From the Guidelines
The recommended dose of Hepatitis B (HBV) recombinant vaccine for adults is 10 μg administered intramuscularly as a three-dose series for Recombivax HB, with a dose volume of 1 mL. The standard schedule consists of the initial dose, followed by a second dose 1 month later for some schedules, and a third dose 6 months after the first dose for the standard schedule. The vaccine should be injected into the deltoid muscle (upper arm) for adults, not in the buttocks as this can reduce effectiveness. For certain populations, such as immunocompromised individuals or those on dialysis, a higher dose formulation (40 μg) may be recommended, as seen with Recombivax HB for adults on hemodialysis and other immunocompromised adults aged ≥20 years, which is administered as a 3-dose series 1. If the vaccination schedule is interrupted, it's not necessary to restart the series; simply continue where you left off. Protection is achieved after completing all three doses, with over 90% of healthy adults developing protective antibodies. The vaccine works by introducing a small amount of HBV surface antigen protein (not live virus) that triggers the immune system to produce antibodies against the hepatitis B virus, providing long-term protection against this serious liver infection. Key considerations include:
- The dose and schedule may vary based on the specific vaccine product used, such as Engerix-B or Heplisav-B, with different dose volumes and schedules applicable for each product 1.
- Certain populations may require special consideration, including those with immunocompromised status or on dialysis, who may benefit from higher dose formulations or alternative schedules 1.
- The vaccine's effectiveness can be influenced by factors such as age, smoking status, and obesity, emphasizing the importance of following recommended vaccination schedules and doses to achieve optimal protection 1.
From the FDA Drug Label
The adult formulation contains 20 mcg of hepatitis B surface antigen adsorbed on 0.5 mg aluminum as aluminum hydroxide. The recommended dose of Hepatitis B (HBV) virus recombinant vaccine for adults is 20 mcg. 2
From the Research
Hepatitis B Virus Recombinant Vaccine Dosage for Adults
The recommended dose of Hepatitis B (HBV) virus recombinant vaccine for adults varies depending on the specific vaccine and the individual's health status.
- A study published in 1996 found that a 20-microgram dose of a recombinant hepatitis B vaccine administered at 0,1, and 6 months was effective in inducing an immune response in healthy adults 3.
- Another study published in 1998 compared the efficacy of two surface subunit recombinant hepatitis B vaccines with a surface and PreS subunit vaccine and found that all three vaccines were effective in inducing an immune response in healthy adults, with a dose of 20 micrograms administered at 0,1, and 2 months 4.
- A study published in 2011 used a hepatitis B recombinant DNA vaccine, HBvaxPRO, at a dose of 40 µg intramuscularly using a four-dose schedule at 0,1,2, and 12 months and found that 82% of patients achieved immunity 5.
- A study published in 1997 found that a 5 micrograms dose of recombinant hepatitis B vaccine was effective as a booster dose in adults who had previously been immunized with three doses of vaccine 6.
- Additionally, a study published in 1985 found that a low-dose intradermally administered hepatitis B virus vaccine, with a dose of 2 micrograms administered at 0,30, and 180 days, was immunogenic in healthy adults 7.