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

NCT04440774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-23

No results posted yet for this study

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

Conditions

  • Chikungunya
  • Zika

Interventions

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%)

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Abiel Homero Mascareñas de los Santos, MD · Hospital Universitario "Dr. José Eleuterio González" Universidad Autónoma de Nuevo León

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-23
Primary Completion
2022-02-18
Completion
2022-02-18

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440774 on ClinicalTrials.gov