ANTHC :: Hepatitis B Intradermal Vaccine Protocol

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Protocol for Immunization with High-Dose Intradermal Recombinant Hepatitis B Vaccine for Documented Nonresponders

Background

Healthcare workers (HCW) are at risk for occupational exposure to hepatitis B. This risk is particularly acute in HCWs with frequent exposure to body fluids. Hepatitis B vaccine has been licensed in the United States since 1981. In 1981, the Indian Health Service (IHS) began giving the vaccine in selected villages and to HCWs.¹ The Occupational Safety and Health Administration mandated that hepatitis B vaccine be offered to all HCWs employed in job categories having a reasonable expectation of occupational exposure to potentially infectious materials.² However, despite widespread use of hepatitis B vaccine, approximately 12% of HCWs fail to develop protective antibody titers after the recommended three-dose intramuscular series.^3,4 In the original study evaluating the plasma-derived vaccine, subjects who did not develop protective levels of antibody to hepatitis B virus (ie, nonresponders: post-hepatitis B vaccine HBsAb <10mIU/ml) were at risk, and some indeed later developed acute, symptomatic hepatitis B.⁵ Multiple investigators have emphasized that risk factors for failure to develop adequate levels of antibodies include increasing age, smoking and obesity.^2,3,6,7

Our current recommended follow-up of those HCWs who are nonresponders to the hepatitis B vaccine after the three-dose series is to give a fourth dose of hepatitis B vaccine followed by a blood test for HBsAb in one to two months. If HBsAb result is <10mIU/ml, the HCW is counseled about being a nonresponder.⁸ Another option is to repeat the series, three vaccine doses and a blood test (HBsAb) one to two months after the sixth dose of vaccine. However, this strategy is unsuccessful in at least 50% of HCWs.⁹ A higher degree of success can be achieved by using a high-dose intradermal method.¹⁰

Objective

Administer hepatitis B vaccine intradermally to documented nonresponders with the end point development of hepatitis B antibody (HBsAb). Using the following high-dose intradermal method with the goal of an HBsAb >10mIU/ml.

Method/Procedure

Referral of HCWs to the Liver Clinic after failure to respond to three dose hepatitis B vaccine.
Liver Clinic staff will review the HCW?s hepatitis B history to establish eligibility and after failure to respond following fourth dose of vaccine IM.
Week 0: give adult hepatitis B vaccine 0.25cc intradermal in forearm
Week 2: give adult hepatitis B vaccine 0.25cc intradermal in other forearm
Week 4: draw HBsAb (post hepatitis B vaccine)
HBsAb Positive = Immune, no further vaccine
HBsAb Negative = repeat steps 3, 4, 5¹⁰
If HBsAb negative after second series of intradermal hepatitis B vaccine refer to Employee Health for counseling

Reference:

1.Wainwright RB, McMahon BJ, et al. Duration of Immunogenicity and Efficacy of Hepatitis B Vaccine in a Yupik Eskimo Population. JAMA 1989;261:2362-2366.

2. Department of Labor, Occupational Safety and Health Administration. Occupational Exposure to Bloodborne pathogens: Rules and Regulations. Federal Register 1991;56;64004-64182.

3. Wood RC, MacDonald KL, White KE, Hedberg CW, Hanson M, Osterholm MT. Risk factors for lack of detectable antibody following hepatitis B vaccination of Minnesota health care workers. JAMA 1993;270:2935-2939.

4. Roome AJ, Walsh SJ, Carter ML, Hadler JL. Hepatitis B vaccine responsiveness in Connecticut public safety personnel. JAMA 1993;270:2931-2934.

5. Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccine demonstrations of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med 1980;303:833-841.

6. Shaw FE Jr, Guess HA, Roets JM, et al. Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination. Vaccine 1989;7:425-430.

7. Weber DF, Rutala WA, Samsa GP, Santimaw JE, Lemon SM. Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine. JAMA 1985;254:3187-3189.

8. MMWR 12/26/1997;Vol.46;No.RR-18.

9. Weissman JY, Tsuchiyose MM, Tong MJ, et al. Lack of response to recombinant hepatitis B vaccine in nonresponders to the plasma vaccine. JAMA 1988;260:1734-1738.

10.Levitz RE, Cooper BW, Regan HC. Immunization with high-dose intradermal recombinant hepatitis B vaccine in health care workers who failed to respond to intramuscular vaccination. IC and H Epidemiology 1995;16:88-90.

Revision: 3.2001