NCT00282581TerminatedPhase 1
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
Sanofi Pasteur, a Sanofi Company12 sites in 1 country2 target enrollmentStarted: October 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 2
- Locations
- 12
- Primary Endpoint
- Safety
Study Overview
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
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Safety
Time Frame: Study Completion
Secondary Outcomes
- Immunogenicity(Study Completion)
Investigators
Study Sites (12)
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