Safety and Immunogenicity Study of Recombinant Modified Vaccinia Virus Ankara (MVA) Virus to Treat HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386633
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : January 27, 2015
Information provided by:
Bavarian Nordic

October 9, 2006
October 11, 2006
January 27, 2015
October 2006
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Safety [ Time Frame: 40 w ]
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Complete list of historical versions of study NCT00386633 on Archive Site
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Safety and Immunogenicity Study of Recombinant Modified Vaccinia Virus Ankara (MVA) Virus to Treat HIV Infection
Phase I, Open, Sequential Vaccination Study on Safety and Tolerability of Two Different Doses of a Recombinant MVA HIV Polytope Vaccine (MVA-mBN32) in HIV-negative 18-50 Year Old Healthy Volunteers

At the end of 2004 there were more than 40 million people infected worldwide with HIV, with an estimated 16,000 new infections every day (Joint United Nations Programme on HIV/AIDS [UNAIDS], 2004). The HIV epidemic threatens whole societies particularly in Africa and Asia and rates of infections in the Western countries have also increased over the last few years. However, despite more than 15 years of research, an effective vaccine against HIV and acquired immunodeficiency syndrome (AIDS) has still not been developed.

There is considerable evidence that cellular immune responses can effectively control HIV-1 replication during acute and chronic infections thereby possibly protecting individuals from infection and preventing the spread of HIV. To be truly effective in the general population, a vaccine must induce responses specific to immunologically conserved regions. The epitope-based vaccine MVA-mBN32 represents a very logical approach to this problem because of its potential to elicit a polyfunctional immune response and to focus these responses to conserved epitopes.

In this study the safety, tolerability, and immunogenicity of a recombinant MVA-BN® vaccine expressing cytotoxic T lymphocyte (CTL) and helper T lymphocyte (HTL) epitopes of HIV-1 (MVA-mBN32) in 36 healthy volunteers will be examined. This will include a full analysis of CD4+ T helper cells and CD8+ CTL responses to these epitopes, to establish the potential of such a homologous prime-boost vaccine approach to induce a broad cell-mediated response to different HIV antigens.

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Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
  • Biological: MVA-mBN32
    3 immunizations; first study group: 10E7_TCID50
  • Biological: MVA-mBN32
    3 immunizations; second study group: 10E8_TCID50
  • 1
    Lower dosage: 10E7_TCID50
    Intervention: Biological: MVA-mBN32
  • Active Comparator: 2
    Intervention: Biological: MVA-mBN32
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2007
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Inclusion Criteria:

  1. Age 18 - 50
  2. Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to vaccination.
  3. Women of childbearing potential must have used an acceptable method of contraception.
  4. Troponin I within normal institutional limits.
  5. Adequate renal function
  6. Adequate hepatic function
  7. Electrocardiogram (ECG) without abnormal findings
  8. Negative HIV test for HIV-1 prior to immunization
  9. HLA-A2, HLA-A3 or HLA-B7 positive.
  10. Written informed consent of the subject after information of the risks and benefits of the study are provided in a language the subject clearly understands, and before any study specific procedure.
  11. Ultrasound of the abdomen without clinically significant abnormalities.

Exclusion Criteria:

  1. Pregnant or breast-feeding women.
  2. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
  3. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
  4. History of or suspected or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
  5. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  6. Any condition which might interfere with study objectives or would limit the subject's ability to complete the study or to be compliant in the opinion of the investigator.
  7. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
  8. History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
  9. Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool. ( NOTE: This criterion applies only to volunteers 20 years of age and older.
  10. Chronic administration (defined as more than 14 days) of systemic immuno-suppressant drugs during a period starting from six months prior to administration of the vaccine and ending at study conclusion. (Corticosteroid nasal sprays are permissible. Persons who have used topical and inhaled steroids can be enrolled after their therapy is completed).
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Monika Fluer, Bavarian Nordic
Bavarian Nordic
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Study Director: Elke Jordan, PhD Bavarian Nordic
Bavarian Nordic
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP