This is a FIH, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 Zika vaccine in healthy volunteers administered intramuscularly.
Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and a total of 24 volunteers will be enrolled. Groups 1-3 will receive ChAdOx1 Zika alone. Staggered enrolment will apply for the first three volunteers within each group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single dose of ChAdOx1 Zika 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 ChAdOx1 Zika given as a standalone vaccine at different doses in healthy adult volunteers 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 and nausea).
Time frame: Assessment of solicited AEs in the first 7 days post vaccination.
Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine at different doses in healthy adult volunteers assessed by the occurrence of unsolicited 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 ChAdOx1 Zika given as a standalone vaccine at different doses in healthy adult volunteers 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 (i.e. 6 months)
Safety and tolerability of ChAdOx1 Zika given as a standalone vaccine at different doses in healthy adult volunteers assessed by the occurrence of laboratory 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 and day 28 post vaccination
Measures of humoral immunogenicity to the ChAdOx1 ZIKA vaccine
ELISA to quantify antibodies to ZIKV protein antigens
Time frame: At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360
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Measures of cellular immunogenicity to the ChAdOx1 ZIKA vaccines
Ex vivo interferon gamma ELISpot responses to ZIKV protein antigens
Time frame: At days 0, 7, 14, 28, 56, 90 and 182 + extended visit days 270 and 360