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Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine

NCT00800670 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-09-08

No results posted yet for this study

Summary

The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers. 48 subjects will be recruited, 24 who have previously been vaccinated with BCG and 24 who have not received BCG vaccine. Two doses of the vaccine will be compared.

Conditions

Interventions

BIOLOGICAL

Ad5Ag85A

Single intra-muscular administration of 10\^8 pfu of recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)

BIOLOGICAL

Ad5Ag85A

Single intra-muscular administration of 10\^9 recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)

Sponsors & Collaborators

Principal Investigators

  • Zhou Xing, PhD · McMaster University

  • Fiona M Smaill, MD · McMaster University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT00800670 on ClinicalTrials.gov