MedTrace Logo

A Study of MVA85A, in Asymptomatic Volunteers Infected With TB, HIV or Both

NCT00480558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-03-28

No results posted yet for this study

Summary

This study is designed to evaluate the safety of MVA85A in asymptomatic volunteers in South Africa who are infected with M.tb, HIV or both. A single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, is safe and highly immunogenic in mycobacterially naïve individuals, BCG vaccinated individuals and M.tb latently infected individuals. We will use the same vaccination regime in this study. Participants will be defined as being infected with M.tb.if they have a positive Elispot response to ESAT6 or CFP10. Participants will be defined as being infected with HIV.if they have a positive HIV rapid test (Determine®, Abbott Laboratories) followed by a positive HIV ELISA result. Participants will be identified from the general population living in Worcester, Western Cape, South Africa

Conditions

  • HIV Infections
  • TB

Interventions

BIOLOGICAL

MVA 85A

Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10\^7

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Helen McShane · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • South Africa

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 NCT00480558 on ClinicalTrials.gov