A Study of MVA85A, in Asymptomatic Volunteers Infected With TB, HIV or Both

This study has been completed.
Sponsor:
Collaborator:
University of Cape Town
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00480558
First received: May 30, 2007
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

This study is designed to evaluate the safety of MVA85A in asymptomatic volunteers in South Africa who are infected with M.tb, HIV or both. A single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, is safe and highly immunogenic in mycobacterially naïve individuals, BCG vaccinated individuals and M.tb latently infected individuals. We will use the same vaccination regime in this study. Participants will be defined as being infected with M.tb.if they have a positive Elispot response to ESAT6 or CFP10. Participants will be defined as being infected with HIV.if they have a positive HIV rapid test (Determine®, Abbott Laboratories) followed by a positive HIV ELISA result. Participants will be identified from the general population living in Worcester, Western Cape, South Africa


Condition Intervention Phase
HIV Infections
TB
Biological: MVA 85A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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 Asymptomatic Volunteers Who Are Infected With Either Mycobacterium Tuberculosis (M.tb.), Human Immunodeficiency Virus (HIV) or Both

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • To assess the safety of a single intradermal injection of 5 x 107p.f.u. MVA85A. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the effect of a single vaccination with MVA85A in asymptomatic participants who are infected with M.Tb or HIV or both on the immune response, both to antigen 85A (the antigen in the vaccine) and to ESAT6/CFP10 antigens (M.tb specific). [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Group 1: M. tb
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
Other Names:
  • TB Vaccine
  • modified vaccinia virus Ankara
Active Comparator: 2
Group 2: HIV (not on antiretrovirals [ARV])
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
Other Names:
  • TB Vaccine
  • modified vaccinia virus Ankara
Active Comparator: 3
Group 3: M. tb and HIV (not on ARV)
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
Other Names:
  • TB Vaccine
  • modified vaccinia virus Ankara
Active Comparator: 4
Group 4: M. tb and HIV (on ARV)
Biological: MVA 85A
Modified vaccinia Ankara virus expressing antigen 85A from M. tuberculosis. Dose is 5x10^7
Other Names:
  • TB Vaccine
  • modified vaccinia virus Ankara

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For all groups:

  • Asymptomatic adults aged 21 to 50 years
  • Chest x-ray normal with no evidence of past/present TB infection or disease or any other clinically significant finding
  • Resident in or near Worcester for the duration of the vaccination study
  • Willingness to allow the investigators to discuss the volunteer's medical history with the
  • volunteer's usual doctor or HIV physician
  • Agreement to refrain from blood donation during the course of the study
  • Willing and able to provide written informed consent
  • Willingness to undergo an HIV test

For the M.Tb infected- and M.Tb/HIV coinfected- groups:

• Screening Elispot positive (more than 50 spots/million PBMC): for either the pool of ESAT6 peptides and/or the pool of CFP10 peptides and screening Elispot positive for PPD.

• Positive Mantoux test. (>10mm induration)

For the HIV infected and M.Tb/HIV coinfected groups:

  • HIV antibody positive; diagnosed at least 3 months previously
  • CD4 count >300; nadir CD4 not < 300

Exclusion Criteria:

For all groups:

  • Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis that is considered to be clinically significant
  • Any previous ARV therapy
  • 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.)
  • Pregnant/lactating female and any female who is willing or intends to become pregnant during the study
  • Any AIDS defining illness
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Seropositive for hepatitis B surface antigen (HBsAg) and or hepatitis C (antibodies to HCV)
  • 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)
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any history of anaphylaxis in reaction to vaccination
  • PI assessment of lack of willingness to participate and comply with all requirements of the protocol
  • Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol

For the M.Tb infected group (but not the HIV infected and M.Tb/HIV coinfected groups):

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia

For the HIV infected and M.Tb/HIV coinfected groups (but not the M.Tb infected/HIV uninfected group)

  • CD4 count now more than 300 and CD4 nadir not less than 300
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480558

Locations
South Africa
University Cape Town
Cape Town, South Africa
Sponsors and Collaborators
University of Oxford
University of Cape Town
Investigators
Principal Investigator: Helen McShane University of Oxford
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Helen McShane, University of Oxford
ClinicalTrials.gov Identifier: NCT00480558     History of Changes
Other Study ID Numbers: TB011
Study First Received: May 30, 2007
Last Updated: March 25, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
HIV
MVA85A
TB
Tuberculosis
Human Immunodeficiency Virus
Safety
Immunogenicity
Efficacy
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 20, 2014