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

Phase 1

Terminated

• Conditions: Smallpox; HIV Infections
• Interventions: Biological: MVA Smallpox Vaccine

• Registration Number: NCT00282581
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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 Timeline

• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-27
• Study Start: 2006-10
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	MVA Smallpox Vaccine	-

Primary Outcome Measures

Name	Time	Method
Safety	Study Completion

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	Study Completion

Trial Locations

Locations (6)

University of Miami AIDS Clinical Research Unit; 🇺🇸 Miami, Florida, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

University of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

AltaMed Health Services Corporation; 🇺🇸 Los Angeles, California, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States