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

January 17, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2050
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90022
        • AltaMed Health Services Corporation
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Miami, Florida, United States, 33136
        • University of Miami AIDS Clinical Research Unit
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • University of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Biological: MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: Study Completion
Study Completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity
Time Frame: Study Completion
Study Completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Investigators

  • Principal Investigator: Margaret Fischl, MD, University of Miami AIDS Clinical Research Unit
  • Principal Investigator: Rafael E Campo, MD, University of Miami
  • Principal Investigator: Cecilia Shikuma, MD, University of Hawaii- Honolulu
  • Principal Investigator: Daniel Pearce, DO, AltaMed Health Services, Los Angeles
  • Principal Investigator: Jacob Lalezari, MD, Quest Clinical Research, San Francisco
  • Principal Investigator: Scott D Parker, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-249-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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