Phase I open label, non-randomised dose escalation study on healthy UK volunteers aged from 18 to 50 years to assess the safety and immunogenicity of ChAdOx1 RVF
The purpose of this study is to test a new vaccine against the Rift Valley Fever Virus (RVFV) in healthy volunteers. Rift Valley fever is a disease caused by RVFV and it is transmitted to humans through a mosquito bite or contact with virus-contaminated tissues and fluids. Although initially restricted to Africa, the virus can be transmitted by several different mosquito species that are more widely distributed than the virus itself, leading to concerns of disease spread as has occurred in the Arabian Peninsula and Madagascar. In humans, RVFV infection usually presents as a sudden febrile illness, but severe manifestations including bleeding disorders and neurological complications may also occur. RVFV is considered a global health threat with significant potential for international spread and use in bioterrorism. Vaccines against RVFV are available for livestock, however no licensed vaccines or specific treatments are currently available for humans. The study will enable assessment of the safety of the new vaccine called ChAdOx1 RVF and the extent of immune response in healthy volunteers. Healthy adult volunteers will receive a single dose of a new candidate vaccine at different doses. The objective of this first-in-human study is to find the optimal dose of the vaccine, balancing immune responses and profile of adverse events. Healthy volunteers aged 18-50 will be recruited in Oxford and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine and will be followed for a period of 3 months. The study is funded by the UK Biotechnology and Biological Sciences Research Council(BBSRC) and the Medical Research Council (MRC)/Department of Health, through the UK Vaccines Network.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Single dose of ChAdOx1 RVF
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
To assess local reactogenicity
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: 7 days following vaccination
To assess systemic reactogenicity
Occurrence of solicited systemic reactogenicity signs and symptoms
Time frame: 7 days following vaccination
To assess unsolicited adverse events
Occurrence of unsolicited adverse events
Time frame: 28 days following vaccination
To assess the safety and tolerability of ChAdOx1 RVF in healthy adult volunteers
Frequency of participants with clinically significant changes from baseline safety laboratory measures (haematology and biochemistry blood results)
Time frame: Duration of study (6 months)
To assess serious adverse events
Occurrence of serious adverse events
Time frame: Duration of study (6 months)
Assess the cellular and humoral immunogenicity of ChAdOx1 RVF in healthy adult volunteers
ELISA to quantify antibodies to GnGc proteins
Time frame: Duration of study (6 months)
Assess the cellular and humoral immunogenicity of ChAdOx1 RVF in healthy adult volunteers
RVFV neutralising antibody titres
Time frame: Duration of study (6 months)
Assess the cellular and humoral immunogenicity of ChAdOx1 RVF in healthy adult volunteers
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Ex vivo ELISpot and flow cytometry responses to GnGc
Time frame: Duration of study (6 months)