PDF(Pubmed)
Abstract：
BACKGROUND: New strategies to increase measles and rubella vaccine coverage, particularly in low- and middle-income countries, are needed if elimination goals are to be achieved. With this regard, measles and rubella vaccine microneedle patches (MRV-MNP), in which the vaccine is embedded in dissolving microneedles, offer several potential advantages over subcutaneous delivery. These include ease of administration, increased thermostability, an absence of sharps waste, reduced overall costs and pain-free administration. This trial will provide the first clinical trial data on MRV-MNP use and the first clinical vaccine trial of MNP technology in children and infants.
METHODS: This is a phase 1/2, randomized, active-controlled, double-blind, double-dummy, age de-escalation trial. Based on the defined eligibility criteria for the trial, including screening laboratory investigations, 45 adults [18-40 years] followed by 120 toddlers [15-18 months] and 120 infants [9-10 months] will be enrolled in series. To allow double-blinding, participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) subcutaneous (SC) injection or a placebo MNP and the MRV by SC injection (MRV-SC). Local and systemic adverse event data will be collected for 14 days following study product administration. Safety laboratories will be repeated on day 7 and, in the adult cohort alone, on day 14. Unsolicited adverse events including serious adverse events will be collected until the final study visit for each participant on day 180. Measles and rubella serum neutralizing antibodies will be measured at baseline, on day 42 and on day 180. Cohort progression will be dependent on review of the unblinded safety data by an independent data monitoring committee.
CONCLUSIONS: This trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination.
BACKGROUND: Pan-African Clinical Trials Registry 202008836432905 .
RESULTS: gov NCT04394689.
METHODS: This is a phase 1/2, randomized, active-controlled, double-blind, double-dummy, age de-escalation trial. Based on the defined eligibility criteria for the trial, including screening laboratory investigations, 45 adults [18-40 years] followed by 120 toddlers [15-18 months] and 120 infants [9-10 months] will be enrolled in series. To allow double-blinding, participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) subcutaneous (SC) injection or a placebo MNP and the MRV by SC injection (MRV-SC). Local and systemic adverse event data will be collected for 14 days following study product administration. Safety laboratories will be repeated on day 7 and, in the adult cohort alone, on day 14. Unsolicited adverse events including serious adverse events will be collected until the final study visit for each participant on day 180. Measles and rubella serum neutralizing antibodies will be measured at baseline, on day 42 and on day 180. Cohort progression will be dependent on review of the unblinded safety data by an independent data monitoring committee.
CONCLUSIONS: This trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination.
BACKGROUND: Pan-African Clinical Trials Registry 202008836432905 .
RESULTS: gov NCT04394689.
摘要：
背景：增加麻疹和风疹疫苗覆盖率的新策略，特别是在低收入和中等收入国家，如果要实现消除目标，就需要。在这方面,麻疹和风疹疫苗微针贴片（MRV-MNP），其中疫苗嵌入溶解微针中，提供了几个潜在的优势比皮下输送。这些包括易于管理，增加热稳定性，没有尖锐的废物，降低总成本和无痛管理。该试验将提供有关MRV-MNP使用的第一个临床试验数据，以及MNP技术在儿童和婴儿中的第一个临床疫苗试验。
方法：这是1/2阶段，随机，主动控制，双盲,双假人,年龄降级试验。根据确定的审判资格标准，包括筛查实验室调查，45名成人[18-40岁]，然后是120名幼儿[15-18个月]和120名婴儿[9-10个月]将被纳入系列。为了允许双盲，参与者将接受MRV-MNP和安慰剂(0.9%氯化钠)皮下(SC)注射或安慰剂MNP和通过SC注射的MRV(MRV-SC).局部和全身不良事件数据将在研究产品施用后收集14天。安全实验室将在第7天重复，仅在成人队列中，在第14天。将收集包括严重不良事件在内的未经请求的不良事件，直到第180天每位参与者的最终研究访问。麻疹和风疹血清中和抗体将在基线测量，在第42天和第180天。队列进展将取决于独立数据监测委员会对非盲安全性数据的审查。
结论：该试验将提供关于使用MNP递送MRV的第一个临床数据，以及关于在儿科人群中使用MNPs的第一个数据。它将指导未来的产品开发决策，这可能是未来消除麻疹和风疹的关键技术。
背景：泛非临床试验注册202008836432905。
结果：govNCT04394689。
方法：这是1/2阶段，随机，主动控制，双盲,双假人,年龄降级试验。根据确定的审判资格标准，包括筛查实验室调查，45名成人[18-40岁]，然后是120名幼儿[15-18个月]和120名婴儿[9-10个月]将被纳入系列。为了允许双盲，参与者将接受MRV-MNP和安慰剂(0.9%氯化钠)皮下(SC)注射或安慰剂MNP和通过SC注射的MRV(MRV-SC).局部和全身不良事件数据将在研究产品施用后收集14天。安全实验室将在第7天重复，仅在成人队列中，在第14天。将收集包括严重不良事件在内的未经请求的不良事件，直到第180天每位参与者的最终研究访问。麻疹和风疹血清中和抗体将在基线测量，在第42天和第180天。队列进展将取决于独立数据监测委员会对非盲安全性数据的审查。
结论：该试验将提供关于使用MNP递送MRV的第一个临床数据，以及关于在儿科人群中使用MNPs的第一个数据。它将指导未来的产品开发决策，这可能是未来消除麻疹和风疹的关键技术。
背景：泛非临床试验注册202008836432905。
结果：govNCT04394689。
