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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00079820 |
Purpose
The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in the elimination of the natural disease. The last cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who work with smallpox-related viruses, military personnel, and health care workers are vaccinated.
Historically, individuals in the US were vaccinated with a product such as Dryvax®, which contains the virus vaccinia in the same family as smallpox. This virus could promote immunity to smallpox, but not produce the disease itself. Although effective, these vaccines are not safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens), children less than 1 year of age, and people with a compromised immune system, occurring in certain diseases (HIV positive individuals and AIDS), and following treatment with certain types of drugs. It is important to find a safe vaccine that can be used to protect people who cannot receive routine vaccinia-based smallpox vaccine.
The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the objective of this study to find out if MVA vaccine is safe and effective in providing immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The first way is to find out if there are specific antibodies in your blood following MVA vaccination. Antibodies are chemicals your body produces to fight smallpox virus.
The second way is to see whether or not there is a typical skin reaction following vaccination with a traditional smallpox vaccine, given about three months after vaccination with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is formation of a blister or "pox" which occurs at the site of vaccination. In a person with immunity to smallpox the skin reaction is much less, and typically consists of a little swelling at the site of vaccination.
| Condition | Intervention | Phase |
|---|---|---|
|
Smallpox |
Biological: ACAM3000 MVA Vaccine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | The Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination |
| Enrollment: | 110 |
| Study Start Date: | April 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
MVA3000 Smallpox vaccine (1x10-8) with Dryvax Challenge at Day 112
|
Biological: ACAM3000 MVA Vaccine
Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
|
|
B: Experimental
MVA3000 Smallpox vaccine (1x10-8) with no Challenge
|
Biological: ACAM3000 MVA Vaccine
Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
|
|
C: Placebo Comparator
Placebo
|
Biological: ACAM3000 MVA Vaccine
Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
|
|
D: Experimental
MVA3000 Smallpox vaccine (1x10-7) with Dryvax challenge at Day 112
|
Biological: ACAM3000 MVA Vaccine
Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
|
|
E: Experimental
MVA3000 Smallpox vaccine (1x10-6) with Dryvax challenge at Day 112
|
Biological: ACAM3000 MVA Vaccine
Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 31 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must meet the following to be eligible for the study:
Exclusion Criteria:
Any of the following exclusion criteria are met, the subject is NOT eligible.
Contacts and Locations| United States, Kansas | |
| PRA International | |
| Lenexa, Kansas, United States, 66219 | |
| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Study Director: | Medical Director | Sanofi Pasteur Inc |
More Information
| Responsible Party: | Sanofi Pasteur Inc ( Clinical Operations Manager ) |
| Study ID Numbers: | H-249-001 |
| Study First Received: | March 15, 2004 |
| Last Updated: | January 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079820 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Smallpox Smallpox Vaccine Variola virus Smallpox Virus MODIFIED VACCINIA ANKARA |
MVA Dryvax Dryvax vaccine Protection against smallpox |
|
Virus Diseases Smallpox Poxviridae Infections Vaccinia DNA Virus Infections |