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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections, Smallpox

Intervention / Treatment
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* Biological: MVA Smallpox Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Biological: MVA Smallpox Vaccine<br>* 0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Study Completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity |  | Study Completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Smallpox, MVA