Status:
COMPLETED
An Evaluation of Immunogenicity and Safety of Two Doses of MVA-nef vs. MVA-BN in HIV-1 Infected Patients
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
HIV Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The objective of the study is to compare two doses of MVA-nef vs. MVA-BN to induce Nef-specific cellular immune response in HIV-1 infected patients
Eligibility Criteria
Inclusion
- Ages 18-60
- HIV-1 infection, as documented by any licensed PCR kit or ELISA (confirmed by an complementary assay e.g. Western blot HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA) at any time prior to study entry.
- Stable on HAART for at least 6 consecutive months prior to study entry (changes of one drug for the another drug due to reasons other than virologic failure are allowed)
- Plasma HIV-1 RNA levels of \< 50 copies/ml for at least 6 months prior to study entry (two single blips of up to 200 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
- CD4 nadir \>100
- CD4+ cell counts \> 250/µl (one measurement within 4 months prior to study entry and one measurement within screening phase)
- For women, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination.
- If the volunteer is female and of childbearing potential, she agrees to use an acceptable method of contraception, and not become pregnant for at least 56 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) with use of method for a minimum of 30 days prior to vaccination).
- ALT/SGPT, AST/SGOT, and alkaline phosphatase \< 3 times institutional upper limit of normal (ULN).
- Urine protein by dipstick or urinalysis \< 100mg/dl or \<2+ proteinuria
- CBC: Haemoglobin \>8 g/dl; White blood cells greater than 2,500 and less than 11,000/mm3; Platelets greater than or equal to 100,000/mm3
- Read, signed and dated informed consent document after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure
- Cardiac enzymes: within normal range.
Exclusion
- Pregnant or breast-feeding women.
- Administration of any HIV nef vaccine or vaccinia immunization within the past 5 years.
- 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 or active autoimmune disease. Persons with vitiligo or thyroid disease on thyroid replacement are not excluded.
- 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 or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator.
- ECG with clinical significance (complete left or right bundle branch block, or sustained ventricular arrythmia, or 2 PVCs in a row, or ST elevation consistent with ischemia).
- History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
- 3 or more of the following risk factors:
- High blood pressure requiring therapy.
- High blood cholesterol (\> 300 mg/dl or ratio LDL/HDL ≥ 3) not induced by the HIV therapy.
- Diabetes mellitus or high blood sugar.
- He/she has a first degree relative (for example mother, father, brother, or sister) who had a heart condition before the age of 50.
- Smoking cigarettes now.
- History of chronic alcohol abuse (40g / day for at least 6 month) 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 vaccinations with active 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 inactive vaccines within a period starting 14 days prior to administration of the vaccine and ending 14 days after administration of the study vaccine.
- Chronic administration (defined as more than 14 days) of immuno- suppressant or immune-modifying drugs during the study period (Corticosteroid nasal sprays are permissible. Subjects who have used topical and inhaled steroids can be enrolled after their therapy is completed).
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00189930
Start Date
April 1 2005
End Date
December 1 2006
Last Update
October 1 2012
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Erlangen
Erlangen, Bavaria, Germany, 91054
2
Doctor's Practice
Fürth, Bavaria, Germany, 90762
3
Doctor's Practice
Munich, Bavaria, Germany, 80335
4
Doctor's Practice
Munich, Bavaria, Germany, 80801