Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00466245 |
Recruitment Status :
Completed
First Posted : April 27, 2007
Last Update Posted : January 22, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smallpox | Drug: MVA Smallpox vaccine Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 590 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2 Study Assessing Safety, Tolerability, Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara Smallpox Vaccine in Adults With and Without Previous Smallpox Vaccination |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Previously vaccinated for smallpox, 1x10-8 dose
|
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days |
Experimental: B
Smallpox vaccine naive, 1x10-8 dose
|
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days |
Experimental: C
Previous smallpox vaccination, 1x10-7 dose
|
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days |
Experimental: D
Smallpox vaccine naive, 1x10-7 dose
|
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days |
Experimental: E
Previous smallpox vaccination, 1x10-6 dose
|
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days |
Experimental: F
Smallpox vaccine naive, 1x10-6 dose
|
Drug: MVA Smallpox vaccine
Two 0.5mL subcutaneous injections, separated by 28 days |
Experimental: G
Previous smallpox vaccination, placebo dose
|
Drug: Placebo
Two 0.5mL subcutaneous injections, separated by 28 days |
Experimental: H
Smallpox vaccine naive, placebo dose
|
Drug: Placebo
Two 0.5mL subcutaneous injections, separated by 28 days |
- Safety [ Time Frame: Study Completion ]
- Immunogenicity [ Time Frame: Study Completion ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- subjects must be in good general health, checked on toxicity grading table.
- for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.
- for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.
- Female subjects must not be pregnant or lactating.
Exclusion Criteria:
- Subjects who participated in a "first responder" program.
- any history of immunodeficiency.
- any autoimmune disease
- any history of cardiac disease
- any diagnosed risk factors for ischemic coronary disease
- any history of heart palpitations or abnormalities in cardiac rhythm.
- any current or history of eczema of any description.
- Known allergy to MVA or any of its components, including eggs or egg products.
- 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): NCT00466245
Study Director: | Medical Monitor | Sanofi Pasteur Inc |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00466245 |
Obsolete Identifiers: | NCT00170651 |
Other Study ID Numbers: |
H-249-002 |
First Posted: | April 27, 2007 Key Record Dates |
Last Update Posted: | January 22, 2014 |
Last Verified: | January 2014 |
MVA Vaccine |
Smallpox Poxviridae Infections DNA Virus Infections Virus Diseases Infections |