Single-Blind, Controlled Safety and Immunogenicity Study of Recombinant MVA Virus to Treat HIV Infection

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00390078
First received: October 18, 2006
Last updated: July 9, 2009
Last verified: July 2009

October 18, 2006
July 9, 2009
January 2007
December 2007   (final data collection date for primary outcome measure)
To compare the safety and reactogenicity of the recombinant MVA-mBN32 expressing functional HIV epitopes and MVA-BN® following repeated vaccination in HIV-1 infected patients [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00390078 on ClinicalTrials.gov Archive Site
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Single-Blind, Controlled Safety and Immunogenicity Study of Recombinant MVA Virus to Treat HIV Infection
Single-Blind, Randomized, Controlled, Phase I/II Vaccination Study on Safety and Immunogenicity of a Recombinant MVA-HIV Polytope Vaccine (MVA-mBN32) in HIV-1 Infected Patients With CD4 Counts > 250/µl

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 (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 represent a very logical approach to this problem because 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® expressing CTL and HTL epitopes of HIV-1 (MVA-mBN32) vs. the vector control MVA-BN® in 30 HIV-infected subjects 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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
HIV Infections
  • Biological: MVA-mBN32
    3 immunizations: 1x 10E8_TCID50 MVA-mBN32
  • Biological: IMVAMUNE
    3 immunizations: 1x 10E8_TCID50 IMVAMUNE
  • Active Comparator: 1
    20 Subjects, 1x 10E8_TCID50 MVA-mBN32
    Intervention: Biological: MVA-mBN32
  • Placebo Comparator: 2
    10 Subjects 1x 10E8_TCID50 IMVAMUNE
    Intervention: Biological: IMVAMUNE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2009
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female subjects, aged 18 to 50 years.
  2. HIV-1 infection.
  3. Stable on HAART with regard to immunologic and clinical parameters for at least 6 consecutive months prior to study entry.
  4. Plasma HIV RNA level < 50 copies/ml for at least 6 months
  5. Plasma HIV-1 RNA levels of < 50 copies/ml at study entry.
  6. CD4 cells above 250/µl.
  7. CD4 nadir > 200/µl.
  8. HLA-A2, HLA-A3 or HLA-B7 positive.
  9. Laboratory criteria (all of the following must be fulfilled):

    Adequate bone marrow reserve, Adequate renal function, Adequate hepatic function, Cardiac enzymes within normal range

  10. For women, negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to each vaccination.
  11. If the volunteer is female and of childbearing potential, she has used adequate contraceptive precautions for 30 days prior to the first vaccination and agrees to use an acceptable method of contraception, and not become pregnant for at least 56 days after the last vaccination.
  12. Read, signed and dated informed consent document.

EXCLUSION CRITERIA:

  1. Pregnancy or breast-feeding.
  2. Uncontrolled serious infection
  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 active autoimmune disease.
  5. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
  6. History of chronic alcohol abuse (40g / day for at least 6 months) and/or intravenous drug abuse (within the past 6 month).
  7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  8. History of anaphylaxis or severe allergic reaction.
  9. Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
  10. Any continuous therapy that may influence CD4 counts other than anti-retroviral therapy
  11. Any vaccinations with live vaccines within a period starting 30 days prior to administration of the vaccine and ending 30 days after administration of the study vaccine. Any vaccinations with killed vaccines within a period starting 14 days prior to administration of the study vaccine and ending 14 days after administration of the study vaccine.
  12. Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs during a period starting from six months prior to administration of the vaccine and ending at study conclusion.
  13. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
  14. Prior use of any HIV vaccine or vaccinia immunization within the last 5 years.
  15. Use of any investigational or non-registered drug or vaccine.
  16. History or clinical manifestation of clinically significant mental illness or severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  17. ECG with clinical significance.
  18. History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
  19. 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. (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00390078
HIV-POL-002, NIAID Cont. No. N01-AI-40072
Not Provided
Monika Fluer, Bavarian Nordic
Bavarian Nordic
National Institutes of Health (NIH)
Study Director: Johannes Hain, PhD Bavarian Nordic
Bavarian Nordic
July 2009

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