Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
NCT ID: NCT00282581
Last Updated: 2014-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2006-10-31
2007-07-31
Brief Summary
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Detailed Description
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Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated. Excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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placebo
MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Interventions
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MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must test positive for HIV infection
* Subjects must be in good general health except for HIV infection, including no AIDS-defining illnesses.
* Female Subjects must not be pregnant or lactating, and all subjects must agree to practice birth control
* subjects must be clinically stable for 6 months prior to study enrollment.
Exclusion Criteria
* Subjects with history or prior exposure to a vaccinia-containing product
* subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions)
* Subjects with concomitant illnesses associated with impairment of immunologic function.
* subjects with dementia
* Subjects with malignancy.
* Subjects with a known history of Cardiac disease, or who have risk factors for ischemic coronary disease, or other abnormalities
* Current or past history of eczema
* known allergies to any component of MVA, including eggs or egg products, or allergies to blood products
* females must not be pregnant and using approved contraceptives.
* Morbid obesity
18 Years
35 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Margaret Fischl, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami AIDS clinical research unit
Rafael E Campo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Cecilia Shikuma, MD
Role: PRINCIPAL_INVESTIGATOR
University of Hawaii- Honolulu
Daniel Pearce, DO
Role: PRINCIPAL_INVESTIGATOR
AltaMed Health Services, Los Angeles
Jacob Lalezari, MD
Role: PRINCIPAL_INVESTIGATOR
Quest Clinical Research, San Francisco
Scott D Parker, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
AltaMed Health Services Corporation
Los Angeles, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
University of Hawaii
Honolulu, Hawaii, United States
Countries
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Related Links
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Related Info
Other Identifiers
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H-249-004
Identifier Type: -
Identifier Source: org_study_id
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