ISRCTN34189114 - A phase I study evaluating the safety and immunogenicity of a new tuberculosis (TB) vaccine, MVA85A, in healthy volunteers who are infected with human immunodeficiency virus (HIV)

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11 February 2012

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A phase I study evaluating the safety and immunogenicity of a new tuberculosis (TB) vaccine, MVA85A, in healthy volunteers who are infected with human immunodeficiency virus (HIV)

ISRCTN	ISRCTN34189114
ClinicalTrials.gov identifier	NCT00395720
Public title	A phase I study evaluating the safety and immunogenicity of a new tuberculosis (TB) vaccine, MVA85A, in healthy volunteers who are infected with human immunodeficiency virus (HIV)
Scientific title	The safety and immunogenicity of a new tuberculosis (TB) vaccine, MVA85A, in healthy volunteers who are infected with human immunodeficiency virus (HIV): an open label phase I study
Acronym	N/A
Serial number at source	076943; TB010
Study hypothesis	This is an open label phase I study of the safety and immunogenicity of two doses of MVA85A in healthy subjects who are infected with human immunodeficiency virus (HIV). Volunteers will be recruited sequentially into two groups: Group 1 (10 volunteers): vaccinated with 5 x 10^7 pfu MVA85A Group 2 (10 volunteers): vaccinated with 1 x 10^8 pfu MVA85A
Lay summary
Ethics approval	Gene Therapy Advisory Committee (GTAC) approved on the 12th May 2006 (ref: GTAC 116; EudraCT No.: 2006-000076-32)
Study design	Open label two arm active-controlled phase I study
Countries of recruitment	United Kingdom
Disease/condition/study domain	Human immunodeficiency virus (HIV), tuberculosis (TB)
Participants - inclusion criteria	1. Healthy adults aged 18 to 55 years (both male and female) 2. Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician (and GP, if appropriate) 3. HIV antibody positive; diagnosed at least 6 months previously 4. CD4 count greater than 350; nadir CD4 not less than 300 5. HIV viral load not greater than 100,000 copies per ml 6. Written informed consent
Participants - exclusion criteria	1. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis 2. Any anti-retroviral (ARV) therapy within the past 6 months 3. Any acquired immune deficiency syndrome (AIDS) defining illness 4. Chest x-ray (CXR) showing tuberculosis (TB) or evidence of other active infection 5. Prior receipt of a recombinant MVA or Fowlpox vaccine 6. 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 7. 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, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) 8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products 9. 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) 10. History of greater than two hospitalisations for invasive bacterial infections (pneumonia, meningitis) 11. Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of greater than 42 units a week) 12. Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis C (antibodies to HCV) 13. Evidence of serious psychiatric condition 14. Any other on-going chronic illness requiring hospital specialist supervision 15. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate 16. Pregnant/lactating female and any female who is willing or intends to become pregnant during the study 17. Any history of anaphylaxis in reaction to vaccination 18. 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
Anticipated start date	01/10/2006
Anticipated end date	01/08/2010
Status of trial	Completed
Patient information material	Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants	20
Interventions	MVA85A is a modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Ten subjects will receive a single intradermal vaccination of 5 x 10^7 pfu (plaque forming units) of MVA85A and ten will receive a single intradermal vaccination of 1 x 10^8 pfu MVA85A. There is no control group. Follow up is for 12 months.
Primary outcome measure(s)	To assess the safety of a single intradermal injection of MVA85A, when administered to healthy subjects who are infected with HIV. Safety is measured throughout the one year follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84, 168 and 364. Blood for safety testing is taken at Days 7 and 28.
Secondary outcome measure(s)	To assess the immunogenicity of a single intradermal injection of MVA85A, when administered to healthy subjects who are infected with HIV. Immunogenicity is measured throughout the one year follow up period, but specifically on the following days: 7, 14, 28, 56, 84, 168 and 364.
Sources of funding	The Wellcome Trust (UK) - Senior Clinical Fellowship Grant (grant ref: 076943)
Trial website
Publications
Contact name	Dr Helen McShane
Address	Jenner Institute Old Road Campus Research Building University of Oxford
City/town	Oxford
Zip/Postcode	OX3 7DQ
Country	United Kingdom
Sponsor	University of Oxford (UK)
Address	Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital
City/town	Oxford
Zip/Postcode	OX3 7LJ
Country	United Kingdom
Sponsor website:	http://www.ox.ac.uk/
Date applied	14/12/2009
Last edited	18/12/2009
Date ISRCTN assigned	18/12/2009


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