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Additional 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 and death.

Odile 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.

The 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:

• 4 double-dose (40 mcg) intramuscular (IM) injections at weeks 0, 4, 8, and 24;
• 4 low-dose (4 mcg) intradermal (ID) injections at weeks 0, 4, 8, and 24;
• 3 standard-dose (20 mcg) IM injections at weeks 0, 4, and 24.

The 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.

Results

• After 28 weeks, 65% of patients receiving the standard-dose IM schedule produced an immune response.
• 82% of patients on the 4 times double-dose IM schedule had an immune response, a statistically significant difference compared to the standard dose schedule.
• 77% of patients on the 4 times low-dose ID schedule had an immune response, again significant compared to the standard schedule.
• Mean antibody titers at 28 weeks were 55 mIU/mL, 795 mIU/mL, and 104 mIU/mL, respectively.
• Twice as many people in the 4 times double-dose IM arm discontinued vaccination prematurely compared to the other schedules (8% vs 4% vs 4%).
• Other markers of safety were similar across the 3 dose groups.

These 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.

Guidelines 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.

Investigator 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.

4/23/11

Reference
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 305(14):1432-1440 (abstract). April 13, 2011.