A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV

This study has been completed.

Sponsor:

Collaborator:

Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal

Information provided by:

University of Oxford

ClinicalTrials.gov Identifier:

NCT00731471

First received: August 6, 2008

Last updated: March 25, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 6, 2008

Last Updated Date

March 25, 2011

Start Date ^ICMJE

August 2008

Primary Completion Date

January 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety of MVA85A [ Time Frame: Six months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00731471 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Immunogenicity of MVA85A [ Time Frame: Six months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV

Official Title ^ICMJE

A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV

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.

Detailed Description

This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. We will use 1 x 10^8 pfu MVA85A intradermally in this study. A trial in BCG vaccinated subjects showed that the higher dose (1 x 10^8 pfu MVA85A) induced a significantly higher immune response but did not have a higher AE profile. In addition, because of a variable immune response, the trial in HIV positive subjects in the UK is split into two groups, the first getting 5 x 10^7 pfu and the second getting 1 x 10^8 pfu MVA85A. It has, therefore, been decided to use the higher dose in order to maximise the immune response whilst maintaining a good safety profile.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Condition ^ICMJE

Tuberculosis

Intervention ^ICMJE

Biological: MVA85A

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

Study Arms

Experimental: 1
12 Healthy adults infected with HIV

Intervention: Biological: MVA85A
Experimental: 2
12 HIV+ adults on antiretroviral therapy

Intervention: Biological: MVA85A

Publications *

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) naïve 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. Erratum in: PLoS One. 2013;8(10). doi:10.1371/annotation/67550546-cacf-4063-8d62-d165da14ca61. Britain, Nathaniel [corrected to Brittain, Nathaniel].

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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)
Evidence of serious psychiatric condition
Any other on-going chronic illness requiring hospital specialist supervision
Any confirmed or suspected immunosuppressive or immunodeficient condition, other than HIV infection, such as asplenia
Evidence of hepatomegaly
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
Pregnant/lactating female and any female who is willing or intends to become pregnant during the study
Any history of anaphylaxis in reaction to vaccination
PI assessment of lack of willingness to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Senegal

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00731471

Other Study ID Numbers ^ICMJE

TB019

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Dr Helen McShane, University of Oxford

Study Sponsor ^ICMJE

University of Oxford

Collaborators ^ICMJE

Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal

Investigators ^ICMJE

Principal Investigator:	Helen McShane	University of Oxford
Principal Investigator:	Souleymane Mboup	Centre Hospitalier Universitaire Le Dantec

PRS Account

University of Oxford

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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