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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:
Collaborator:
Information provided by (Responsible Party):
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00189904
First received: September 11, 2005
Last updated: September 27, 2012
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
HIV Infections
Biological: IMVAMUNE (MVA-BN)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

Primary Outcome Measures:
  • Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study

Secondary Outcome Measures:
  • 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)

Enrollment: 151
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189904

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202-2859
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0093
United States, Missouri
Washington University School of Medicine
St.Louis, Missouri, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6073
United States, Tennessee
Vanderbilt AIDS Clinical Trials Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Richard N Greenberg, M.D. University of Kentucky School of Medicine
  More Information

No publications provided by Bavarian Nordic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00189904     History of Changes
Other Study ID Numbers: POX-MVA-010, HHSN266200400072C
Study First Received: September 11, 2005
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bavarian Nordic:
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014