This is a first-in-human, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx2 RabG vaccine in healthy UK volunteers aged 18-65. The vaccine will be administered intramuscularly (IM).
Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and it is anticipated that a total of 12 volunteers will be enrolled. Staggered enrolment will apply between study groups and for the first three volunteers within each group. The study includes an optional extended follow-up period, lasting one month and starting one year after vaccination. Volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine, allowing study of the immunological memory (recall response) induced by ChAdOx2 RabG. A second optional element of the study is the collection of saliva samples at each visit for the study of shedding of EBV and CMV.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache, fatigue and nausea).
Time frame: Assessment of solicited AEs in the first 7 days post vaccination
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Occurrence of unsolicited local and systemic adverse events
Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination.
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of serious adverse events.
Occurrence of serious adverse events
Time frame: SAEs will be collected from enrolment until the end of the follow-up period.(8 weeks)
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
Time frame: At Day 0 (baseline), day 2, day 7, day 28 and day 56 post vaccination
Immunogenicity of the ChAdOx2 RabG vaccine
Rapid fluorescent focus inhibition test (RFFIT) of virus neutralising antibody
Time frame: Day 365
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Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp.
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.