From: Subject: JAMA -- Abstract: Vaccination Success Rate and Reaction Profile With Diluted and Undiluted Smallpox Vaccine: A Randomized Controlled Trial, September 8, 2004, Talbot et al. 292 (10): 1205 Date: Wed, 8 Sep 2004 20:35:19 +0300 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C495E3.5B9AE850"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1441 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C495E3.5B9AE850 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://jama.ama-assn.org/cgi/content/short/292/10/1205 JAMA -- Abstract: Vaccination Success Rate and = Reaction Profile With Diluted and Undiluted Smallpox Vaccine: A = Randomized Controlled Trial, September 8, 2004, Talbot et al. 292 (10): = 1205

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Vaccination Success Rate = and Reaction=20 Profile With Diluted and Undiluted Smallpox Vaccine =

A Randomized Controlled Trial =

Thomas R. Talbot, MD, MPH; Jack = T.=20 Stapleton, MD; Rebecca C. Brady, MD;=20 Patricia L. Winokur, MD; David I. = Bernstein,=20 MD; Teresa Germanson, PhD, MPH; = Sandra M.=20 Yoder, MT; Michael T. Rock, PhD; = James E.=20 Crowe, Jr, MD; Kathryn M. Edwards, MD=20

JAMA. 2004;292:1205-1212.

Context  Additional smallpox vaccine = doses are=20 needed to augment current US national stockpile. = Aventis=20 Pasteur smallpox vaccine (APSV), initially = manufactured=20 in the 1950s from the New York Board of Health = vaccinia=20 strain in a frozen preparation, appears as = effective as=20 lyophilized vaccine but the effectiveness of = diluted=20 doses of APSV is unclear.

Objective  To compare the vaccination success = rate=20 and the reaction profile of various APSV = dilutions.=20

Design, Setting, and Participants  A = double-blind,=20 randomized controlled trial of 340 healthy = vaccinia-naive=20 adults aged 18 to 32 years from 3 academic = medical=20 centers who were vaccinated with 1 of 3 strengths = of APSV=20 dilutions (undiluted, 1:5, and 1:10) between = October 9,=20 2002, and February 24, 2003. Volunteers were = followed up=20 every 3 to 5 days until the vaccination site = healed for=20 bandage changes, vaccine response assessment, and = adverse=20 event evaluation, followed by 1- and 2-month clinic=20 evaluations and 6-month telephone interview. =

Main Outcome Measures  Successful = vaccination,=20 defined by presence of a vesicle or pustule at = the=20 inoculation site 6 to 11 days postvaccination, = and local=20 and systemic reactions to vaccination. =

Results  A total of 340 volunteers were = vaccinated=20 (vaccine dose: undiluted, n =3D 113; 1:5 = dilution, n =3D 114;=20 and 1:10 dilution, n =3D 113). Following = vaccination, 99.4%=20 (95% confidence interval [CI], 97.9%-99.9%) of = all=20 volunteers had successful vaccinations. Success = rates did=20 not differ between the dilution groups (undiluted,=20 100.0%; 95% CI, 96.8%-100.0%; 1:5 dilution, 98.2%; 95% = CI,=20 93.8%-99.8%; 1:10 dilution, 100.0% 95% CI, = 96.8%-100.0%;=20 P =3D .33). Overall, 99.7% of volunteers = reported at=20 least 1 local symptom at the vaccination site, = and 61.8%=20 had axillary lymphadenopathy, 15.0% developed = satellite=20 lesions, and 7.6% developed a rash away from the=20 vaccination site. Fever developed in 21.5%. No = differences=20 were noted in local or systemic reactions between the = 3=20 dilution groups (P>.05 for each = comparison). A=20 total of 25% of volunteers missed scheduled = duties due to=20 vaccine-related symptoms.

Conclusions  Even at diluted doses, APSV is = an=20 effective smallpox vaccine, allowing for = expansion of the=20 current stockpile. However, reactogenicity was = not=20 reduced with dilution of the vaccine and, as with = other=20 smallpox vaccines, may impair daily = activities.=20


Author=20 Affiliations: Departments of Medicine (Dr Talbot) and = Pediatrics=20 (Drs Rock, Crowe, and Edwards, and Ms Yoder), Vanderbilt = University=20 School of Medicine, Nashville, Tenn; Department of Medicine, = University of Iowa, Iowa City (Drs Stapleton and Winokur);=20 Department of Pediatrics, Cincinnati Children's Hospital = Medical=20 Center, Cincinnati, Ohio (Drs Brady and Bernstein); and the = EMMES=20 Corporation, Rockville, Md (Dr Germanson).


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