Project Title: A Phase 1b age de-escalation, dose escalation, partially randomised, open-label head-to-head study of the safety and immunogenicity of the candidate rabies vaccine ChAdOx2 RabG
Project Description: Rabies is neglected tropical disease caused by enveloped, single-stranded RNA virus of the Rhabdoviridae family. The rabies virus (RABV) genome consists of five genes encoding glycoprotein, matrix protein, nucleoprotein, phosphoprotein, and the viral RNA polymerase. Rabies caused significant mortality and hardship globally, particularly in low and middle-income countries where it is endemic. Its control is multifaceted, including pre-exposure prophylaxis (PrEP) and PEP in humans, and vaccination of animal reservoirs. Although both pre and post exposure... Rabies is neglected tropical disease caused by enveloped, single-stranded RNA virus of the Rhabdoviridae family. The rabies virus (RABV) genome consists of five genes encoding glycoprotein, matrix protein, nucleoprotein, phosphoprotein, and the viral RNA polymerase. Rabies caused significant mortality and hardship globally, particularly in low and middle-income countries where it is endemic. Its control is multifaceted, including pre-exposure prophylaxis (PrEP) and PEP in humans, and vaccination of animal reservoirs. Although both pre and post exposure prophylaxis is available, costs for both are too high, which coupled with the need multiple visits, prevents their full potential being realised. However, these existing control measures are inadequate, hence the need for new vaccine. Rabies glycoprotein (RabG) is the key surface antigen against which protective neutralising virus antibodies are induced by currently available vaccines. The primary objective of this trial is to assess the safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) abd young children (1-6 years) residing in rabies-endemic country. The secondary objective is to assess immunogenicity of ChAdOx2 RabG administered to adults and young children residing in a rabies endemic country following primary vaccination and secondary (recall) response. The study will take place at IHI Clinical Trial Facility (CTF) located in Bagamoyo town. The facility has clinical consultation rooms, a pharmacy, vaccination room, data management room and an observation area for study participants. There is a resuscitation room that is equipped with oxygen, suction, defibrillator and resuscitation kits. The clinical trial facility has experienced trained staff around Bagamoyo town in Bagamoyo district. After approval from ethics committees, local authorities will be informed about the study in order to receive permission to approach in the community. A series of meetings will then be held to explain in the study to the potential participants in the community. Screening procedures will only start once a participant or parent/guardian has provided a written informed consent and continue until all participants and at least 2 back up participants have been enrolled into the study. Only participants who meet eligibility criteria and have signed/thumb printed the informed consent will undergo a full screening procedure. All final analyses of clinical safety data will performed by the PI with the support from sponsor and IHI statisticians. Final analysis of data relating to immunogenicity as part of the secondary and exploratory objective of this study will be carried out under the guidance of the CI and PI. Data from study may also be used as part of a thesis for a PhD, MD or Masters The final safety report will be prepared by the PI. The protocol and data derived from the trial are the shared property of the IHI and the University Of Oxford University. Any publication or presentation, abstracts and press releases related to the trial must be approved by all parties representatives before submission of the manuscript. Publications arising from this study will be made open access.
Principal Investigator : Ally Olotu
Department Name : BRCT
Time frame: (2020-01-22) - (2028-05-23)
The Chancellor Masters and University of Oxford (Normal)
External Collaborating Partners
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