Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, treatment experienced, treatment vaccinia naive
Eligibility Criteria
Genders eligible for Study: Both Age: between 18 and 55 years Healthy volunteers are accepted Inclusion Criteria: Subjects tested positive for HIV-1 infection (HIV-infected subjects). Subjects that are tested negative for HIV (Healthy subjects). Either on stable antiretroviral therapy or not on antiretroviral therapy. CD4 cells > = 200 - 750/µl. Subjects must be in good general health except for HIV infection. Women must not be pregnant and use an acceptable method of contraception. Exclusion Criteria: Impairment of immunologic function (other than HIV infection). History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure. Uncontrolled serious infection. History of or active autoimmune disease. History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years. High risk of developing a myocardial infarction or coronary death. History of intravenous drug abuse (within the last 12 months). Known allergy to egg or aminoglycoside (gentamicin). History of anaphylaxis or severe allergic reaction. Subjects undergoing treatment for tuberculosis infection or disease. Chronic administration of systemic immuno-suppressants.
Sites / Locations
- Alabama Vaccine Research Clinic; University of Alabama at Birmingham
- Health for Life Clinic, PLLC
- Providence Clinical Research
- Northern California Research
- CSI Clinical Trials, Inc.
- AltaMed Health Services
- Alta Bates Summit Medical Center, East Bay AIDS Center
- Benchmark Clinical Research
- Clinical Research of West Florida
- Consultive Medicine
- Northpoint Medical, PA
- The Kinder Medical Group
- Infectious Diseases of NW Florida
- Palm Beach Center
- Atlanta ID Group
- The CORE Center
- Northstar Medical Center
- Indiana University School of Medicine; Division of Infectious Disease
- University of Iowa, Division of Infectious Diseases
- Nemechek Health Renewal
- St. Louis University, Center for Vaccine Dev.
- Washington University School of Medicine
- University of Nebraska Medical Center
- Immuniodeficiency Clinic, ECMC
- Universtity of Rochester School of Medicine
- University of Oklahoma
- University of Pennsylvania
- Clinical Trials Research Services
- Brown Medical School
- University of South Carolina
- Vanderbilt University, AIDS Clinical Trials Center
- Nicholaos C. Bellos, MD PA
- Valley AIDS Council
- Diversified Medical Practices
- Clinical Research P.R., Inc.
- Maternal Infant Studies Center (CEMI)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Healthy subjects
HIV-infected, vaccinia-naive
HIV-infected, vaccinia-experienced
Control group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)
Subjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
Subjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)