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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189904
First Posted: September 19, 2005
Last Update Posted: September 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Bavarian Nordic
September 11, 2005
September 19, 2005
September 28, 2012
July 2005
Not Provided
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study
Same as current
Complete list of historical versions of study NCT00189904 on ClinicalTrials.gov Archive Site
  • Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points)
  • ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points)
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients
A Multicenter, Open-label Phase I/II Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in HIV Infected Subjects (CD4 Counts >350 / µl) and Healthy Subjects With and Without Previous Smallpox Vaccination
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
Biological: IMVAMUNE (MVA-BN)
Not Provided
Greenberg RN, Overton ET, Haas DW, Frank I, Goldman M, von Krempelhuber A, Virgin G, Bädeker N, Vollmar J, Chaplin P. Safety, immunogenicity, and surrogate markers of clinical efficacy for modified vaccinia Ankara as a smallpox vaccine in HIV-infected subjects. J Infect Dis. 2013 Mar 1;207(5):749-58. doi: 10.1093/infdis/jis753. Epub 2012 Dec 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00189904
POX-MVA-010
HHSN266200400072C
Not Provided
Not Provided
Not Provided
Bavarian Nordic
Bavarian Nordic
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Richard N Greenberg, M.D. University of Kentucky School of Medicine
Bavarian Nordic
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP