HIV InfectionsPhase 1/2NCT00189904
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients
A Phase 1/2 study testing IMVAMUNE (MVA-BN) in people with HIV Infections, run by Bavarian Nordic at 5 sites in United States.
Trial summary
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- IMVAMUNE (MVA-BN)
- How many people
- 151 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2005to not given
- 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 55 years
- All sexes
- Adult
Who may be able to join
- Male subjects between 18 and 49 years of age or female subjects between 18 and 55 years of age who provided informed consent.
- Women with negative pregnancy test.
- Women of childbearing potential must use an acceptable method of contraception.
- Cardiac enzymes within ULN.
- White blood cells ≥ 2500/mm3 and < 11,000/ mm3.
- Absolute neutrophil count ≥ 1000/mm3.
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- Adequate renal function.
- Adequate hepatic function.
- Negative hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
- Negative antibody test to hepatitis C virus (HCV).
- Negative urine glucose by dipstick or urinalysis.
- Normal 12-lead electrocardiogram.
- Availability for follow-up during the study.
- Groups 1 and 3 (All vaccinia-naïve subjects) additionally:
- No history of known or suspected previous smallpox vaccination.
- No detectable vaccinia scar.
- No military service prior to 1989 or after January 2003.
- Groups 2 and 4 (All previously vaccinated subjects) additionally:
- History of at least one previous smallpox vaccination
- Time since most current smallpox vaccination > 10 years.
- Groups 1 and 2 (All HIV Infected subjects) additionally:
- Documented HIV-1 infection
- Plasma HIV-1 RNA level < 400 copies/mL at screening.
- CD4 cells ≥ 350/µL
- Haemoglobin ≥ 9.0 g/dL.
- Platelets ≥ 100,000/mm3.
- AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN
- Groups 3 and 4 (All Healthy subjects) additionally:
- Negative ELISA for HIV.
- Haemoglobin >11 g/dL.
- Platelets ≥ 140,000/mm3.
- AST (SGOT), ALT (SGPT) and alkaline phosphatase without clinically significant findings
Who cannot join
- Pregnant or breast-feeding women.
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of any serious medical condition (other than HIV infection).
- History of or active autoimmune disease.
- Known or suspected impairment of immunologic function (other than HIV infection).
- History of malignancy.
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- History or clinical manifestation of clinically significant and severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- Clinically significant mental disorder not adequately controlled by medical treatment.
- Any condition which might interfere with study objectives.
- 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.
- History of an immediate family member with onset of ischemic heart disease before age 50.
- 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.
- History of chronic alcohol abuse and/or intravenous drug abuse.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Known previous allergic reaction to immunoglobulins.
- Known allergies to cidofovir or probenecid.
- History of anaphylaxis or severe allergic reaction.
- Acute disease (illness with or without a fever) at the time of enrollment.
- Temperature >100.4°F at the time of enrollment.
- Subjects undergoing treatment for tuberculosis infection or disease.
- Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
- Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after study vaccination.
- Chronic administration of immuno-suppressant or immune-modifying drugs.
- Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- Administration or planned administration of immunoglobulins and/or any blood products.
- Use of any investigational or non-registered drug or vaccine.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Indiana University School of Medicine
Indianapolis, Indiana, 46202-2859
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0093
Vanderbilt AIDS Clinical Trials Center
Nashville, Tennessee, 37203
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6073
Washington University School of Medicine
St Louis, Missouri
About this study
Official title: A Multicenter, Open-label Phase I/II Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in HIV Infected Subjects (CD4 Counts >350 / µl) and Healthy Subjects With and Without Previous Smallpox Vaccination
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.
- Conditions
- HIV Infections
- Being tested
- IMVAMUNE (MVA-BN)
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVAMUNE (MVA-BN)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study
Secondary outcomes (2)
Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points)
ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard N Greenberg, M.D., Principal investigator, University of Kentucky School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189904
- Sponsor's protocol ID
- POX-MVA-010
- Other IDs
- HHSN266200400072C
- Status last verified
- Dec 2007
- First submitted
- 11 Sep 2005
- Last updated
- 28 Sep 2012
- Results posted
- No
Publications
Greenberg RN, Overton ET, Haas DW, Frank I, Goldman M, von Krempelhuber A, Virgin G, Badeker N, Vollmar J, Chaplin P. Safety, immunogenicity, and surrogate markers of clinical efficacy for modified vaccinia Ankara as a smallpox vaccine in HIV-infected subjects. J Infect Dis. 2013 Mar 1;207(5):749-58. doi: 10.1093/infdis/jis753. Epub 2012 Dec 7.
PubMed 23225902
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase I/II Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in HIV Infected Subjects (CD4 Counts >350 / µl) and Healthy Subjects With and Without Previous Smallpox Vaccination
- ClinicalTrials.gov ID
- NCT00189904
- Acronym / sponsor ID
- POX-MVA-010
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2005
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (32 listed)
- Male subjects between 18 and 49 years of age or female subjects between 18 and 55 years of age who provided informed consent.
- Women with negative pregnancy test.
- Women of childbearing potential must use an acceptable method of contraception.
- Cardiac enzymes within ULN.
- White blood cells ≥ 2500/mm3 and < 11,000/ mm3.
Key exclusion criteria (26 listed)
- Pregnant or breast-feeding women.
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of any serious medical condition (other than HIV infection).
- History of or active autoimmune disease.
- Known or suspected impairment of immunologic function (other than HIV infection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMVAMUNE (MVA-BN) | Biological | – |
Primary outcome
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study
2 secondary outcomes
Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points)
ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Derived from this study: PubMed 23225902Greenberg RN, Overton ET, Haas DW, Frank I, Goldman M, von Krempelhuber A, Virgin G, Badeker N, Vollmar J, Chaplin P. Safety, immunogenicity, and surrogate markers of clinical efficacy for modified vaccinia Ankara as a smallpox vaccine in HIV-infected subjects. J Infect Dis. 2013 Mar 1;207(5):749-58. doi: 10.1093/infdis/jis753. Epub 2012 Dec 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard N Greenberg, M.D. principal investigator
University of Kentucky School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMVAMUNE (MVA-BN) in people with HIV Infections, run by Bavarian Nordic at 5 sites in United States.
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 32 inclusion and 26 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 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. 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?
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study. 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 NCT00189904, which also lists 1 linked publication.
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 28 Sep 2012.