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Previous Volume 346:1265-1274 April 25, 2002 Number 17 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Fauci, A. S. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background To evaluate the potential to increase the supply of smallpox vaccine (vaccinia virus), we compared the response to vaccination with 10^8.1, 10^7.2, and 10^7.0 plaque-forming units (pfu) of vaccinia virus per milliliter.

Methods In this randomized, single-blind, prospective study, 680 adults who had not been previously immunized were inoculated intradermally with undiluted vaccine (mean titer, 10^8.1 pfu per milliliter), a 1:5 dilution, or a 1:10 dilution of vaccinia virus with use of a bifurcated needle, and the site was covered with a semipermeable dressing. Subjects were monitored for vesicle formation (an indicator of the success of vaccination) and adverse events for 56 days after immunization.

Results Success rates did not differ significantly among the groups and ranged from 97.1 to 99.1 percent after the first vaccination. Both the undiluted and diluted vaccines were reactogenic. In addition to the formation of pustules, common adverse events included the formation of satellite lesions, regional lymphadenopathy, fever, headache, nausea, muscle aches, fatigue, and chills consistent with the presence of an acute viral illness. Generalized and localized rashes, including two cases of erythema multiforme, were also observed.

Conclusions When given by a bifurcated needle, vaccinia virus vaccine can be diluted to a titer as low as 10^7.0 pfu per milliliter (approximately 10,000 pfu per dose) and induce local viral replication and vesicle formation in more than 97 percent of persons.

Source Information

From the Department of Medicine, National Institute of Allergy and Infectious Diseases Vaccine and Treatment Evaluation Unit, Saint Louis University School of Medicine, St. Louis (S.E.F., F.K.N., R.B.B.); the Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston (R.B.C., R.L.A.); the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore (C.O.T., R.E.); the University of Rochester School of Medicine and Dentistry, Rochester, N.Y. (J.J.T., C.M.N.); and the Emmes Corporation, Rockville, Md. (M.W.).

This article was published at www.nejm.org on March 28, 2002.

Address reprint requests to Dr. Belshe at the Division of Infectious Diseases and Immunology, Saint Louis University Health Sciences Center, 3635 Vista Ave. (FDT-8N), St. Louis, MO 63110.

Full Text of this Article

Related Letters:

Responses to Smallpox Vaccine
Sauri M. A., Frelinger J. A., Garba M. L., Belshe R. B., Frey S. E.
Extract | Full Text | PDF  
N Engl J Med 2002; 347:689-690, Aug 29, 2002. Correspondence

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