Abstract
An inactivated, alum-adjuvanted, whole-virion H5N1 vaccine had been evaluated previously. Hemagglutination inhibition (HI) assays showed that the antibody levels declined significantly, with 4.8%-20.8% and 0%-18.8% of participants retaining seroprotection (HI titer >or=1:40) 6 and 12 months after the second dose, respectively. A third dose of the same vaccine given 12 months after the second dose significantly boosted immune responses. Thirty days after the third dose in the 1.25-, 2.5-, 5-, and 10-microg dose groups, 29.4%, 31.3%, 78.6%, and 90.0% of participants had HI titers >or=1:40, and 52.9%, 81.2%, 92.9%, and 100% of participants had microneutralization titers >or=1:40, respectively. Both the 5-microg and 10-microg doses met European Union criteria.
Trial registration:
ClinicalTrials.gov NCT00660257.
Publication types
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Clinical Trial, Phase I
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adjuvants, Immunologic / administration & dosage
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Adolescent
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Adult
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Antibodies, Viral / blood*
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Double-Blind Method
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Female
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Hemagglutination Inhibition Tests
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Humans
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Immunization
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Immunization, Secondary*
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Influenza A Virus, H5N1 Subtype / immunology*
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Influenza Vaccines / administration & dosage*
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Influenza Vaccines / immunology
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Influenza, Human / immunology*
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Influenza, Human / prevention & control
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Influenza, Human / virology
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Male
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Middle Aged
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Treatment Outcome
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Vaccines, Inactivated / administration & dosage*
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Vaccines, Inactivated / immunology
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Virion / immunology
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Young Adult
Substances
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Adjuvants, Immunologic
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Antibodies, Viral
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Influenza Vaccines
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Vaccines, Inactivated
Associated data
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ClinicalTrials.gov/NCT00660257