More, Higher Doses Boost Hep B Vax Response

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More, Higher Doses Boost Hep B Vax Response

This report is part of a 12-month Clinical Context series.

By a Fiore, Staff Writer, MedPage Today

Published: April 12, 2011

Reviewed by Jasmer, MD; Associate Clinical Professor of Medicine,

University of California, San Francisco and

Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Hepatitis B vaccination protocols involving more frequent or higher doses may be

more effective at producing virological response in HIV patients, researchers

say.

Both a high-dose, four-shot regimen given intramuscularly and a lower dose given

four times intradermally showed superior serological response compared with the

standard three-dose schedule, according to Odile Launay, MD, PhD, of Hopital

Cochin in Paris, and colleagues.

They reported their findings in the April 13 issue of the Journal of the

American Medical Association.

Guidelines recommend that all HIV patients who are negative for hepatitis B get

immunized. But for these patients, the immunogenicity of the shot is variable,

and tends to be lower than in healthy adults.

Action Points

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

â– Explain that hepatitis B vaccination protocols involving more frequent or

higher doses than the standard vaccination schedule may be more effective at

producing virological response in HIV patients.

â– Note that patients in the high-dose group had a higher rate of fever, nausea,

or edema, and those in the low-dose group had a higher rate of local adverse

reactions.

So the researchers investigated whether two different protocols for delivering

vaccine in this population could improve immunogenicity, via an open-label,

multicenter, parallel-group, randomized trial conducted between June 28, 2007

and Oct. 23, 2008.

The study was done at 33 centers in France among patients enrolled in the French

National Agency for Research on AIDS and Viral Hepatitis trials, in adults with

HIV-1 infection who were free of hepatitis B and had CD4 cell counts of more

than 200 cells/microliter.

Ultimately, 437 patients were randomized to one of three scenarios -- three

intramuscular shots of the standard dose (20 mcg), four double-dose

intramuscular shots (40 mcg), or four low-dose intradermal shots (4 mcg).

The researchers found that by week 28, significantly more patients had responded

to the four-dose regimens:

•65% of those responded in the three-dose group

•82% of those responded in the high-dose group (P<0.001);

•77% of those responded in the low-dose group (P=0.02)

A high-level response was achieved in 41% of those on the standard protocol,

compared with 74% of high-dose participants and 53% of low-dose.

At 28 weeks, mean antibody titers were 55 mIU/mL, 795 mIU/mL, and 104 mIU/mL,

respectively.

They noted that for those on the high-dose regimen, significant increases in

response rate were observed just one month after the last dose of the vaccine,

and they also achieved a high seroconversion rate as soon as 12 weeks, compared

with the standard protocol.

Thus, they said that " in real life, " even without completing a four-dose

regimen, good levels of protection could still be achieved.

The researchers added that they saw no safety signals, although patients in the

high-dose group had a higher rate of fever, nausea, or edema, and those in the

low-dose group had a higher rate of local adverse reactions.

The study was limited because it did not evaluate protection against hepatitis B

infection, nor did it assess long-term protection.

Still, Launay and colleagues concluded that the results are in agreement with

recent pilot studies, and that the more frequent protocols for both the

high-dose intramuscular shot and the low-dose intradermal shot " improved

serological response in comparison with the standard schedule of the hepatitis B

vaccine in HIV patients. "

The study was supported by the French National Agency for Research on AIDS and

Viral Hepatitis.

Sanofi Pasteur-MSD provided the vaccine used in the study.

Launay reported relationships with Sanofi Pasteur-MSD.

Co-authors reported relationships with Sanofi Pasteur-MSD, GlaxoKline,

Gilead, Bristol-Myers Squibb, Wyeth, Pfizer, Astellas, Gilead, Schering Plough,

and Novartis.

Primary source: Journal of the American Medical Association

Source reference:

Launay O, et al " Safety and immunogenicity of four intramuscular double doses

and four intradermal low doses versus standard hepatitis B vaccine regimen in

adults with HIV-1 " JAMA 2011; 305(14): 1432-1440.

