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Sharon E. Frey, MD; Frances K. Newman, MS; Lihan Yan, MS; Robert B. Belshe, MD

JAMA. 2003;289:3295-3299.

Context  There is renewed interest in use of smallpox vaccine due to the potential for a bioterrorist attack. This would involve vaccinating health care workers who were previously vaccinated.

Objective  To evaluate the use of diluted vaccinia virus in vaccination of previously vaccinated (non-naive) participants.

Design, Setting, and Participants  Eighty non-naive participants, aged 32 to 60 years, were randomized in a single-blinded study to receive either undiluted or diluted (1:3.2, 1:10, or 1:32) doses of smallpox vaccine. A comparison group, aged 18 to 31 years, of 10 vaccinia-naive participants received undiluted vaccine. Participants were enrolled between April 1 and May 15, 2002, at the National Institute of Allergy and Infectious Diseases Vaccine and Treatment Evaluation Unit at Saint Louis University, St Louis, Mo.

Intervention  Smallpox vaccine was administered by scarification using 15 skin punctures in the deltoid region of the arm.

Main Outcome Measures  Presence of a major reaction, defined as a vesicular or pustular lesion or area of palpable induration surrounding a central lesion following vaccination, and measures of viral shedding and antibody titers.

Results  Initial vaccination resulted in a major reaction in 64 of 80 non-naive participants. Ninety-five percent of non-naive participants had major reactions in the undiluted group, 90% in the 1:3.2 dilution group, 81% in the 1:10 dilution group, and 52.6% in the 1:32 dilution group. All (n = 10) of the vaccinia-naive participants had major reactions. Compared with vaccinia-naive participants, non-naive participants had significantly smaller skin lesions (P = .04) and significantly less incidence of fever (P = .02). Preexisting antibody was present in 76 of 80 non-naive participants. Antibody responses were significantly higher and occurred more rapidly in the non-naive participants compared with the vaccinia-naive participants (P = .002 for day 28 and P = .003 for 6 months). Vaccinia-naive participants shed virus from the vaccination site 2 to 6 days longer and had significantly higher peak mean viral titers when compared with the non-naive participants (P = .002).

Conclusions  Previously vaccinated persons can be successfully revaccinated with diluted (≤1:10) smallpox vaccine. Fewer adverse reactions were observed in this study of non-naive participants when compared with events in vaccinia-naive participants, which may be due to immunologic memory.

Author Affiliations: Department of Medicine, Saint Louis University School of Medicine and National Institute of Allergy and Infectious Diseases Vaccine and Treatment Evaluation Unit, St Louis, Mo (Drs Frey and Belshe and Ms Newman) and EMMES Corporation, Rockville, Md (Ms Yan).

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