Vaccine
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The main potential areas of bias in economic evaluation (EE) in health care can be categorised as follows: (1) choosing the study question and design, (2) estimating clinical effectiveness; (3) choosing cost data sources, and (4) reporting and dissemination of results. Each of these is discussed while focusing on vaccines. ⋯ This paper explores the differences between them in relation to the four areas of bias. Finally, remedies to avoid bias in research and publications are proposed and discussed.
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Randomized Controlled Trial Clinical Trial
Safety and immunogenicity of CPG 7909 injection as an adjuvant to Fluarix influenza vaccine.
CPG 7909, a 24-mer B-Class CpG oligodeoxynucleotide (ODN), was tested for safety, tolerability and its ability to augment the immunogenicity of a commercial trivalent killed split influenza vaccine (Fluarix containing A/Beijing/262/95, A/Sydney/5/97 and B/Harbin/7/94; SmithKline Beecham) in a phase Ib blinded, randomized, controlled clinical trial. Sixty healthy volunteers were recruited in two consecutive cohorts of 30 subjects, who were randomly assigned to receive Fluarix plus 1mg CPG 7909 or Fluarix plus saline control (15 subjects each). Vaccines were administered by intramuscular injection on a single occasion with subjects in the first cohort receiving a 1/10th dose of Fluarix and those in the second cohort receiving the full-dose. ⋯ Humoral responses were not significantly enhanced by the addition of CPG 7909, except in individuals with pre-existing immunity to A/Sydney/5/97 strain (baseline HI activity titre >20), where there was a trend to higher HI activity with CPG 7909 (P = 0.06). The addition of CPG 7909 to the 1/10th dose of Fluarix did however result in significantly higher levels of IFN-gamma secretion from peripheral blood mononuclear cells recovered at 4 weeks and restimulated ex vivo with A/Beijing/262/95 (P = 0.048) and B/Harbin/7/94 (P = 0.0057), restoring these to the level seen with full-dose vaccine. These results suggest that addition of CPG 7909 to Fluarix may allow the use of reduced vaccine doses without reduced immunogenicity.
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Control measures to limit the spread of a cholera outbreak in Pohnpei Island (Micronesia), included mass vaccination with the single-dose live-attenuated oral cholera vaccine CVD 103-HgR as a potential adjunct measure. The outbreak provided a unique opportunity to evaluate the practicality of use and effectiveness of this vaccine. Under field conditions encountered in Pohnpei, crude vaccine efficacy was estimated at 79.2% (95% CI: 71.9-84.6%) in the target population. Retrospective analysis suggests that mass vaccination with oral cholera vaccines can be a useful adjunct tool for controlling outbreaks, particularly if implemented early in association with other standard control measures.
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In 1998, Australia enacted comprehensive national legislation making receipt of the maternity immunisation allowance (MIA) and the child care benefit (CCB) conditional on evidence of age-appropriate immunisation. We assessed the impact of this policy on immunisation status using a nationally representative population-based case-control study of 589 fully immunised controls and 190 incompletely immunised cases, aged 28-31 months. ⋯ The use of legislated financial immunisation incentives for parents appears to be widely accepted among Australian parents and to have had an impact on immunisation uptake. The policy may serve as a model for other comparable countries.