[Guest guest]

http://www.medpagetoday.com/clinical-context/HIVAIDS/25866?utm_content= & utm_medi\

um=email & utm_campaign=DailyHeadlines & utm_source=WC & userid=23283

More, Higher Doses Boost Hep B Vax Response

This report is part of a 12-month Clinical Context series.

By a Fiore, Staff Writer, MedPage Today

Published: April 12, 2011

Reviewed by Jasmer, MD; Associate Clinical Professor of Medicine,

University of California, San Francisco and

Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Hepatitis B vaccination protocols involving more frequent or higher doses may be

more effective at producing virological response in HIV patients, researchers

say.

Both a high-dose, four-shot regimen given intramuscularly and a lower dose given

four times intradermally showed superior serological response compared with the

standard three-dose schedule, according to Odile Launay, MD, PhD, of Hopital

Cochin in Paris, and colleagues.

They reported their findings in the April 13 issue of the Journal of the

American Medical Association.

Guidelines recommend that all HIV patients who are negative for hepatitis B get

immunized. But for these patients, the immunogenicity of the shot is variable,

and tends to be lower than in healthy adults.

Action Points

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

â– Explain that hepatitis B vaccination protocols involving more frequent or

higher doses than the standard vaccination schedule may be more effective at

producing virological response in HIV patients.

â– Note that patients in the high-dose group had a higher rate of fever, nausea,

or edema, and those in the low-dose group had a higher rate of local adverse

reactions.

So the researchers investigated whether two different protocols for delivering

vaccine in this population could improve immunogenicity, via an open-label,

multicenter, parallel-group, randomized trial conducted between June 28, 2007

and Oct. 23, 2008.

The study was done at 33 centers in France among patients enrolled in the French

National Agency for Research on AIDS and Viral Hepatitis trials, in adults with

HIV-1 infection who were free of hepatitis B and had CD4 cell counts of more

than 200 cells/microliter.

Ultimately, 437 patients were randomized to one of three scenarios -- three

intramuscular shots of the standard dose (20 mcg), four double-dose

intramuscular shots (40 mcg), or four low-dose intradermal shots (4 mcg).

The researchers found that by week 28, significantly more patients had responded

to the four-dose regimens:

•65% of those responded in the three-dose group

•82% of those responded in the high-dose group (P<0.001);

•77% of those responded in the low-dose group (P=0.02)

A high-level response was achieved in 41% of those on the standard protocol,

compared with 74% of high-dose participants and 53% of low-dose.

At 28 weeks, mean antibody titers were 55 mIU/mL, 795 mIU/mL, and 104 mIU/mL,

respectively.

They noted that for those on the high-dose regimen, significant increases in

response rate were observed just one month after the last dose of the vaccine,

and they also achieved a high seroconversion rate as soon as 12 weeks, compared

with the standard protocol.

Thus, they said that " in real life, " even without completing a four-dose

regimen, good levels of protection could still be achieved.

The researchers added that they saw no safety signals, although patients in the

high-dose group had a higher rate of fever, nausea, or edema, and those in the

low-dose group had a higher rate of local adverse reactions.

The study was limited because it did not evaluate protection against hepatitis B

infection, nor did it assess long-term protection.

Still, Launay and colleagues concluded that the results are in agreement with

recent pilot studies, and that the more frequent protocols for both the

high-dose intramuscular shot and the low-dose intradermal shot " improved

serological response in comparison with the standard schedule of the hepatitis B

vaccine in HIV patients. "

The study was supported by the French National Agency for Research on AIDS and

Viral Hepatitis.

Sanofi Pasteur-MSD provided the vaccine used in the study.

Launay reported relationships with Sanofi Pasteur-MSD.

Co-authors reported relationships with Sanofi Pasteur-MSD, GlaxoKline,

Gilead, Bristol-Myers Squibb, Wyeth, Pfizer, Astellas, Gilead, Schering Plough,

and Novartis.

Primary source: Journal of the American Medical Association

Source reference:

Launay O, et al " Safety and immunogenicity of four intramuscular double doses

and four intradermal low doses versus standard hepatitis B vaccine regimen in

adults with HIV-1 " JAMA 2011; 305(14): 1432-1440.