Safety Study of MVA Smallpox Vaccine in HIV-Positive Subjects Who Are Vaccinia Naive
This study has been terminated.
(Senior managemnt decision)
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00282581
First received: January 26, 2006
Last updated: January 14, 2009
Last verified: January 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Smallpox |
Biological: MVA Smallpox Vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Safety [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immunogenicity [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
| Enrollment: | 2 |
| Study Start Date: | October 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Biological: MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Other Name: placebo
|
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| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282581
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-2050 | |
| United States, California | |
| AltaMed Health Services Corporation | |
| Los Angeles, California, United States, 90022 | |
| Quest Clinical Research | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| University of Miami AIDS Clinical Research Unit | |
| Miami, Florida, United States, 33136 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Hawaii | |
| University of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
Sponsors and Collaborators
Sanofi
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 |
More Information
No publications provided
| Responsible Party: | Clinical Operations Manager, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00282581 History of Changes |
| Other Study ID Numbers: | H-249-004 |
| Study First Received: | January 26, 2006 |
| Last Updated: | January 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
HIV Smallpox MVA |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Smallpox Vaccinia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Poxviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on June 18, 2013