The Safety and Immunogenicity of a TB Vaccine; MVA85A, in Healthy Volunteers Who Are Infected With HIV
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This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 10^7pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. Additionally, 5 x 10^7 pfu MVA containing HIV antigens administered twice, 4 weeks apart, in HIV positive individuals, is safe. We will use 5 x 107 pfu MVA85A intradermally in this study. Subjects will be identified from HIV clinics in the Oxford Radcliffe Hospitals NHS Trust and also from Swindon and Marlborough NHS Trust and St. Mary's Hospital NHS Trust if our recruitment targets are not met.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis HIV Infections |
Biological: MVA85A (TB vaccine) Biological: MVA 85A |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel 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 |
- Data on adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Immune responses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Estimated Enrollment: | 20 |
Study Start Date: | November 2006 |
Study Completion Date: | July 2010 |
Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1
Group 1 (10 volunteers): 5 x 10^7 pfu
|
Biological: MVA85A (TB vaccine)
Intradermal vaccine
Other Name: TB vaccine
Biological: MVA 85A
Intradermal vaccine
Other Names:
|
Active Comparator: 2
Group 2 (10 volunteers): 1 x 10^8 pfu
|
Biological: MVA85A (TB vaccine)
Intradermal vaccine
Other Name: TB vaccine
Biological: MVA 85A
Intradermal vaccine
Other Names:
|
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adults aged 18 to 50 years
- Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician (and GP, if appropriate)
- BCG vaccinated
- HIV antibody positive; diagnosed at least 6 months previously
- CD4 count >350; nadir CD4 not < 300
- HIV viral load not > 100,000 copies per millilitre
- Written informed consent
Exclusion Criteria:
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis
- Any ARV therapy within the past 6 months
- Any AIDS defining illness
- 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 (as defined by an alcohol intake of >42 units a week)
- 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
- 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
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United Kingdom | |
Centre for Clinical Vaccinology and Tropical Medicine | |
Oxford, Oxfordshire, United Kingdom, OX3 7LJ |
Principal Investigator: | Helen McShane, Dr | University of Oxford |
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Publications:
Responsible Party: | Dr Helen McShane, University of Oxford |
ClinicalTrials.gov Identifier: | NCT00395720 History of Changes |
Other Study ID Numbers: | TB010 |
Study First Received: | November 2, 2006 |
Last Updated: | March 25, 2011 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Oxford:
TB Tuberculosis HIV |
Vaccine MVA85A HIV Therapeutic Vaccine |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on March 03, 2013