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

Purpose

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.

Condition	Intervention	Phase
Tuberculosis	Biological: MVA85A	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:

Safety of MVA85A [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity of MVA85A [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	August 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 12 Healthy adults infected with HIV	Biological: MVA85A Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.
Experimental: 2 12 HIV+ adults on antiretroviral therapy	Biological: MVA85A Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731471

Locations

Senegal
Centre Hospitalier Le Dantec
Dakar, Senegal, BP 7325

Sponsors and Collaborators

University of Oxford

Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal

Investigators

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

More Information

No publications provided

Responsible Party:	Dr Helen McShane, University of Oxford
ClinicalTrials.gov Identifier:	NCT00731471 History of Changes
Other Study ID Numbers:	TB019
Study First Received:	August 6, 2008
Last Updated:	March 25, 2011
Health Authority:	Senegal: Ministere de la sante

Additional relevant MeSH terms:

Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 21, 2013