This is a Phase Ib/II, open-label, head-to-head, age de-escalation dose-escalation, partially randomized trial to study the safety and immunogenicity of the candidate rabies vaccine ChAdOx2 RabG in healthy adults (age 18-45 years) and young children (age 2-6 years). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given by intradermal injection.
A total of 120 participants will be recruited into 10 groups in Bagamoyo, Tanzania. The duration of the entire study will be up to 5.5 years per participant from the time of first vaccination. ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine (Verorab) will be given by intradermal injection at two to four anatomical sites (deltoids, thighs or suprascapular areas). All participants, regardless of which vaccine they receive at the start of the study, will receive a course of a licenced rabies vaccine (Verorab) during or at the end of the follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Single dose of ChAdOx2 RabG at different concentrations: 1x10\^10 and 5x10\^10
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units
IHI Clinical Trial Facility
Bagamoyo, Tanzania
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country 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 profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country 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 profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Occurrence of serious adverse events
Time frame: SAEs will be collected from enrolment until the end of the follow-up period (Day 1839)
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country 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: Clinical Laboratory AEs to be assessed up to 28 days post vaccination
Immunogenicity of ChAdOx2 RabG administered to adults and young children residing in a rabies endemic country following primary vaccination, including the length of response maintenance, and secondary (recall) response.
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Rapid fluorescent focus inhibition test (RFFIT) of rabies virus neutralising antibody
Time frame: At Days 0, 28, 56, 186, 365, 730, 1095, 1460, 1825
Comparison of immunogenicity of ChAdOx2 RabG with a single visit two site intradermal IRV PrEP regimen
Anamnestic rabies virus neutralising antibody response as assessed by rapid fluorescent focus inhibition test (RFFIT), at 7 days following simulated rabies virus exposure through IRV administration
Time frame: At days SPEP+0 and SPEP+7