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Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive

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ClinicalTrials.gov Identifier: NCT00282581
Recruitment Status : Terminated (Senior managemnt decision)
First Posted : January 27, 2006
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection

Condition or disease Intervention/treatment Phase
HIV Infections Smallpox Biological: MVA Smallpox Vaccine Phase 1

Detailed Description:

This is a multi-center study 90 HIV-seropositive subjects. There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Double-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus (HIV)-Seropositive Subjects
Study Start Date : October 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Smallpox

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo Biological: MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: Study Completion ]

Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: Study Completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product
  • 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 a known or suspected history of immunodeficiency (with the exception of HIV infection)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282581


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2050
United States, California
AltaMed Health Services Corporation
Los Angeles, California, United States, 90022
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Florida
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States, 33136
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96816
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Margaret Fischl, MD University of Miami AIDS clinical research unit
Principal Investigator: Rafael E Campo, MD University of Miami
Principal Investigator: Cecilia Shikuma, MD University of Hawaii- Honolulu
Principal Investigator: Daniel Pearce, DO AltaMed Health Services, Los Angeles
Principal Investigator: Jacob Lalezari, MD Quest Clinical Research, San Francisco
Principal Investigator: Scott D Parker, MD University of Alabama at Birmingham
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00282581    
Other Study ID Numbers: H-249-004
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
HIV
Smallpox
MVA
Additional relevant MeSH terms:
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Vaccinia
Smallpox
Virus Diseases
Poxviridae Infections
DNA Virus Infections