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The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.

Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine

Open access
Treanor, John J., Campbell, James D., Zangwill, Kenneth M., Rowe, Thomas, Wolff, Mark·2006·New England Journal of Medicine

Abstract

BACKGROUND: Influenza A (H5N1) viruses could cause a severe worldwide epidemic, with high attack rates, large numbers of deaths and hospitalizations, and wide disruption. Effective vaccines against these viruses in humans are urgently needed. METHODS: We conducted a multicenter, double-blind two-stage study involving 451 healthy adults 18 to 64 years of age who were randomly assigned in a 2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A (H5N1) vaccine of 90, 45, 15, or 7.5 microg of hemagglutinin antigen or placebo. The subjects were followed for the safety analysis for 56 days. Serum samples obtained before each vaccination and again 28 days after the second vaccination were tested for H5 antibody by microneutralization and hemagglutination inhibition. RESULTS: Mild pain at the injection site was the most common adverse event for all doses of vaccine. The frequency of a serum antibody response was highest among subjects receiving doses of 45 microg or 90 microg. Among those who received two doses of 90 microg, neutralization antibody titers reached 1:40 or greater in 54 percent, and hemagglutination-inhibition titers reached 1:40 or greater in 58 percent. Neutralization titers of 1:40 or greater were seen in 43 percent, 22 percent, and 9 percent of the subjects receiving two doses of 45, 15, and 7.5 microg, respectively. No responses were seen in placebo recipients. CONCLUSIONS: A two-dose regimen of 90 mug of subvirion influenza A (H5N1) vaccine does not cause severe side effects and, in the majority of recipients, generates neutralizing antibody responses typically associated with protection against influenza. A conventional subvirion H5 influenza vaccine may be effective in preventing influenza A (H5N1) disease in humans. (ClinicalTrials.gov number, NCT00115986.).

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Metadata

Authors
Treanor, J. J., Campbell, J. D., Zangwill, K. M., Rowe, T., & Wolff, M.
Venue
New England Journal of Medicine
Published
2006-03-30
Volume
354
Issue
13
Pages
1343-1351
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2131170401
Cited by
698
References
16
FWCI
69.94
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine. https://app.cochat.ai/papers/10.1056/nejmoa055778
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Treanor, J. J., Campbell, J. D., Zangwill, K. M., Rowe, T., & Wolff, M. (2006). Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine. New England Journal of Medicine. https://doi.org/10.1056/nejmoa055778

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