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临床试验/NCT05996549
NCT05996549招募中4 期

Acceptability, Cost-Effectiveness, and Capacity of a Facility-Based Seasonal Influenza Vaccination: A Study in Selected Hospitals of Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 2,567 人开始时间: 2022年9月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
2,567
试验地点
1
主要终点
influenza vaccine acceptability

研究概览

简要总结

Background: In Bangladesh, seasonal influenza imposes considerable health and economic burden, particularly for those at high risk of severe disease. To prevent influenza and lessen the economic burden, despite the World Health Organization's (WHO) recommendation of seasonal influenza vaccination prioritizing high-risk groups, many low-income countries, including Bangladesh, lack a national policy/programme and relevant statistics on seasonal influenza vaccination.

Objectives:

  1. To determine influenza vaccine acceptability, health beliefs, barriers, and intention of receiving influenza vaccine among targeted high-risk populations
  2. To determine the cost-effectiveness of a seasonal influenza vaccination targeting high-risk populations during visits to health facilities for routine care
  3. To investigate the required capacity for a potential seasonal influenza vaccination programme targeting high-risk populations during their visits to health facilities for routine care

Methods: The study will be conducted in three hospitals' inpatient and outpatient departments with ongoing hospital-based influenza surveillance (HBIS). To meet objective 1, the investigators will collect quantitative data on participants' acceptability, health beliefs, barriers, and vaccination intentions using the health belief model (HBM) from patients meeting criteria for high-risk populations attending two public tertiary-level hospitals. To meet objective 2, in one of the two hospitals, the investigators will run an influenza vaccination campaign before the influenza season (the vaccines will be in the southern hemisphere), where the vaccine will be offered free of cost to high-risk patients, and in the second hospital, vaccination will not be offered. Both the vaccinated and unvaccinated participants will then be followed-up for one year period once a month to record any influenza-like illness, hospitalization, and death. Additional data for objective two on direct and indirect costs associated with influenza illness will be collected from patients with influenza-like illness (ILI) and severe acute respiratory infections (SARI) at one public and one private hospital. To meet objective 3, the investigators will estimate the required number of influenza vaccines, safe injections, and total storage volume utilizing secondary data. The investigators will use a deterministic Markov decision-analytic model to estimate the cost-effectiveness of facility-based vaccination in Bangladesh.

详细描述

Background: Globally, seasonal influenza is a leading cause of morbidity and mortality with significant health and economic consequences. According to the World Health Organization (WHO), influenza affects around one billion people each year, with 3 to 5 million suffering from severe illness, leading to 290,000 to 650,000 deaths each year . The burden of influenza illness is significantly higher in low- and middle-income countries (LMICs) than in high-income countries (HIC) . Pregnant women, children under five years, and adults with co-morbid conditions in LMICs are more likely to get severe influenza illness. In a systematic review and meta-analysis of 27 studies found that elderly people were at higher risk of death and hospital admission during flu season. That study also found that pregnant women and children were at higher risk of developing pneumonia and requiring hospital admission; the adults with co-morbidity conditions were at risk of hospitalization and intensive care admission during flu seasons.

In order to prevent influenza infection and lessen the severity of the illness, in 2012, the WHO advised an annual influenza vaccine dosage for persons at high risk of acquiring a severe influenza illness. Despite the WHO recommendation of seasonal influenza vaccination prioritizing high-risk groups, 76% of the low-income countries, including Bangladesh, lack a national policy/programme on seasonal influenza targeting high-risk groups. Also, the lack of context-specific knowledge on the economic burden of influenza vaccines on high-risk groups, lack of medical, socio-behavioral patterns, and socio-economic consequences of influenza have been identified as challenges for promoting influenza vaccinations in LMICs.

In Bangladesh, around 25 million people of all ages sought outpatient treatment for influenza, where the yearly direct cost of influenza-associated outpatient visits was US$ 108 million. Moreover, approximately 30,592 laboratory-confirmed influenza patients of all ages were hospitalized each year, with an estimated annual influenza-associated hospitalization cost of US$ 1.4 million. Influenza vaccines are the most reliable method for preventing influenza infection. But unfortunately, Bangladesh does not have a national influenza vaccination program among the WHO-recommended high-risk population. The Ministry of Health and Family Welfare (MoH&FW), Government of the People's Republic of Bangladesh, only offers influenza vaccination to all Hajj pilgrims free of cost as part of the mandatory requirement for all Hajj pilgrims by the Saudi Government. However, there is a lack of information to drive the MoH&FW policy on influenza vaccinations in high-risk populations.

For reducing the influenza disease burden, particularly among high-risk populations, influenza vaccination has been proven to be the most effective and cost-effective approach. Immune responses elicited by influenza vaccines are generally strain-specific. Antibody against one influenza virus type or subtype generally confers limited or no protection against another type or subtype, nor does it typically confer protection against antigenic variants of the same virus that arise by antigenic drift. However, among adults, vaccination can cause a "back boost" of antibody titers against influenza A viruses that have been encountered previously either by vaccination or natural infection. Due to antigenic drift and shift, influenza vaccines are taken annually with an efficacy between 40-60% varies widely by setting and by influenza seasons. In addition, a systematic review of 118 studies on the cost-effectiveness of influenza vaccination revealed that 22 of the 118 studies showed influenza vaccination to be cost-saving. The study reported cost-effectiveness ratios of $10,000/outcome in 13 studies, $10,000 to $50,000 in 13 studies, and ≥$50,000 in 3 studies. Despite the fact that influenza vaccination was cost-effective, the cost-effectiveness parameters may not be applicable for all countries' contexts because of the differences in influenza disease profile, influenza vaccination unit costs, and health system delivery mechanisms. Hence, country-specific estimates are essential for the optimal allocation of scarce resources.

The investigators extensively searched influenza vaccination cost-effectiveness studies targeting high-risk populations in Bangladesh. But to date, there is scarce evidence in Bangladesh to inform policymakers about the acceptability, cost-effectiveness, and required capacity of influenza vaccination among the WHO-defined high-risk group population. Therefore, the investigators propose to generate preliminary data on high-risk groups' health beliefs, barriers, and intent to receive the influenza vaccine. The investigators will also generate preliminary data on the acceptability, cost-effectiveness, and required capacity for a facility-based influenza vaccination program to support policy decisions on influenza vaccination in Bangladesh among the high-risk population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Influenza vaccination arm

Experimental

In the Influenza vaccination hospital, the investigators have run an influenza vaccination campaign before the influenza season, where the vaccines are free to high-risk patients. Posters and leaflets containing information on influenza vaccination have been displayed at the vaccination booths and key hospital locations with information on the vaccination. Eligible patients from inpatients and outpatients of all departments have been offered to take the vaccine during the vaccination campaign. Nurses/ Health Assistants (HA) have provided vaccines after receiving written consent. Vaccination cards have been issued to the participants. All enrolled vaccine recipients are informed about notifying of possible adverse events after immunization (AEFI). To report any AEFI, the investigators are following the existing surveillance channel established by the WHO and the Ministry of Health and Family Welfare(MoHFW), the government of Bangladesh.

干预措施: Quadrivalent Influenza Vaccine (Drug)

结局指标

主要结局

influenza vaccine acceptability

时间窗: one year

proportion of high-risk group people reported about intention to receive influenza vaccine

incremental cost-effectiveness ratios (ICERs)

时间窗: one year

amount per DALYs gained or saved

次要结局

  • required capacity related to self-injection equipment(one year)
  • perceived susceptibility and severity(one year)
  • perceived barriers and benefits(one year)
  • required storage capacity(one year)
  • required capacity related to vaccine doses(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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