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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00731471
• Date of registration: 06/08/2008
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV
• Scientific title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV
• Date of first enrolment: August 2008
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00731471
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Senegal

Contacts

• Name: Souleymane Mboup
• Affiliation: Centre Hospitalier Universitaire Le Dantec

• Name: Helen McShane
• Affiliation: University of Oxford

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: MVA85A

Primary Outcome(s)

Safety of MVA85A [Time Frame: Six months]

Secondary Outcome(s)

Immunogenicity of MVA85A [Time Frame: Six months]

Secondary ID(s)

TB019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal