Trial | NCT00282581  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    mva ...

  • Study Participants

    2
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.
Study Started
Oct 31
2006
Primary Completion
Jul 31
2007
Study Completion
Jul 31
2007
Last Update
Jan 22
2014
Estimate

Biological MVA Smallpox Vaccine

0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.

  • Other names: placebo

placebo Placebo Comparator

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
No Results Posted