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HIV InfectionsPhase 1/2NCT00390078

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

A Phase 1/2 study testing MVA-mBN32 and IMVAMUNE in people with HIV Infections, run by Bavarian Nordic at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 (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… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
HIV Infections
What is being tested?
MVA-mBN32 and IMVAMUNE
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteGermany
Study dates
Jan 2007to Jan 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female subjects, aged 18 to 50 years.
  • HIV-1 infection.
  • Stable on HAART with regard to immunologic and clinical parameters for at least 6 consecutive months prior to study entry.
  • Plasma HIV RNA level < 50 copies/ml for at least 6 months
  • Plasma HIV-1 RNA levels of < 50 copies/ml at study entry.
  • CD4 cells above 250/µl.
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  • CD4 nadir > 200/µl.
  • HLA-A2, HLA-A3 or HLA-B7 positive.
  • Laboratory criteria (all of the following must be fulfilled):
  • Adequate bone marrow reserve, Adequate renal function, Adequate hepatic function, Cardiac enzymes within normal range
  • For women, negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to each vaccination.
  • 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.
  • Read, signed and dated informed consent document.

Who cannot join

  • Pregnancy or breast-feeding.
  • Uncontrolled serious infection
  • History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the subject.
  • History of or active autoimmune disease.
  • 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.
  • History of chronic alcohol abuse (40g / day for at least 6 months) and/or intravenous drug abuse (within the past 6 month).
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  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of anaphylaxis or severe allergic reaction.
  • Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
  • Any continuous therapy that may influence CD4 counts other than anti-retroviral therapy
  • 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.
  • 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.
  • 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.
  • Prior use of any HIV vaccine or vaccinia immunization within the last 5 years.
  • Use of any investigational or non-registered drug or vaccine.
  • History or clinical manifestation of clinically significant mental illness or severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  • ECG with clinical significance.
  • History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité, Campus Virchow-Klinikum

    Berlin, 13353

Other trials in Germany

About this study

Official title: 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.

Conditions
HIV Infections
Being tested
MVA-mBN32, IMVAMUNE
Keywords
Vaccine, Safety, T-cell epitope, Acquired Immune Deficiency Syndrome Virus, HIV Therapeutic Vaccine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVA-mBN32Biological

    3 immunizations: 1x 10E8_TCID50 MVA-mBN32

  • IMVAMUNEBiological

    3 immunizations: 1x 10E8_TCID50 IMVAMUNE

Study groups in NCT00390078
Study groupRoleWhat they receive
1Active comparator20 Subjects, 1x 10E8_TCID50 MVA-mBN32
Receives: Biological: MVA-mBN32
2Placebo comparator10 Subjects 1x 10E8_TCID50 IMVAMUNE
Receives: Biological: IMVAMUNE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2007
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00390078
Sponsor's protocol ID
HIV-POL-002
Other IDs
NIAID Cont. No. N01-AI-40072
Status last verified
Jul 2009
First submitted
18 Oct 2006
Last updated
10 Jul 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MVA-mBN32 and IMVAMUNE in people with HIV Infections, run by Bavarian Nordic at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00390078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2009.

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