NCT00731471

Brief Summary

This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

2.4 years

First QC Date

August 6, 2008

Last Update Submit

March 25, 2011

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Safety of MVA85A

    Six months

Secondary Outcomes (1)

  • Immunogenicity of MVA85A

    Six months

Study Arms (2)

1

EXPERIMENTAL

12 Healthy adults infected with HIV

Biological: MVA85A

2

EXPERIMENTAL

12 HIV+ adults on antiretroviral therapy

Biological: MVA85A

Interventions

MVA85ABIOLOGICAL

Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.

12

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18 to 50 years
  • Resident in or near Dakar for the duration of the study
  • Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician
  • Willing to use effective contraception throughout duration of study (if female)
  • HIV antibody positive; diagnosed at least 6 months previously
  • CD4 count \>300
  • Arm 1: HIV viral load not \>100,000 copies per millilitre
  • Arm 2: Undetectable HIV viral load
  • Written informed consent

You may not qualify if:

  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis
  • Group 1 only: Any ARV therapy within the past 6 months
  • Previous history of TB disease and/or treatment
  • Any AIDS defining illness
  • Group 1: CD4 count nadir \<300
  • Group 2: CD4 count nadir \<100
  • CXR showing TB or evidence of other active infection
  • Prior receipt of a recombinant MVA or Fowlpox vaccine
  • Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
  • Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine (including evidence of cardiovascular disease, history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ), history of insulin requiring diabetes mellitus, any ongoing chronic illness requiring ongoing specialist supervision (e.g., gastrointestinal), and chronic or active neurological disease)
  • History of \> 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
  • Suspected or known current drug and/or alcohol abuse
  • Seropositive for hepatitis B surface antigen (HBsAg) and/ or hepatitis C (antibodies to HCV)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Dantec

Dakar, BP 7325, Senegal

Location

Related Publications (1)

  • Dieye TN, Ndiaye BP, Dieng AB, Fall M, Brittain N, Vermaak S, Camara M, Diop-Ndiaye H, Ngom-Gueye NF, Diaw PA, Toure-Kane C, Sow PS, Mboup S, McShane H. Two doses of candidate TB vaccine MVA85A in antiretroviral therapy (ART) naive subjects gives comparable immunogenicity to one dose in ART+ subjects. PLoS One. 2013 Jun 28;8(6):e67177. doi: 10.1371/journal.pone.0067177. Print 2013.

    PMID: 23840618DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Helen McShane

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Souleymane Mboup

    Centre Hospitalier Universitaire Le Dantec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 11, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

SE(1)