Phase I Safety Study of a Recombinant MVA HIV Multiantigen Vaccine in HIV-infected Subjects

A Phase 1 study testing MVA-mBN120B in people with HIV Infections, run by Bavarian Nordic at 1 site in United States.

Completed

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

Trial summary

Monocentric study to assess the safety and immunogenicity of the recombinant MVA-HIV multiantigen vaccine MVA-mBN120B in HIV-infected subjects. 15 subjects will receive immunizations at day 0, after 4 and 12 weeks at a dose of 2E8 TCID50 MVA-mBN120B. The vaccine will be administered subcutaneously. 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?: MVA-mBN120B
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: May 2008to Apr 2009
Phase: Phase 1
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
No healthy volunteers
Adult

Who may be able to join

Male and female subjects aged between 18 to 55 years.
HIV-1 infection documented by either plasma HIV-1 RT-PCR or bDNA assay at any time prior to study entry.
Stable on HAART with regard to immunologic and clinical parameters for at least 6 consecutive months prior to study entry (substitutions of one drug for another in the same class due to reasons other than virologic failure are allowed).
Plasma HIV RNA level < 50 copies/ml for at least 6 months prior to study entry; single blips of up to 400 HIV-1 RNA copies/ml are acceptable if they resolve spontaneously without a change in HAART.
Plasma HIV-1 RNA levels of < 50 copies/ml at study entry.
Women with childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to immunization.

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Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first immunization, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last immunization. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
CD4 cells ≥ 350/µl (two determinations, of which one must be done during the screening and the other must be done within 3 months before study entry)
CD4 nadir > 150/µl.
Troponin I within normal institutional limits.
White blood cells ≥ 2500/mm3 and < = 11,000/ mm3.
Negative urine glucose by dipstick or urinalysis at screening.
Haemoglobin ≥ 9.0g/dL.
Platelets ≥ 100,000/mm3
Adequate renal function defined as:
Calculated Creatinine clearance (CrCl) > 50 mL/min as estimated by the Cockroft-Gault equation.
Urine protein < = 100 mg/dL or none or trace proteinuria (by urinalysis or dip stick (< = 2+ proteinuria)).
Adequate hepatic function defined as:
Total bilirubin < = 2 x ULN unless elevation is explained by antiviral therapy and in the absence of other evidence of significant liver disease (healthy subjects without clinical disease with Gilbert's Syndrome can be included).
AST (SGOT), ALT (SGPT) and alkaline phosphatase < = 3 x ULN without clinically significant findings.
Electrocardiogram (ECG) without abnormal findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV-node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia).
Negative test for hepatitis B surface Antigen (HBsAg) and hepatitis C antibody (HCV Ab).
Free of obvious health problems as established by medical history and physical examination before entering into the study.
Signed informed consent form of the subject after information of the risks and benefits of the study in a language the subject clearly understands, and before any study specific procedure.
Availability for follow-up for the planned duration of the study.

Who cannot join

Pregnant or breast-feeding women.
Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
History of suspected or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement therapy are not excluded.
History of chronic alcohol abuse (40g / day for at least 6 months) and/or intravenous drug abuse (within the past 6 months).
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. Subjects with history of skin cancer at the vaccination site are excluded.

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Manifestation of clinically significant and severe haematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorder.
Clinically significant mental disorder not adequately controlled by medical treatment.
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.
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 (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
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.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Known allergy to egg or aminoglycoside (gentamicin).
History of anaphylaxis or severe allergic reaction.
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 within14 days prior or after study vaccination.
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).
Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
Any continuous therapy that may influence CD4 counts other than antiretroviral therapy.
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.
Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is longer) preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
Previous participation in another HIV vaccination study.
Previous participation in any MVA vaccination study during the last 5 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase I Vaccination Study Testing the Safety and Reactogenicity of a Recombinant MVA HIV Multiantigen Vaccine (MVA-mBN120B) in HIV-infected Subjects With CD4 Count > 350/µL

Conditions: HIV Infections
Being tested: MVA-mBN120B
Medical subject headings: HIV Infections

What participants receive

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

MVA-mBN120BBiological

Study groups in NCT00623259
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: MVA-mBN120B

Timeline

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

May 2008Apr 2009

First posted26 Feb 2008 (estimated)
Study startMay 2008
Primary completionFeb 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Primary purpose: Diagnosis
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00623259
Sponsor's protocol ID: HIV-MAG-001
Status last verified: May 2010
First submitted: 19 Feb 2008
Last updated: 20 May 2010
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Vaccination Study Testing the Safety and Reactogenicity of a Recombinant MVA HIV Multiantigen Vaccine (MVA-mBN120B) in HIV-infected Subjects With CD4 Count > 350/µL
ClinicalTrials.gov ID: NCT00623259
Acronym / sponsor ID: HIV-MAG-001
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (estimated)
Lead sponsor: Bavarian NordicIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Feb 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 26 Feb 2008 (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.

Study design

Primary purpose: Diagnosis
Number of arms: 1

Arm	Type	Receives
1	Experimental	Biological: MVA-mBN120B

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (25 listed)

Male and female subjects aged between 18 to 55 years.
HIV-1 infection documented by either plasma HIV-1 RT-PCR or bDNA assay at any time prior to study entry.
Stable on HAART with regard to immunologic and clinical parameters for at least 6 consecutive months prior to study entry (substitutions of one drug for another in the same class due to reasons other than virologic failure are allowed).
Plasma HIV RNA level < 50 copies/ml for at least 6 months prior to study entry; single blips of up to 400 HIV-1 RNA copies/ml are acceptable if they resolve spontaneously without a change in HAART.
Plasma HIV-1 RNA levels of < 50 copies/ml at study entry.

Key exclusion criteria (24 listed)

Pregnant or breast-feeding women.
Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
History of suspected or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement therapy are not excluded.
History of chronic alcohol abuse (40g / day for at least 6 months) and/or intravenous drug abuse (within the past 6 months).

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
MVA-mBN120B	Biological	1

Primary outcome

Not reported in the source record.

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 20 May 2010.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
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HIV, Substance Use Disorder

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA-mBN120B in people with HIV Infections, run by Bavarian Nordic at 1 site 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 25 inclusion and 24 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 20 May 2010. 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 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 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.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00623259.

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 20 May 2010.