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

This study has been terminated.

(Senior managemnt decision)

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00282581

First received: January 26, 2006

Last updated: January 14, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2006

Last Updated Date

January 14, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00282581 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Immunogenicity [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

HIV Infections
Smallpox

Intervention ^ICMJE

Biological: MVA Smallpox Vaccine

0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.

Other Name: placebo

Study Arm (s)

Placebo Comparator: placebo

Intervention: Biological: MVA Smallpox Vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00282581

Other Study ID Numbers ^ICMJE

H-249-004

Has Data Monitoring Committee

Yes

Responsible Party

Clinical Operations Manager, Sanofi Pasteur Inc.

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Sanofi

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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