Giuseppe
Emeritus
J Infect Dis. 2008 Sep 22. [Epub ahead of print]
Safety and Immunogenicity of an Inactivated Influenza A/H5N1 Vaccine Given with or without Aluminum Hydroxide to Healthy Adults: Results of a Phase I-II Randomized Clinical Trial.
Keitel WA, Campbell JD, Treanor JJ, Walter EB, Patel SM, He F, Noah DL, Hill H. - 1Baylor College of Medicine, Houston, Texas; 2University of Maryland School of Medicine, Baltimore, and 3The EMMES Corporation, Rockville, Maryland; 4University of Rochester, Rochester, New York; 5Duke University Medical Center, Durham, North Carolina; and 6Southern Research Institute, Birmingham, Alabama.
Background.
Dose-sparing strategies are being explored for vaccines against pandemic influenza. We evaluated the dose-sparing potential of aluminum hydroxide (AlOH) adjuvant.
Methods.
A total of 600 healthy subjects (age, 18-49 years) were randomized to receive 2 vaccinations 1 month apart with subvirion inactivated influenza A/H5N1 vaccine containing 7.5, 15, or 45 mug of hemagglutinin (HA), with or without 600 mug of aluminum hydroxide (AlOH), or 3.75 mug of HA, with or without 300 mug of AlOH. Serum specimens were obtained for antibody assays before and 1 month after each vaccination.
Results.
All formulations were safe. Injection site discomfort was more frequent in groups given vaccines with AlOH. Dose-related increases in antibody responses were noted after both vaccinations ([Formula: see text]): geometric mean titers of hemagglutination inhibition antibody in vaccines with and without AlOH, respectively, were 5.4 and 5.4 for subjects who received 3.75 mug of HA, 7.7 and 5.3 for those who received 7.5 mug of HA, 8.1 and 8.5 for those who received 15 mug of HA, and 14.8 and 12 for those who received 45 mug of HA. A >/=4-fold increase in titer was observed in 2% and 2% of subjects who received 3.75 mug of HA with or without AlOH, respectively; in 14% and 0% who received 7 mug of HA; in 14% and 13% who received 15 mug of HA; and in 33% and 25% who received 45 mug of HA. Addition of AlOH enhanced responses only for subjects who received 7.5 mug of HA, but responses in subjects who received 7.5 mug of HA without AlOH were unexpectedly low.
Conclusion.
Overall, a meaningful beneficial effect of AlOH adjuvant was not observed.
Trial registration. ClinicalTrials.gov identifier: NCT00296634 .
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PMID: 18808338 [PubMed - as supplied by publisher]
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Safety and Immunogenicity of an Inactivated Influenza A/H5N1 Vaccine Given with or without Aluminum Hydroxide to Healthy Adults: Results of a Phase I-II Randomized Clinical Trial.
Keitel WA, Campbell JD, Treanor JJ, Walter EB, Patel SM, He F, Noah DL, Hill H. - 1Baylor College of Medicine, Houston, Texas; 2University of Maryland School of Medicine, Baltimore, and 3The EMMES Corporation, Rockville, Maryland; 4University of Rochester, Rochester, New York; 5Duke University Medical Center, Durham, North Carolina; and 6Southern Research Institute, Birmingham, Alabama.
Background.
Dose-sparing strategies are being explored for vaccines against pandemic influenza. We evaluated the dose-sparing potential of aluminum hydroxide (AlOH) adjuvant.
Methods.
A total of 600 healthy subjects (age, 18-49 years) were randomized to receive 2 vaccinations 1 month apart with subvirion inactivated influenza A/H5N1 vaccine containing 7.5, 15, or 45 mug of hemagglutinin (HA), with or without 600 mug of aluminum hydroxide (AlOH), or 3.75 mug of HA, with or without 300 mug of AlOH. Serum specimens were obtained for antibody assays before and 1 month after each vaccination.
Results.
All formulations were safe. Injection site discomfort was more frequent in groups given vaccines with AlOH. Dose-related increases in antibody responses were noted after both vaccinations ([Formula: see text]): geometric mean titers of hemagglutination inhibition antibody in vaccines with and without AlOH, respectively, were 5.4 and 5.4 for subjects who received 3.75 mug of HA, 7.7 and 5.3 for those who received 7.5 mug of HA, 8.1 and 8.5 for those who received 15 mug of HA, and 14.8 and 12 for those who received 45 mug of HA. A >/=4-fold increase in titer was observed in 2% and 2% of subjects who received 3.75 mug of HA with or without AlOH, respectively; in 14% and 0% who received 7 mug of HA; in 14% and 13% who received 15 mug of HA; and in 33% and 25% who received 45 mug of HA. Addition of AlOH enhanced responses only for subjects who received 7.5 mug of HA, but responses in subjects who received 7.5 mug of HA without AlOH were unexpectedly low.
Conclusion.
Overall, a meaningful beneficial effect of AlOH adjuvant was not observed.
Trial registration. ClinicalTrials.gov identifier: NCT00296634 .
-
PMID: 18808338 [PubMed - as supplied by publisher]
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