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The Safety and Immunogenicity of a TB Vaccine; MVA85A, in Healthy Volunteers Who Are Infected With HIV

NCT00395720 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-03-28

No results posted yet for this study

Summary

This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 10\^7pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. Additionally, 5 x 10\^7 pfu MVA containing HIV antigens administered twice, 4 weeks apart, in HIV positive individuals, is safe. We will use 5 x 107 pfu MVA85A intradermally in this study. Subjects will be identified from HIV clinics in the Oxford Radcliffe Hospitals NHS Trust and also from Swindon and Marlborough NHS Trust and St. Mary's Hospital NHS Trust if our recruitment targets are not met.

Conditions

Interventions

BIOLOGICAL

MVA85A (TB vaccine)

Intradermal vaccine

BIOLOGICAL

MVA 85A

Intradermal vaccine

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Helen McShane, Dr · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United Kingdom

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 NCT00395720 on ClinicalTrials.gov