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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

January 26, 2006
January 17, 2014
October 2006
July 2007   (final data collection date for primary outcome measure)
Safety [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00282581 on ClinicalTrials.gov Archive Site
Immunogenicity [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Smallpox
Biological: MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Other Name: placebo
Placebo Comparator: placebo
Intervention: Biological: MVA Smallpox Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00282581
H-249-004
Yes
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
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
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP