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Randomized Controlled Trial
. 2009 Aug 13;27(37):5091-5.
doi: 10.1016/j.vaccine.2009.06.057. Epub 2009 Jul 3.

Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults

Rebecca C Brady  1 , John J Treanor, Robert L Atmar, Wendy A Keitel, Robert Edelman, Wilbur H Chen, Patricia Winokur, Robert Belshe, Irene L Graham, Diana Lee Noah, Kuo Guo, Heather Hill
Affiliations
Randomized Controlled Trial

Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults

Rebecca C Brady et al. Vaccine. .

Abstract

A total of 600 healthy adults > or =65 years were randomized to receive 2 vaccinations 1 month apart of a subvirion avian influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45microg of hemagglutinin (HA) with or without aluminum hydroxide (AlOH). All formulations were safe. Groups given the vaccine with AlOH had more injection site discomfort. Dose-related increases in antibody responses were noted after the second vaccination. Antibody responses to the vaccine were not enhanced by AlOH at any HA dose level. A microneutralization titer > or =40 was observed in 36% and 40% of subjects who received 45microg of HA with or without AlOH, respectively.

Trial registration: ClinicalTrials.gov NCT00294099.

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Figures

Figure 1
Figure 1
Profile of the clinical trial and the reasons for subject withdrawal.
Figure 2
Figure 2
Percentage of subjects with injection site tenderness during the 7 days after receipt of different doses of inactivated influenza A/H5N1 vaccine with (white bars) or without (black bars) aluminum hydroxide (AlOH) adjuvant.
Figure 3
Figure 3
Percentage of subjects achieving a serum HAI or Neut titer ≥ 40 approximately 28 days after receipt of two vaccinations with inactivated influenza A/H5N1 vaccine with (white bars) or without (black bars) aluminum hydroxide (AlOH) adjuvant.
See this image and copyright information in PMC

References

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