Phase Ib, single centre, double-blind, double-dummy placebo-controlled, randomised, stepwise dose escalated, vaccine trial to assess the safety and immunogenicity of the candidate ChAdOx1 Chik and ChAdOx1 Zika vaccines, given as a standalone vaccines or in co-administration. Healthy volunteers aged 18-50 years old, residents of the metropolitan area of Monterrey (Mexico), will be recruited as participants
This trial consists of 4 intervention arms according to the vaccination product: 1) ChAdOx1 Chik, 2) ChAdOx1 Zika, 3) ChAdOx1 Chik and ChAdOx1 Zika as contralateral co-administration, and 4) placebo. There will be a total of 120 participants divided in ten study groups with 12 participants per group (Table 5.1). Groups 1 to 3 will receive ChAdOx1 Chik + placebo administered contralaterally, Groups 4 to 6 will receive ChAdOx1 Zika + placebo administered contralaterally, and Groups 7 to 9 will receive both ChAdOx1 Chik and ChAdOx1 Zika administered contralaterally. Group 10 will receive placebo in both arms. Enrolment into this study will be implemented in a step-wise dose escalation manner. Participants will be first recruited into the vaccination groups at the lowest dose (Groups 1, 4 and 7). It is only after completion of these low dose groups and upon satisfactory interim clinical safety reviews that participants will be enrolled into the mid dose groups (Groups 2, 5 and 8). Participants in the high dose groups (Groups 3, 6 and 9) will be enrolled last, after completion and interim clinical safety reviews from the mid dose groups. Participants allocated to the Placebo group (Group 10) will be evenly distributed across the dose escalation model. Randomisation procedures will be implemented accordingly, at a ratio of 3:3:3:1 for each of the four intervention arms. The study involves a total of 9 visits (screening inclusive) and follow up will be undertaken for 6 months after vaccination day Innovate UK (project number 971557)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
A single dose of 5x10\^9 vp ChAdOx1 Chik
A single dose of 2.5x10\^10 vp ChAdOx1 Chik
A single dose of 5x10\^10 vp ChAdOx1 Chik
Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León.
Monterrey, Nuevo León, Mexico
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of local reactogenicity signs and symptoms
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination.
Time frame: 7 days post vaccination
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of solicited systemic reactogenicity signs and symptoms
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination.
Time frame: 7 days post vaccination
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of unsolicited adverse events
Occurrence of unsolicited adverse events for 28 days following vaccination
Time frame: 28 days post vaccination
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants through standard blood tests (full blood count, liver and kidney function tests)
Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Time frame: 28 days post vaccination
Assess the safety profile and tolerability of ChAdOx1 Chik and ChAdOx1 Zika in healthy participants: occurrence of serious adverse events during the whole study duration
Occurrence of serious adverse events during the whole study duration
Time frame: 6 months post vaccination
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via PRNT50
Plaque-reduction neutralisation tests at 50% (PRNT50) against chikungunya and Zika virus.
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A single dose of 5x10\^9 vp ChAdOx1 Zika
A single dose of 2.5x10\^10 vp ChAdOx1 Zika
A single dose of 5x10\^10 vp ChAdOx1 Zika
A single dose of isotonic saline solution (0.9%)
Time frame: 6 months post vaccination
Assess the humoral immunogenicity of the candidate vaccines ChAdOx1 Chik and ChAdOx1 Zika via IgG ELISA antibody titres
IgG ELISA antibody titres against proteins of Chikungunya and Zika virus
Time frame: 6 months post vaccination