A Pragmatic Trial to Quantitatively and Qualitatively Assess Different Techniques for the ID Administration of Fractional Dose IPV in a Campaign Setting in The Gambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,721
- 试验地点
- 1
- 主要终点
- Total time taken to deliver ID fIPV using each of the three methods of administration
研究概览
简要总结
The introduction of one dose of the inactivated poliovirus vaccine (IPV) into routine immunization schedules in OPV-only using countries as part of the Global Polio Eradication Initiative (GPEI) was planned for completion in 2016. However, due to recent developments in the global IPV supply landscape, the GPEI polio eradication program is facing a critical shortage of the vaccine which is forecast to continue until at least the end of 2017. The shortage means that some countries that have already introduced the vaccine, but which are considered to be relatively low risk (The Gambia included), will be left without adequate supplies and in other countries IPV introduction is being unavoidably delayed.
Exacerbating the shortage is the need to reserve IPV for future outbreak responses (OBR). The current OBR protocol recommends that, if a circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak occurs (after the recent global switch from trivalent to bivalent OPV), a large scale IPV campaign will be implemented to increase population immunity to the type 2 poliovirus in an large area surrounding the outbreak as high risk of extending transmission.
Due to above, dose-sparing through the administration of intra-dermal (ID) fractional (one fifth - 0.1mL) doses of IPV (fIPV) has become a very important focus and, for planning purposes, there is an urgent need to assess the practical and logistic challenges a country such as The Gambia would face in rapidly undertaking an ID fIPV campaign.
详细描述
Background information and rationale
Background information
Polio eradication requires the removal of all polioviruses from the human population, whether wild-type poliovirus (WPV) or those vaccine-derived polioviruses (VDPV) emanating from the oral poliovirus vaccine (OPV). The Polio Eradication & Endgame Strategic Plan 2013-2018 provides a framework for interruption of WPV transmission in remaining endemic foci and lays out plan for the new polio endgame. This will include the withdrawal of Sabin strains, starting with the type 2 strain, and the introduction of the inactivated poliovirus vaccine (IPV), for risk mitigation purposes.
The introduction of one dose of IPV into routine immunization schedules in OPV-only using countries was planned for completion in 2016. However, due to recent developments in the global IPV supply landscape, the polio eradication program is facing a critical shortage of the vaccine which is currently forecast to continue until at least the end of 2017. The shortage is not only preventing the universal introduction of one dose of IPV into some routine immunization schedule but may also mean that some countries who have already introduced the vaccine, but are considered to be relatively low risk, will be left without adequate supplies.
Exacerbating the shortage is the demand to reserve IPV for future outbreak responses (OBR). The current OBR protocol recommends that, in the event of a circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak after the switch, a large scale IPV response is implemented - a preventive campaign in the zone surrounding the outbreak (rather than the core area of the outbreak itself) to increase population immunity to the type 2 poliovirus in an area at high risk of driving further transmission considering the ongoing VDPV2 outbreak nearby.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
six vaccination teams will be randomly assigned to administer the three different ID fIPV administration technique the campaign days
入排标准
- 年龄范围
- 4 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written or thumb-printed informed consent obtained from a child's parent or guardian
- •Resident within the geographical area which is expected to be covered by the campaign
- •Between 4 and 59 months of age at the time of the campaign
排除标准
- •Anaphylaxis or a severe, potentially life threatening, allergic reaction to a previous vaccination
- •Any other condition or significant acute illness meaning that it is judged to be against the infant's or child's best interests to receive ID fIPV (note that most chronic illnesses and minor acute illnesses - when normal vaccinations would be encouraged, do not represent exclusions for the trial)
研究组 & 干预措施
ID Needle and Syringe
Fractional (0.1mL) dose of inactivated poliovirus vaccine (IPV) administered using a needle and syringe
干预措施: Needle and syringe (Device)
ID Adaptor (Helm)
Fractional (0.1mL) dose of inactivated poliovirus vaccine (IPV) administered using a needle and syringe with an ID adaptor
干预措施: ID adaptor (Device)
ID Jet Injector (Tropis, Pharmajet)
Fractional (0.1mL) dose of inactivated poliovirus vaccine (IPV) administered by needle and syringe with a disposable syringe jet injecto
干预措施: ID Jet Injector (Tropis, Pharmajet) (Device)
结局指标
主要结局
Total time taken to deliver ID fIPV using each of the three methods of administration
时间窗: Collected on day 1, 2 or 3 of the vaccination campaign
Qualitative measures of administration method utility
时间窗: Collected on day 1, 2 or 3 of the vaccination campaign
Ergonomic characteristics of the intradermal administration methods collected through questionnaires
Local and systemic reactogenicity collected according to standard severity score (0 - 4) system.
时间窗: Day 3 following vaccination
Local reactogenicity (induration, erythema, tenderness, fever, vomiting, diarrhoea, feeding, irritability) will be collected on all vaccines on day 3 following vaccine administration
Serious adverse events (SAE) and adverse events (AE) following ID fIPV administration
时间窗: Within 4 weeks of vaccination
Semi-quantitative measure of distress in infants and children associated with ID fIPV administration
时间窗: Collected on day 1, 2 or 3 of the vaccination campaign
Infant distress will be graded according to a visual analogue scale
Storage volumes of equipment required for ID fIPV delivery and subsequent bio-waste disposal including any differences the equipment required to safely deliver such vaccinations in a campaign
时间窗: Collected on day 1, 2 or 3 of the vaccination campaign
The volume of the disposables and biowaste created by each of the administration methods will be recorded.
Number of ID fIPV doses deliverable per IPV vial using each of the three administration methods (to identify any wastage associated with syringe/device filling)
时间窗: Collected on day 1, 2 or 3 of the vaccination campaign
Immune response to ID fIPV (poliovirus neutralization assays)
时间窗: Serum sample taken at baseline (pre-vaccination) and 4 weeks following vaccination
Poliovirus neutralization assays
Changes in the time taken to deliver the ID fIPV and in the immune responses generated over the course of a 3 day campaign
时间窗: Over 3 days of the campaign
Changes in the vaccine vial monitors (VVM) and also temperature deviations identified using a continuous temperature data logger associated with a campaign using each of the three administration methods
时间窗: Over 3 days of the campaign
Qualitative factors which might influence campaign uptake in The Gambia and comparable sub-Saharan African settings
时间窗: 1 week following vaccination campaign
Number of ID fIPV doses delivered using each of the three methods in the course of a defined campaign day by one vaccination team
时间窗: Collected on day 1, 2 or 3 of the vaccination campaign
次要结局
未报告次要终点