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ChAdOx1 85A Aerosol Versus Intramuscular Vaccination in Healthy Adults (TB039)

NCT04121494 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-09-25

No results posted yet for this study

Summary

This is a dose escalating and a paired-placebo design study to describe the safety and immunogenicity profile of candidate TB vaccine ChAdOx1 85A given by aerosol inhaled vaccination versus intramuscular (IM) vaccination in adult healthy volunteers.

It is postulated that the aerosol inhaled route is practical and feasible and has an acceptable safety profile, comparable to the systemic safety profile of the IM route of administration of ChAdOx1 85A in adult healthy volunteers, and that the aerosol inhaled route of administration will induce greater mucosal immunity and comparable systemic immunity when compared to the IM (systemic) route of administration in these volunteers.

Volunteers are followed on a regular basis for safety and immunogenicity, with blood analysis for biological safety tests and immune tests.

Conditions

  • Mycobacterium Tuberculosis, Protection Against
  • Tuberculosis

Interventions

BIOLOGICAL

ChadOx1 85A - aerosol

Aerosol administration through the Omron MicroAIR NE-U22 nebuliser

BIOLOGICAL

ChadOx1 85A - IM

Intramuscular administration

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • François Spertini

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2020-08-24
Completion
2020-08-24

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04121494 on ClinicalTrials.gov