cell count, with

45 subjects having CD4 cell counts of 300 cells/mm3 and 45 subjects having

CD4 cell counts of <300 cells/mm3. Vaccine was given at weeks 0 and 24 of

the study.

Results. Seroconversion rates at week 28 of the study were 94%

among the HIV-infected subjects and 100% among the HIV-uninfected control

subjects. HIV-infected subjects with CD4 cell counts of <300 cells/mm3 had a

seroconversion rate of 87%, and HIV-infected subjects with CD4 cell counts

of 300 cells/mm3 had a seroconversion rate of 100%. The vaccine was

generally well tolerated, and no adverse effect on either HIV load or CD4

cell count was found.

Conclusion. Hepatitis A vaccine was both immunogenic and safe among

HIV-infected subjects.

--------------------------------------------------------------------------------

Received 18 February 2004; accepted 2 June 2004; electronically

published 24 September 2004.

The views expressed in this article are those of the authors and do not

reflect the official policy or position of the US Department of the Navy,

the US Department of Defense, or the US government.

[Guest guest]

Clinical Infectious Diseases 2004;39:1207-1213

© 2004 by the Infectious Diseases Society of America. All rights reserved.

1058-4838/2004/3908-0017$15.00

HIV/AIDS MAJOR ARTICLE

Safety and Immunogenicity of an Inactivated Hepatitis A Vaccine among

HIV-Infected Subjects

Mark R. Wallace,1 Carolyn J. Brandt,1 C. Earhart,1 Barbara J.

Kuter,2 D. Grosso,2 Hassan Lakkis,2 and Sybil A. Tasker1

1Naval Medical Center San Diego, San Diego, California, and 2Merck, West

Point, Pennsylvania

Background. Hepatitis A is a major health risk for many human

immunodeficiency virus (HIV)infected individuals. Vaccination is a

potentially attractive measure to reduce the incidence of hepatitis A among

this population, but data on its safety and immunogenicity are incomplete.

Methods. Ninety HIV-uninfected adults received an inactivated

hepatitis A vaccine (VAQTA; Merck), and 90 HIV-infected subjects were

randomized, in double-blind fashion, to receive either the vaccine or

placebo. The HIV-infected subjects were stratified by CD4 cell count, with

45 subjects having CD4 cell counts of 300 cells/mm3 and 45 subjects having

CD4 cell counts of <300 cells/mm3. Vaccine was given at weeks 0 and 24 of

the study.

Results. Seroconversion rates at week 28 of the study were 94%

among the HIV-infected subjects and 100% among the HIV-uninfected control

subjects. HIV-infected subjects with CD4 cell counts of <300 cells/mm3 had a

seroconversion rate of 87%, and HIV-infected subjects with CD4 cell counts

of 300 cells/mm3 had a seroconversion rate of 100%. The vaccine was

generally well tolerated, and no adverse effect on either HIV load or CD4

cell count was found.

Conclusion. Hepatitis A vaccine was both immunogenic and safe among

HIV-infected subjects.

--------------------------------------------------------------------------------

Received 18 February 2004; accepted 2 June 2004; electronically

published 24 September 2004.

The views expressed in this article are those of the authors and do not

reflect the official policy or position of the US Department of the Navy,

the US Department of Defense, or the US government.

[Guest guest]

Clinical Infectious Diseases 2004;39:1207-1213

© 2004 by the Infectious Diseases Society of America. All rights reserved.

1058-4838/2004/3908-0017$15.00

HIV/AIDS MAJOR ARTICLE

Safety and Immunogenicity of an Inactivated Hepatitis A Vaccine among

HIV-Infected Subjects

Mark R. Wallace,1 Carolyn J. Brandt,1 C. Earhart,1 Barbara J.

Kuter,2 D. Grosso,2 Hassan Lakkis,2 and Sybil A. Tasker1

1Naval Medical Center San Diego, San Diego, California, and 2Merck, West

Point, Pennsylvania

Background. Hepatitis A is a major health risk for many human

immunodeficiency virus (HIV)infected individuals. Vaccination is a

potentially attractive measure to reduce the incidence of hepatitis A among

this population, but data on its safety and immunogenicity are incomplete.

Methods. Ninety HIV-uninfected adults received an inactivated

hepatitis A vaccine (VAQTA; Merck), and 90 HIV-infected subjects were

randomized, in double-blind fashion, to receive either the vaccine or

placebo. The HIV-infected subjects were stratified by CD4 cell count, with

45 subjects having CD4 cell counts of 300 cells/mm3 and 45 subjects having

CD4 cell counts of <300 cells/mm3. Vaccine was given at weeks 0 and 24 of

the study.

Results. Seroconversion rates at week 28 of the study were 94%

among the HIV-infected subjects and 100% among the HIV-uninfected control

subjects. HIV-infected subjects with CD4 cell counts of <300 cells/mm3 had a

seroconversion rate of 87%, and HIV-infected subjects with CD4 cell counts

of 300 cells/mm3 had a seroconversion rate of 100%. The vaccine was

generally well tolerated, and no adverse effect on either HIV load or CD4

cell count was found.

Conclusion. Hepatitis A vaccine was both immunogenic and safe among

HIV-infected subjects.

--------------------------------------------------------------------------------

Received 18 February 2004; accepted 2 June 2004; electronically

published 24 September 2004.

The views expressed in this article are those of the authors and do not

reflect the official policy or position of the US Department of the Navy,

the US Department of Defense, or the US government.

[Guest guest]

Clinical Infectious Diseases 2004;39:1207-1213

© 2004 by the Infectious Diseases Society of America. All rights reserved.

1058-4838/2004/3908-0017$15.00

HIV/AIDS MAJOR ARTICLE

Safety and Immunogenicity of an Inactivated Hepatitis A Vaccine among

HIV-Infected Subjects

Mark R. Wallace,1 Carolyn J. Brandt,1 C. Earhart,1 Barbara J.

Kuter,2 D. Grosso,2 Hassan Lakkis,2 and Sybil A. Tasker1

1Naval Medical Center San Diego, San Diego, California, and 2Merck, West

Point, Pennsylvania

Background. Hepatitis A is a major health risk for many human

immunodeficiency virus (HIV)infected individuals. Vaccination is a

potentially attractive measure to reduce the incidence of hepatitis A among

this population, but data on its safety and immunogenicity are incomplete.

Methods. Ninety HIV-uninfected adults received an inactivated

hepatitis A vaccine (VAQTA; Merck), and 90 HIV-infected subjects were

randomized, in double-blind fashion, to receive either the vaccine or

placebo. The HIV-infected subjects were stratified by CD4 cell count, with

45 subjects having CD4 cell counts of 300 cells/mm3 and 45 subjects having

CD4 cell counts of <300 cells/mm3. Vaccine was given at weeks 0 and 24 of

the study.

Results. Seroconversion rates at week 28 of the study were 94%

among the HIV-infected subjects and 100% among the HIV-uninfected control

subjects. HIV-infected subjects with CD4 cell counts of <300 cells/mm3 had a

seroconversion rate of 87%, and HIV-infected subjects with CD4 cell counts

of 300 cells/mm3 had a seroconversion rate of 100%. The vaccine was

generally well tolerated, and no adverse effect on either HIV load or CD4

cell count was found.

Conclusion. Hepatitis A vaccine was both immunogenic and safe among

HIV-infected subjects.

--------------------------------------------------------------------------------

Received 18 February 2004; accepted 2 June 2004; electronically

published 24 September 2004.

The views expressed in this article are those of the authors and do not

reflect the official policy or position of the US Department of the Navy,

the US Department of Defense, or the US government.