Abstract
BackgroundInfluenza vaccine immunogenicity is diminished in patients living with HIV/AIDS. We evaluated the cost-effectiveness and expected value of perfect information (EVPI) of three alternative influenza vaccine dosing strategies intended to increase immunogenicity in those patients.MethodsA randomized, multi-centered, controlled, vaccine trial was conducted at 12 CIHR Canadian HIV Trials Network sites. Three dosing strategies with seasonal, inactivated trivalent, non-adjuvanted intramuscular vaccine were used in HIV infected adults: two standard doses over 28 days (Strategy A), two double doses over 28 days (Strategy B) and a single standard dose of influenza vaccine (Strategy C), administered prior to the 2008 influenza season. The comparator in our analysis was practice in the previous year, in which 82.8% of HIV/AIDS received standard-dose vaccination (Strategy D). A Markov cohort model was developed to estimate the monthly probability of Influenza-like Illness (ILI) over one influenza season. Costs and quality-adjusted life years, extrapolated to the lifetime of the hypothetical study cohorts, were estimated in calculating incremental cost-effectiveness ratios (ICER) and EVPI in conducting further research.Results298 patients with median CD4 of 470 cells/µl and 76% with viral load suppression were randomized. Strategy C was the most cost-effective strategy for the overall trial population and for suppressed and unsuppressed individuals. Mean ICERs for Strategy A for unsuppressed patients could also be considered cost-effective. The level of uncertainty regarding the decision to implement strategy A versus C for unsuppressed individuals was high. The maximum acceptable cost of reducing decision uncertainty in implementing strategy A for individuals with unsuppressed pVL was $418,000 - below the cost of conducting a larger-scale trial.ConclusionOur results do not support a policy to implement increased antigen dose or booster dosing strategies with seasonal, inactivated trivalent, non-adjuvanted intramuscular vaccine for individuals with HIV in Canada.Trial RegistrationClinicalTrials.gov NCT00764998.
Highlights
The likelihood of being clinically protected after influenza vaccination is diminished in those living with HIV/AIDS [1]
Current guidelines recommend that individuals with HIV/ AIDS receive the same standard influenza vaccination dosing strategy as the general population
A recent randomized trial conducted in Canada during the 2008 influenza season found that even with increased antigen dose and booster dosing, non-adjuvanted influenza vaccine immunogenicity is poor in HIV-infected individuals [9]
Summary
The likelihood of being clinically protected after influenza vaccination is diminished in those living with HIV/AIDS [1]. November) [2,4] This is supported by several studies and metaanalyses suggesting reduced risk of influenza cases [5,6,7]. A recent randomized trial conducted in Canada during the 2008 influenza season found that even with increased antigen dose and booster dosing, non-adjuvanted influenza vaccine immunogenicity is poor in HIV-infected individuals [9]. There was a great deal of uncertainty regarding the level of clinical protection between dosing strategies, and within different patient strata. Influenza vaccine immunogenicity is diminished in patients living with HIV/AIDS. We evaluated the costeffectiveness and expected value of perfect information (EVPI) of three alternative influenza vaccine dosing strategies intended to increase immunogenicity in those patients
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