Status:
COMPLETED
Safety and Immunogenicity Study of Recombinant Modified Vaccinia Virus Ankara (MVA) Virus to Treat HIV Infection
Lead Sponsor:
Bavarian Nordic
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 (Joint United Nations Programme on HIV/AIDS \[UNAIDS\], 2004). ...
Eligibility Criteria
Inclusion
- Age 18 - 50
- Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to vaccination.
- Women of childbearing potential must have used an acceptable method of contraception.
- Troponin I within normal institutional limits.
- Adequate renal function
- Adequate hepatic function
- Electrocardiogram (ECG) without abnormal findings
- Negative HIV test for HIV-1 prior to immunization
- HLA-A2, HLA-A3 or HLA-B7 positive.
- Written informed consent of the subject after information of the risks and benefits of the study are provided in a language the subject clearly understands, and before any study specific procedure.
- Ultrasound of the abdomen without clinically significant abnormalities.
Exclusion
- 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 or suspected or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
- 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.
- 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).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00386633
Start Date
October 1 2006
End Date
November 1 2007
Last Update
January 27 2015
Active Locations (1)
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1
LMU-Munich, Department of Infectious Diseases and Tropical Medicine
Munich, Germany, 80799