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CompletedNCT00386633Updated Jan 27, 2015

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

A Phase 1 interventional study of MVA-mBN32 and MVA-mBN32 in HIV Infections, sponsored by Bavarian Nordic. Completed at 1 site in Germany. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Bavarian Nordic · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • HIV Infections

Keywords

  • Vaccine
  • Safety
  • T-cell epitope
  • Acquired Immune Deficiency Syndrome Virus
  • HIV Preventive Vaccine
03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 36 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) 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).
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Other
    1

    Lower dosage: 10E7\_TCID50

    Biological: MVA-mBN32

  • Active comparator
    2

    10E8\_TCID50

    Biological: MVA-mBN32

Interventions

  • BiologicalMVA-mBN32

    3 immunizations; first study group: 10E7\_TCID50

  • BiologicalMVA-mBN32

    3 immunizations; second study group: 10E8\_TCID50

06

What researchers measure

Primary outcomes

  1. Safety

    Time frame: 40 w

07

Study locations

1 site
  • LMU-Munich, Department of Infectious Diseases and Tropical Medicine
    Munich, 80799, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00386633
Lead sponsor
Bavarian Nordic
First posted
Oct 11, 2006
Start date
Oct 2006
Completion
Nov 2007
Last update
Jan 27, 2015

Study contacts

Elke Jordan, PhD
study director · Bavarian Nordic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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