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Immune Response and Histologic Evaluation of Injection Sites

Jessica A. Clarke, MD, PhD; F. Blaine Hollinger, MD; Ernest Lewis, MD; Liisa A. Russell, MD; Claramae H. Miller, PhD; Art Huntley, MD; Neil M. Flynn, MD

JAMA. 1989;262(18):2567-2571.

Abstract
The high cost of hepatitis B vaccine has limited its widespread use. Low-dose, intradermal injections of vaccine represent one option for reducing the cost. In this study, 92 nonimmune medical students were given three 0.1-mL intradermal injections of Heptavax-B containing 2 µg of hepatitis B surface antigen (HBsAg) at 0,1, and 6 months. By 6 months, 90% of the subjects had developed protective levels of antibody to HBsAg (10 mlU/mL). Follow-up at 1 year showed a geometric mean concentration of antibodies to HBsAg of 396 mlU/mL for the group, and 95% had levels of antibody to HBsAg greater than or equal to 10 mlU/mL. A level of antibody to HBsAg of greater than 100 mlU/mL also was observed in more than 75% of subjects. Side effects included induration of the inoculation site in 18% at 6 months, which disappeared by 12 months, and macules that persisted at 1 year in 63%. The administration of hepatitis B vaccine intradermally is an attractive, low-cost alternative in the United States, where universal vaccination of preschool children or adolescents is being contemplated, and where booster doses are being considered.

(JAMA. 1989;262:2567-2571)

Author Affiliations
From the Departments of Medicine (Drs Clarke and Flynn), Urology (Dr Lewis), Pathology (Drs Russell and Miller), and Dermatology (Dr Huntley), University of California, Davis, School of Medicine; and the Departments of Virology, Epidemiology, and Medicine, Baylor College of Medicine, Houston, Tex (Dr Hollinger).

Footnotes
Reprint requests to Department of Internal Medicine, University of California Davis Medical Center, 2221 Stockton Blvd, PCC 4M 3120, Sacramento, CA 95817 (Dr Clarke).

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