How long does a Hepatitis B (HepB) vaccine provide immunity?

From the Guidelines

The Hepatitis B vaccine provides long-term immunity, typically lasting for at least 30 years and possibly for life in most individuals who complete the full vaccination series. The standard HepB vaccination schedule consists of three doses: the initial dose, followed by a second dose 1 month later, and a third dose 6 months after the first. For most healthy individuals who receive all three doses, routine booster shots are not recommended as studies have shown that protective antibody levels may decline over time but immune memory remains intact, providing continued protection against infection 1.

Key Points to Consider

• The vaccine works by stimulating the immune system to produce antibodies against the hepatitis B surface antigen, creating immune memory cells that can rapidly respond if exposed to the actual virus in the future.
• Certain high-risk groups such as healthcare workers, dialysis patients, and immunocompromised individuals may need periodic antibody testing and booster doses if their antibody levels fall below protective thresholds.
• Approximately 16% of persons vaccinated at age <1 year have antibody levels of ≥10 mIU/mL 18 years following vaccination, compared with 74% for those vaccinated at age ≥1 year 1.
• Most persons (88%) who receive a challenge dose of HepB vaccine 30 years after HepB vaccination as children or adults develop an antibody response of ≥10 mIU/mL indicating persistent immunity to HBV infection 1.

Duration of Immunity

Protection against symptomatic and chronic HBV infection has been documented to persist for ≥22 years in vaccine responders 1. Immunocompetent persons who achieve hepatitis B surface antibody (anti-HBs) concentrations of ≥10 mIU/mL after preexposure vaccination have protection against both acute disease and chronic infection. Although immunogenicity is lower among immunocompromised persons, those who achieve and maintain a protective antibody response before exposure to HBV have a high level of protection from infection 1.

Booster Shots

Routine booster shots are not recommended for most healthy individuals who receive all three doses of the HepB vaccine, as the immune memory remains intact, providing continued protection against infection 1. However, certain high-risk groups may need periodic antibody testing and booster doses if their antibody levels fall below protective thresholds.

From the FDA Drug Label

Immunization with 10 mcg at 0,1, and 2 months of age produced a seroprotection rate of 96% in infants by month 4, with a GMT among seroconverters of 210 mIU/mL (N = 311); an additional dose at month 12 produced a GMT among seroconverters of 2,941 mIU/mL at month 13 (N = 126)

In a separate clinical trial including both children and adolescents aged 5 to 16 years, 10 mcg of ENGERIX-B was administered at 0,1, and 6 months (N = 181) or 0,12, and 24 months (N = 161).

Immunogenicity in Healthy Adults and Adolescents: Clinical trials in healthy adult and adolescent subjects have shown that following a course of 3 doses of 20 mcg ENGERIX-B given according to the ACIP-recommended schedule of injections at months 0,1, and 6, the seroprotection (antibody titers ≥10 mIU/mL) rate for all individuals was 79% at month 6 and 96% at month 7;

On an alternate schedule (injections at months 0,1, and 2) designed for certain populations (e.g., neonates born of hepatitis B–infected mothers, individuals who have or might have been recently exposed to the virus, and certain travelers to high-risk areas. See INDICATIONS AND USAGE), 99% of all individuals were seroprotected at month 3 and remained protected through month 12

The Hepatitis B (HepB) vaccine provides immunity for at least 12 months after the last dose in certain populations, such as those who receive an additional dose at 12 months. However, the duration of immunity is not explicitly stated for all populations and schedules.

• Key factors that influence the duration of immunity include the vaccine schedule, dose, and population being vaccinated.
• Available data suggest that the vaccine provides seroprotection for at least 12 months in some cases, but the long-term duration of immunity is not clearly defined 2.

From the Research

Duration of Immunity Provided by HepB Vaccine

The duration of immunity provided by the Hepatitis B (HepB) vaccine is a topic of interest, with various studies investigating its long-term protection.

• A study published in 2019 3 found that 90.1% of participants had HBsAg-specific antibodies concentrations ≥ 10 mIU/mL 20-30 years after primary vaccination, suggesting sustained immune memory and long-term protection.
• Another study from 1987 4 reported that 87% of vaccinees had a favorable anti-HBs response one year after primary immunization, and a booster dose induced an anamnestic response in 90% of vaccinees by two weeks.
• The duration of immunity following vaccination has not yet been defined, but booster dose guidelines for selected groups are provided 5.
• A more recent study from 2022 6 estimated that 86% of participants had evidence of protection 35 years after primary vaccination, with 73.7% responding to a booster dose with an anti-HBs level ≥ 10 mIU/ml at 30 days.
• The role of vaccine immunogenicity in immune memory is crucial for lifelong protection against hepatitis B, with studies revealing links between specific lymphoproliferation, the in vivo humoral response, and immune memory 7.

Key Findings

• The HepB vaccine provides long-term protection, with studies showing immunity lasting 20-35 years after primary vaccination 3, 6.
• Booster doses may not be needed in the general population, but may be necessary for certain individuals 4, 6.
• The strength of immune memory and subsequent secondary immune response can be predicted by the antibody response following primary vaccination 7.
• Vaccine antigen dose and structure are important influences in the primary antibody response and development of immune memory 7.