Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients

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: 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.

Relevance to patient case: not relevant