safety, tolerability and immune response of imvamune (mva-bn)smallpox vaccine in hiv infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in hiv infected populations.


Eligibility criteria:
inclusion criteria: * male subjects between 18 and 49 years of age or female subjects between 18 and 55 years of age who provided informed consent. * women with negative pregnancy test. * women of childbearing potential must use an acceptable method of contraception. * cardiac enzymes within uln. * white blood cells ≥ 2500/mm3 and \< 11,000/ mm3. * absolute neutrophil count ≥ 1000/mm3. * adequate renal function. * adequate hepatic function. * negative hepatitis b surface antigen (hbsag) and hepatitis b core antibody (anti-hbc). * negative antibody test to hepatitis c virus (hcv). * negative urine glucose by dipstick or urinalysis. * normal 12-lead electrocardiogram. * availability for follow-up during the study. groups 1 and 3 (all vaccinia-naïve subjects) additionally: * no history of known or suspected previous smallpox vaccination. * no detectable vaccinia scar. * no military service prior to 1989 or after january 2003. groups 2 and 4 (all previously vaccinated subjects) additionally: * history of at least one previous smallpox vaccination * time since most current smallpox vaccination \> 10 years. groups 1 and 2 (all hiv infected subjects) additionally: * documented hiv-1 infection * plasma hiv-1 rna level \< 400 copies/ml at screening. * cd4 cells ≥ 350/µl * haemoglobin ≥ 9.0 g/dl. * platelets ≥ 100,000/mm3. * ast (sgot), alt (sgpt) and alkaline phosphatase ≤ 3 x uln groups 3 and 4 (all healthy subjects) additionally: * negative elisa for hiv. * haemoglobin \>11 g/dl. * platelets ≥ 140,000/mm3. * ast (sgot), alt (sgpt) and alkaline phosphatase without clinically significant findings exclusion criteria: * pregnant or breast-feeding women. * uncontrolled serious infection i.e. not responding to antimicrobial therapy. * history of any serious medical condition (other than hiv infection). * history of or active autoimmune disease. * known or suspected impairment of immunologic function (other than hiv infection). * history of malignancy. * history or clinical manifestation of clinically significant and severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders. * clinically significant mental disorder not adequately controlled by medical treatment. * any condition which might interfere with study objectives. * 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 with onset of ischemic heart disease before age 50. * 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. * history of chronic alcohol abuse and/or intravenous drug abuse. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * known previous allergic reaction to immunoglobulins. * known allergies to cidofovir or probenecid. * history of anaphylaxis or severe allergic reaction. * acute disease (illness with or without a fever) at the time of enrollment. * temperature \>100.4°f at the time of enrollment. * subjects undergoing treatment for tuberculosis infection or disease. * 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 within 14 days prior or after study vaccination. * chronic administration of immuno-suppressant or immune-modifying drugs. * post organ transplant subjects whether or not receiving chronic immunosuppressive therapy. * administration or planned administration of immunoglobulins and/or any blood products. * use of any investigational or non-registered drug or vaccine.

Keywords: hiv