NCT04440774

Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.

A Single Centre, Double-blind, Double-dummy Placebo-controlled, Randomised Phase Ib Study to Evaluate the Safety & Immunogenicity of the Candidate Chikungunya Vaccine ChAdOx1 Chik & the Zika Vaccine ChAdOx1 Zika in Healthy Adults in Mexico

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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)

Conditions

• Chikungunya
• Zika

Interventions

Type	Name	Description
BIOLOGICAL	CHIK low dose	A single dose of 5x10\^9 vp ChAdOx1 Chik
BIOLOGICAL	CHIK mid dose	A single dose of 2.5x10\^10 vp ChAdOx1 Chik
BIOLOGICAL	CHIK high dose	A single dose of 5x10\^10 vp ChAdOx1 Chik
BIOLOGICAL	ZIKA low dose	A single dose of 5x10\^9 vp ChAdOx1 Zika
BIOLOGICAL	ZIKA mid dose	A single dose of 2.5x10\^10 vp ChAdOx1 Zika
BIOLOGICAL	ZIKA high dose	A single dose of 5x10\^10 vp ChAdOx1 Zika
BIOLOGICAL	Saline placebo	A single dose of isotonic saline solution (0.9%)

Timeline

• Start date: 2020-10-23
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2020-06-22
• Last updated: 2022-03-23

Locations

1 site across 1 country: Mexico