Status:
COMPLETED
Single-Blind, Controlled Safety and Immunogenicity Study of Recombinant MVA Virus to Treat HIV Infection
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief 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 part...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- 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.
- EXCLUSION CRITERIA:
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00390078
Start Date
January 1 2007
End Date
January 1 2009
Last Update
July 10 2009
Active Locations (1)
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1
Charité, Campus Virchow-Klinikum
Berlin, Germany, 13353