HBV Vaccine Dose Offers More Protection for People with HIV
Two alternative dosing schedules of hepatitis B virus
(HBV) vaccination led to higher levels of protection than
the standard 3-dose schedule.
People living with HIV
are known to be less likely to achieve immunological response
to standard hepatitis B vaccination. People coinfected
with HIV and HBV have an increased risk of liver injury
and mortality compared to people with only HBV.
People with HIV need HBV vaccination strategies that are both
safe and more effective to reduce their risk of liver disease
Launay and fellow investigators with the ANRS HB03 VIHVAC-B
Trial reported in the April 13, 2011, Journal of the American
Medical Association on a study comparing 2 alternative
dosing schedules to the standard HBV vaccination regimen.
study included 437 people with HIV at 33 centers in France;
37% were women, and the average age was just over 40 years.
Participants were randomized in a 1:1:1 fashion to receive
one of 3 dosing schedules of recombinant HBV vaccine:
double-dose (40 mcg) intramuscular (IM) injections at
weeks 0, 4, 8, and 24;
low-dose (4 mcg) intradermal (ID) injections at weeks
0, 4, 8, and 24;
standard-dose (20 mcg) IM injections at weeks 0, 4, and
primary endpoint was percentage of patients who produced an
antibody response after 28 weeks, defined as HBV surface antibody
(anti-HBs) titer of at least 10 mIU/mL. The dosing schedules
were also assessed for safety.
28 weeks, 65% of patients receiving the standard-dose
IM schedule produced an immune response.
of patients on the 4 times double-dose IM schedule had
an immune response, a statistically significant difference
compared to the standard dose schedule.
of patients on the 4 times low-dose ID schedule had an
immune response, again significant compared to the standard
antibody titers at 28 weeks were 55 mIU/mL, 795 mIU/mL,
and 104 mIU/mL, respectively.
as many people in the 4 times double-dose IM arm discontinued
vaccination prematurely compared to the other schedules
(8% vs 4% vs 4%).
markers of safety were similar across the 3 dose groups.
findings indicate that either of the alternative hepatitis
B vaccination dosing schedules assessed in this study is more
likely than the standard schedule to produce effective immunity
against HBV. Moreover, both alternative schedules were found
to be safe.
recommend that all people with HIV should be vaccinated against
hepatitis B if they are not already immune. This study suggests
that these 2 alternative dosing schedules are good candidates
to help decrease the incidence of HBV infection in people
with HIV, and therefore reduce the likelihood of liver-related
disease and death.
affiliations: Paris Descartes University; Assistance Publique
Hôpitaux de Paris, Cochin Hospital, Paris, France; Inserm
CICBT505, Paris, France; Pasteur Institut and Inserm U845,
Paris, France; University Hospital and Bourgogne University,
Dijon, France; University Hospital, Strasbourg, France; Assistance
Publique Hôpitaux de Paris, Saint-Louis Hospital, Paris,
France; Assistance Publique Hôpitaux de Paris, Tenon
Hospital, Paris, France; Inserm U707, Paris, France; Assistance
Publique Hôpitaux de Paris, Necker-Enfants Malades Hospital,
Paris, France; Pierre et Marie Curie University, UMR-S 707,
and Assistance Publique Hôpitaux de Paris, Saint Antoine
Hospital, Paris, France.
O Launay, D van der Vliet, AR Rosenberg, et al. Safety and
Immunogenicity of 4 Intramuscular Double Doses and 4 Intradermal
Low Doses vs. Standard Hepatitis B Vaccine Regimen in Adults
With HIV-1. Journal of the American Medical Association
April 13, 2011.