MedTrace Logo

A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A

NCT00653770 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2010-02-09

No results posted yet for this study

Summary

This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG. The secondary outcome is to assess the cellular immune response in the same population. The trial consists of 36 subjects in 3 groups. The first group will be vaccinated with FP85A alone, the second group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will be vaccinated with FP85A followed by MVA85A 28 days later.

Conditions

Interventions

BIOLOGICAL

FP85A

Recombinant Fowlpox virus 9 expressing antigen 85A from M. tuberculosis (5 x10\^7 pfu)

BIOLOGICAL

MVA85A

Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis (5 x 10\^7 pfu)

Sponsors & Collaborators

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00653770 on ClinicalTrials.gov