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

This study has been terminated.
(Senior managemnt decision)
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00282581
First received: January 26, 2006
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
HIV Infections
Smallpox
Biological: MVA Smallpox Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: October 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Biological: MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
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: NCT00282581

Locations
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
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

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00282581     History of Changes
Other Study ID Numbers: H-249-004
Study First Received: January 26, 2006
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
HIV
Smallpox
MVA

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Smallpox
DNA Virus Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Poxviridae 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 23, 2014