Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
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ClinicalTrials.gov Identifier: NCT00282581 |
Recruitment Status :
Terminated
(Senior managemnt decision)
First Posted : January 27, 2006
Last Update Posted : January 22, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Smallpox | Biological: MVA Smallpox Vaccine | Phase 1 |
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 (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, 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 |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: placebo |
Biological: MVA Smallpox Vaccine
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
Other Name: placebo |
- Safety [ Time Frame: Study Completion ]
- Immunogenicity [ Time Frame: Study Completion ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.
- Morbid obesity

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282581
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 |
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 |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00282581 |
Other Study ID Numbers: |
H-249-004 |
First Posted: | January 27, 2006 Key Record Dates |
Last Update Posted: | January 22, 2014 |
Last Verified: | January 2014 |
HIV Smallpox MVA |
Vaccinia Smallpox Infections |
Virus Diseases Poxviridae Infections DNA Virus Infections |