Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
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
1 other identifier
interventional
590
0 countries
N/A
Brief Summary
A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedJanuary 22, 2014
January 1, 2014
11 months
April 25, 2007
January 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Study Completion
Secondary Outcomes (1)
Immunogenicity
Study Completion
Study Arms (8)
A
EXPERIMENTALPreviously vaccinated for smallpox, 1x10-8 dose
B
EXPERIMENTALSmallpox vaccine naive, 1x10-8 dose
C
EXPERIMENTALPrevious smallpox vaccination, 1x10-7 dose
D
EXPERIMENTALSmallpox vaccine naive, 1x10-7 dose
E
EXPERIMENTALPrevious smallpox vaccination, 1x10-6 dose
F
EXPERIMENTALSmallpox vaccine naive, 1x10-6 dose
G
EXPERIMENTALPrevious smallpox vaccination, placebo dose
H
EXPERIMENTALSmallpox vaccine naive, placebo dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sanofi Pasteur Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
July 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
January 22, 2014
Record last verified: 2014-01