Effect of aluminum hydroxide adjuvant on the immunogenicity of the 2009 pandemic influenza A/H1N1 vaccine: multi-level modeling of data with repeated measures / 生物医学与环境科学(英文)
Biomedical and Environmental Sciences
;
(12): 624-629, 2011.
Article
in English
| WPRIM
| ID: wpr-235589
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the effect of the aluminum hydroxide (Al-OH) adjuvant on the 2009 pandemic influenza A/H1N1 (pH1N1) vaccine.</p><p><b>METHODS</b>In a multicenter, double-blind, randomized, placebo-controlled trial, participants received two doses of split-virion formulation containing 15 μg hemagglutinin antigen, with or without aluminum hydroxide (Al-OH). We classified the participants into six age categories (>61 years, 41-60 years, 19-40 years, 13-18 years, 8-12 years, and 3-7 years) and obtained four blood samples from each participant on days 0, 21, 35, and 42 following the first dose of immunization. We assessed vaccine immunogenicity by measuring the geometric mean titer (GMT) of hemagglutination inhibiting antibody. We used a two-level model to evaluate the fixed effect of aluminum Al-OH and other factors, accounting for repeated measures.</p><p><b>RESULTS</b>The predictions of repeated measurement on GMTs of formulations with or without Al-OH, were 80.35 and 112.72, respectively. Al-OH significantly reduced immunogenicity after controlling for time post immunization, age-group and gender.</p><p><b>CONCLUSION</b>The Al-OH adjuvant does not increase but actually reduces the immunogenicity of the split-virion pH1N1 vaccine.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Virology
/
Blood
/
Hemagglutination Inhibition Tests
/
Influenza Vaccines
/
Chemistry
/
China
/
Double-Blind Method
/
Adjuvants, Pharmaceutic
/
Epidemiology
/
Data Interpretation, Statistical
Type of study:
Controlled clinical trial
/
Prognostic study
/
Risk factors
Limits:
Adolescent
/
Adult
/
Child
/
Child, preschool
/
Female
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
English
Journal:
Biomedical and Environmental Sciences
Year:
2011
Type:
Article
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