Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00316589

Run by

Bavarian Nordic

People needed

581

Starts

2006-06-01

Expected to finish

2009-10-01

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Impairment of immunologic function (other than HIV infection).
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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