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Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT00282581•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 35 years

Sex

ALL

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.
+1 more criteria

Locations (6)

University of Alabama at Birmingham

Birmingham, Alabama, United States

AltaMed Health Services Corporation

Los Angeles, California, United States

Quest Clinical Research

San Francisco, California, United States

University of Miami AIDS Clinical Research Unit

Miami, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

University of Hawaii

Honolulu, Hawaii, United States

Key Dates

Start Date

October 1, 2006

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

January 22, 2014

Enrollment

ACTUAL participants

Conditions

HIV InfectionsSmallpox

Interventions

MVA Smallpox Vaccine

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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