sharon sanders
Editor-in-Chief & President
The Journal of Infectious Diseases 2008;197:000?000? 2008 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2008/19704-00XX$15.00
DOI: 10.1086/526537
BRIEF REPORT
Evaluation of the Safety and Immunogenicity of a Booster (Third) Dose of Inactivated Subvirion H5N1 Influenza Vaccine in Humans
Kenneth M. Zangwill,<sup>1</sup>
John J. Treanor,<sup>2</sup>
James D. Campbell,<sup>3</sup>
Diana L. Noah,<sup>5</sup> and
Jennifer Ryea<sup>4</sup>
<sup>1</sup>University of California, Los Angeles (UCLA), Center for Vaccine Research, Los Angeles Biomedical Research Institute at Harbor‐UCLA Medical Center, Los Angeles; <sup>2</sup>University of Rochester, Rochester, New York; <sup>3</sup>University of Maryland School of Medicine Center for Vaccine Development, Baltimore, and <sup>4</sup>Emmes Corporation, Rockville, Maryland; <sup>5</sup>Southern Research Institute, Birmingham, Alabama
Received 21 June 2007; accepted 7 August 2007; electronically published 29 January 2008.
Previously, we evaluated 2 doses of H5N1 influenza vaccine in persons 18?64 years of age (placebo and 7.5‐, 15‐, 45‐, or 90‐μg doses), separated by 28 days. In this study, 337 participants received a third dose, 6 months thereafter. Microneutralization (MN) and hemagglutination‐inhibition geometric mean titers (GMTs) of antibody declined before the third dose. Twenty‐eight days after the third dose, 78%, 67%, 43%, and 31% of recipients in the 90‐, 45‐, 15‐, and 7.5‐μg‐dose groups had a MN GMT
1:40, respectively. Five months later, MN GMTs were significantly greater than those after the second dose. (Trial registration: Clinical Trials.gov identifier NCT00240968.)
http://www.journals.uchicago.edu/doi/abs/10.1086/526537
0022-1899/2008/19704-00XX$15.00
DOI: 10.1086/526537
BRIEF REPORT
Evaluation of the Safety and Immunogenicity of a Booster (Third) Dose of Inactivated Subvirion H5N1 Influenza Vaccine in Humans
Kenneth M. Zangwill,<sup>1</sup>
John J. Treanor,<sup>2</sup>
James D. Campbell,<sup>3</sup>
Diana L. Noah,<sup>5</sup> and
Jennifer Ryea<sup>4</sup>
<sup>1</sup>University of California, Los Angeles (UCLA), Center for Vaccine Research, Los Angeles Biomedical Research Institute at Harbor‐UCLA Medical Center, Los Angeles; <sup>2</sup>University of Rochester, Rochester, New York; <sup>3</sup>University of Maryland School of Medicine Center for Vaccine Development, Baltimore, and <sup>4</sup>Emmes Corporation, Rockville, Maryland; <sup>5</sup>Southern Research Institute, Birmingham, Alabama
Received 21 June 2007; accepted 7 August 2007; electronically published 29 January 2008.
- Potential conflicts of interest: none reported.
Presented in part: Options for the Control of Influenza VI, Toronto, 17?23 June 2007.
Financial support: National Institute of Allergy and Infectious Diseases, National Institutes of Health (contracts N01 AI 25460, AI 25461, AI 25463, and AI 30068 ); federal General Clinical Research Center (grants M01 RR00044, M01 RR165001, and M01‐RR00425).
Previously, we evaluated 2 doses of H5N1 influenza vaccine in persons 18?64 years of age (placebo and 7.5‐, 15‐, 45‐, or 90‐μg doses), separated by 28 days. In this study, 337 participants received a third dose, 6 months thereafter. Microneutralization (MN) and hemagglutination‐inhibition geometric mean titers (GMTs) of antibody declined before the third dose. Twenty‐eight days after the third dose, 78%, 67%, 43%, and 31% of recipients in the 90‐, 45‐, 15‐, and 7.5‐μg‐dose groups had a MN GMT
http://www.journals.uchicago.edu/doi/abs/10.1086/526537