Safety and immunogenicity of a candidate rabies vaccine (RAB001)
Research type
Research Study
Full title
A phase I clinical trial to determine the safety and immunogenicity of the candidate rabies vaccine ChAdOx2 RabG in UK healthy adult volunteers
IRAS ID
269046
Contact name
Alexander Douglas
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance (CTRG)
Eudract number
2019-002800-41
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
Research Summary
The purpose of this study is to test a new vaccine against rabies. Rabies is a disease which is spread by the bite of infected animals. Current vaccines are expensive and require multiple doses. The new vaccine, known as ChAdOx2 RabG, aims to provide an option for rabies prevention which is more affordable and may achieve protection with a single dose.
The study will enable us to assess the safety of the new vaccine and the extent of the immune responses in healthy volunteers. We will do this by giving participants a single dose of ChAdOx2 RabG, in addition to doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first study of this vaccine in humans.
We plan to recruit 12 to 18 healthy participants to be vaccinated. Healthy volunteers aged 18-65 will be recruited in Oxford and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine and will be followed for a period of 2 months. Volunteers will be invited to return for an optional extra period of later follow-up, lasting one month and starting one year after the ChAdOx2 RabG vaccination. During this period, they will be receive an existing rabies vaccine, which will allow us to study the 'memory' immune response created by ChAdOx2 RabG.
An additional optional element of the study will include the collection of saliva samples, which will be tested for the levels of two viruses unrelated to rabies (Epstein Barr virus and cytomegalovirus). Most people in the UK carry these viruses. We wish to study the shedding of the viruses in saliva, as a precursor to using viral shedding as a biomarker in a possible future trial of a vaccine against one of these viruses.
The study is funded by the UK Medical Research Council.
Summary of Results
Thank you very much for your time and participation in the first rabies study with an adenovirus-vectored vaccine. This study was conducted among 18 adults aged 18-65 years old living in the UK. This study determined whether the rabies vaccine candidate was safe and also how well the body developed a defence (i.e., antibodies) after receiving the vaccine. The study lasted for about 4 years 6 months and there were no safety concerns reported during the trial. The vaccine also showed the human body developed a promising defence against rabies. The initial results of this study have been published (https://pubmed.ncbi.nlm.nih.gov/35907430/) and there is a plan for one further publication of the final results. Based on the results from the study you participated in, further clinical trials are currently being conducted in Tanzania in both adults and children, and there are plans for further development of this promising vaccine candidate. Your participation in this trial has enabled onward development of a vaccine with the potential to save tens of thousands of lives every year, mostly amongst children living in the world’s poorest regions. Thank you again for taking part, without people like you advances in disease prevention couldn't be made.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0408
Date of REC Opinion
1 Oct 2019
REC opinion
Further Information Favourable Opinion