Abstract | CONTEXT: The attenuated, tissue-cultured, third-generation smallpox vaccine LC16m8 was administered to vaccinia-naive infants in Japan during the 1970s without serious adverse events. It is a good candidate for use as part of a prevention plan for bioterrorism. OBJECTIVE: To assess the immunogenicity and frequency of adverse events of LC16m8 vaccine in unvaccinated and previously vaccinated adults. DESIGN, SETTING, AND PARTICIPANTS: Between 2002 and 2005 we vaccinated and revaccinated 1529 and 1692 adults, respectively, in the Japan Self-Defense Forces with LC16m8 vaccine, given intraepidermally using a bifurcated needle. Vaccinees were examined 10 to 14 days after vaccination to determine if they had developed a major skin reaction ("take"). Neutralizing antibody responses among 200 participants were assessed using a plaque-reduction neutralization test 30 days postvaccination. We monitored vaccinees for adverse events for 30 days postvaccination. MAIN OUTCOME MEASURES: RESULTS: The proportions of take in vaccinia-naive and previously vaccinated individuals were 1443 of 1529 (94.4% [95% confidence interval {CI}, 93.2%-95.9%] and 1465 of 1692 (86.6% [95% CI, 85.0%-88.2%]), respectively. Seroconversion or an effective booster response among the individuals with take was elicited in 37 of 41 (90.2% [95% CI, 81.2%-99.3%]) vaccinia-naive participants and in 93 of 155 (60.0% [95% CI, 52.3%-67.7%]) previously vaccinated participants. One case of allergic dermatitis and another of erythema multiforme, both of which were mild and self-limited, were suspected to be caused by vaccination. No severe adverse events were observed. CONCLUSION: Administration of an attenuated tissue-cultured smallpox vaccine (LC16m8) to healthy adults was associated with high levels of vaccine take and seroconversion in those who were vaccinia-naive and yielded an effective booster response in some previously vaccinated individuals.
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Authors | Tomoya Saito, Tatsuya Fujii, Yasuhiro Kanatani, Masayuki Saijo, Shigeru Morikawa, Hiroyuki Yokote, Tsutomu Takeuchi, Noriyuki Kuwabara |
Journal | JAMA
(JAMA)
Vol. 301
Issue 10
Pg. 1025-33
(Mar 11 2009)
ISSN: 1538-3598 [Electronic] United States |
PMID | 19278946
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Viral
- Smallpox Vaccine
- Vaccines, Attenuated
- smallpox vaccine LC16m8
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Topics |
- Adolescent
- Adult
- Antibodies, Viral
(biosynthesis, blood)
- Humans
- Immunity, Active
- Immunization Programs
- Immunization, Secondary
- Japan
- Middle Aged
- Military Personnel
- Neutralization Tests
- Smallpox Vaccine
(adverse effects, immunology)
- Vaccination
(adverse effects)
- Vaccines, Attenuated
(adverse effects, immunology)
- Vaccinia virus
(immunology)
- Young Adult
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