Hepatitis B Vaccines

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Indications

The national strategy to eliminate HBV transmission in the United States focuses on four major categories of subjects, including: (1) neonates, (2) infants, (3) adolescents, and (4) adults who are at increased risks for infection [6]. Identification of pregnant women who test positive for hepatitis B surface antigen (HBsAg) and timely postexposure prophylaxis of their newborns with hepatitis B vaccine can prevent most perinatal transmission [7]. Hepatitis B vaccine is now recommended for all

Prevaccination screening and isolated antibody to hepatitis B core antigen

Prevaccination screening may be cost effective when the expected prevalence of prior HBV infection exceeds 30% [10], such as in the high-risk adult populations for whom hepatitis B vaccine is indicated. Occasionally potential recipients of hepatitis B vaccine test positive for antibody to hepatitis B core antigen (anti–HBc) but negative for both HBsAg and anti–HBs. Isolated anti–HBc may be found due to suppression of HBV replication by hepatitis C virus in co-infected patients [21], [22], or in

Immunogenicity

The HBsAg particle is the immunogen in both plasma-derived and recombinant hepatitis B vaccines. This envelope protein composed of several allelic subtype determinants but only one common group-specific determinant “a,” which allows cross-protectivity among different subtypes [28], [29]. Vaccinated subjects may have transiently detectable HBsAg in the serum within the first 24 hours. HBV vaccines stimulate active synthesis of anti–HBs conferring immunity. The first commercially available

Routes of vaccine administration

Hepatitis B vaccine is traditionally administered intramuscularly, using a needle of 1.0 to 1.5 inches in length and 20- to 25-gauge in caliber. The preferred injection site is the deltoid muscle in adults and anterolateral thigh muscle in infants. Among 194 health care workers who received intramuscular buttock injections of hepatitis B vaccination, only 58% subsequently developed detectable anti–HBs titers [36]. This finding was verified by a prospective randomized trial where health care

Predictors of nonresponse

An anti–HBs level of ≥ 10 mIU/mL is regarded as a protective serum titer. Patients with certain clinical characteristics may have a lesser chance to sero-convert than others. In a retrospective multicenter cohort study of nearly 600 health care workers who underwent postvaccination testing for anti–HBs within 6 months after completion of vaccine series, five independent variables were identified by multivariate analysis as adverse prognostic factors for sero-conversion [45], These predictors

Efficacy of hepatitis B vaccines

Seroprotective rate up to 95% or above has been demonstrated in multiple placebo-controlled, randomized double-blind trials involving health care workers [29] and homosexual males [54], [55], [56]. This is defined as percentage of vacinees achieving an anti-HBs titer > 10 mIU/mL. Infection rates in reported studies were <4% among the vaccinees, in contrast with rates of 10% to 27% in the placebo arms. A significant reduction of hepatitis B cases within 75 days after randomization of subjects

Vaccine nonresponse and its management

Among individuals who do not respond to the initial series of hepatitis B vaccine, half may convert after an additional one to three doses [60], [85]. Hypo-responders are more likely to seroconvert than nonresponders [86]. The use of investigational mix-particle vaccines containing pre-Sl, pre-S2, and S subunits does not enhance the seroconversion rate achieved by a standard S-unit vaccine of equivalent dosage [87]. Likewise, doubling administered doses for revaccination does not confer any

Adverse effects of hepatitis B vaccines

Both plasma and recombinant vaccines are equally well tolerated [5], [10], [102]. Transient tenderness or pain may occur in up to a fifth of the vaccinees. Low-grade fever is found in < 5% of the cases. Other much less common adverse events, including fatigue, headache, malaise, nausea, dizziness, skin rash, arthralgia, myalgia, and respiratory distress, occur in < 1% of cases [5], [103]. Anaphy-laxis may rarely occur, and epinephrine should be available for immediate use [10]. Among 850,000

Immunotherapy using hepatitis B vaccine

Hepatitis B vaccine may serve as an immunomodulator for suppressing viral replication. In a study of the therapeutic efficacy of hepatitis B vaccine, 118 treatment-naïve patients with histologically and virologically proven chronic hepatitis B were randomized to receive either placebo or intramuscular hepatitis B vaccine in the form of S vaccine alone or combined pre-S2 and S vaccine [106]. After five vaccine injections were given, there was a significant but transient 6-month decrease in viral

Summary

Immunization is the most effective way to prevent transmission of HBV and, hence, the development of acute or chronic hepatitis B. The national strategy to eliminate transmission of the virus in the United States includes vaccination of all newborn infants, children, adolescents, and high-risk adults. Postexposure prophylaxis is also advocated, depending on the vaccination and anti–HBs status of the exposed person. Seroprotection after vaccination, defined as anti–HBs ≥ 10 mIU/mL, is achieved

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    A version of this article originally appeared in the 8:2 issue of Clinics in Liver Disease.

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