Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
NCT ID: NCT00316589
Last Updated: 2019-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
581 participants
INTERVENTIONAL
2006-06-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Healthy subjects
Control group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)
IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
HIV-infected, vaccinia-naive
Subjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
HIV-infected, vaccinia-experienced
Subjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Interventions
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IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy volunteers are accepted
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Bavarian Nordic
INDUSTRY
Responsible Party
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Principal Investigators
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Edgar Turner Overton, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Alabama Vaccine Research Clinic; University of Alabama at Birmingham
Birmingham, Alabama, United States
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States
Providence Clinical Research
Burbank, California, United States
Northern California Research
Carmichael, California, United States
CSI Clinical Trials, Inc.
Fountain Valley, California, United States
AltaMed Health Services
Los Angeles, California, United States
Alta Bates Summit Medical Center, East Bay AIDS Center
Oakland, California, United States
Benchmark Clinical Research
San Francisco, California, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Consultive Medicine
Daytona Beach, Florida, United States
Northpoint Medical, PA
Fort Lauderdale, Florida, United States
The Kinder Medical Group
Miami, Florida, United States
Infectious Diseases of NW Florida
Pensacola, Florida, United States
Palm Beach Center
West Palm Beach, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
The CORE Center
Chicago, Illinois, United States
Northstar Medical Center
Chicago, Illinois, United States
Indiana University School of Medicine; Division of Infectious Disease
Indianapolis, Indiana, United States
University of Iowa, Division of Infectious Diseases
Iowa City, Iowa, United States
Nemechek Health Renewal
Kansas City, Missouri, United States
St. Louis University, Center for Vaccine Dev.
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Immuniodeficiency Clinic, ECMC
Buffalo, New York, United States
Universtity of Rochester School of Medicine
Rochester, New York, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Clinical Trials Research Services
Pittsburgh, Pennsylvania, United States
Brown Medical School
Providence, Rhode Island, United States
University of South Carolina
Columbia, South Carolina, United States
Vanderbilt University, AIDS Clinical Trials Center
Nashville, Tennessee, United States
Nicholaos C. Bellos, MD PA
Dallas, Texas, United States
Valley AIDS Council
Harlingen, Texas, United States
Diversified Medical Practices
Houston, Texas, United States
Clinical Research P.R., Inc.
San Juan, , Puerto Rico
Maternal Infant Studies Center (CEMI)
San Juan, , Puerto Rico
Countries
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References
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Overton ET, Stapleton J, Frank I, Hassler S, Goepfert PA, Barker D, Wagner E, von Krempelhuber A, Virgin G, Meyer TP, Muller J, Badeker N, Grunert R, Young P, Rosch S, Maclennan J, Arndtz-Wiedemann N, Chaplin P. Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial. Open Forum Infect Dis. 2015 May 5;2(2):ofv040. doi: 10.1093/ofid/ofv040. eCollection 2015 Apr.
Other Identifiers
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POX-MVA-011
Identifier Type: -
Identifier Source: org_study_id
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