| Abstract | BACKGROUND: When the decision was made to prepare for a deliberate release of smallpox, the United States had approximately 15 million doses of Wyeth Dryvax vaccine, which was known to induce significant morbidity when used undiluted; Sanofi Pasteur, Inc., later identified approximately 85 million additional doses in storage. METHODS: Eleven vaccine-dose groups, each with 30 vaccinia-naive subjects, were given diluted Dryvax vaccine or 1 of 2 lots of Sanofi Pasteur smallpox vaccine and were evaluated for vaccination success rates, morbidity, and immune responses. RESULTS: Estimated doses of 10(6.6)-10(8.2) pfu of virus/mL induced major reactions (or "takes") in 93%-100% of subjects in each dose group. No differences in vaccination take rates, lesion size, erythema, and induration or in serum neutralizing-antibody response were detected between the groups. However, systemic reactogenicity and missed activities were significantly lower for the vaccine groups given doses of 10(6.6)-10(7.2) pfu/mL than for those given doses of 10(7.6)-10(8.2) pfu/mL. CONCLUSIONS: These findings support the use of a higher dilution of Wyeth Dryvax vaccine and Sanofi Pasteur smallpox vaccine, given that the resulting morbidity should be significantly lower without loss of vaccine effectiveness. A plan for use of higher dilutions would create an enormous stockpile of vaccine. |
| Authors | Robert B Couch, Patricia Winokur, Kathryn M Edwards, Steven Black, Robert L Atmar, Jack T Stapleton, Jennifer M Kissner, Henry Shinefield, Thomas N Denny, Michael J Bybel, Frances K Newman, Lihan Yan, National Institute of Allergy and Infectious Diseases Smallpox Vaccine Study Group
(Affiliation: Baylor College of Medicine, Houston, TX, 77030, USA.)
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| Journal | The Journal of infectious diseases
(J Infect Dis)
Vol. 195
Issue 6
Pg. 826-32
(Mar 15 2007)
ISSN: 0022-1899 United States |
| PMID | 17299712
(Publication Type: Journal Article, Multicenter Study)
|
| Chemical References |
- Antibodies, Viral
- Smallpox Vaccine
|
| Topics |
- Adolescent
- Adult
- Allantois
(virology)
- Animals
- Antibodies, Viral
(blood)
- Antibody Formation
- Chick Embryo
- Chorion
(virology)
- Dose-Response Relationship, Drug
- Female
- Humans
- Male
- Smallpox Vaccine
(adverse effects, therapeutic use)
- Treatment Outcome
- Variola virus
(isolation & purification, physiology)
|
