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Primary Objectives:
Secondary Objectives:
This is a prospective safety surveillance study in a US military Department of Defense (DoD) population. Military subjects either naive to smallpox immunization and have received ACAM2000® vaccine or who have previously been immunized with a vaccinia vaccine, usually Dryvax®, will be enrolled into the study.
No vaccine will be administered as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACAM2000 Smallpox Vaccine Group | Participants are vaccinia vaccine-naive and have received ACAM2000 Smallpox vaccine as part of their Service Member readiness process. | ||
| Other vaccinia vaccine Group | Participants did not receive ACAM2000 Smallpox vaccine as part of their Service Member readiness process because they are still protected by previous vaccinia vaccination or are ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition). |
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| Measure | Description | Time Frame |
|---|---|---|
| The percentage and rate per 1,000 of participants with subclinical, suspected, probable, or confirmed myopericarditis following vaccination with either ACAM2000® Smallpox vaccine or other vaccinia vaccine. | Day 10 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting dermatologic adverse events of rash following vaccination with either ACAM2000 or other vaccinia vaccine | Dermatologic adverse events of rash are those that meet the following criteria:
| Day 10 post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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Participants in Cohort 1 are vaccinia vaccine naive and had received ACAM2000® vaccine as part of their Service Member readiness.
Participants in Cohort 2 did not receive ACAM2000® vaccine as part of their Service Member readiness process because they are still protected by previous vaccinia vaccination or are ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition).
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Twentynine Palms | California | 92278 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32967791 | Derived | Faix DJ, Gordon DM, Perry LN, Raymond-Loher I, Tati N, Lin G, DiPietro G, Selmani A, Decker MD. Prospective safety surveillance study of ACAM2000 smallpox vaccine in deploying military personnel. Vaccine. 2020 Oct 27;38(46):7323-7330. doi: 10.1016/j.vaccine.2020.09.037. Epub 2020 Sep 20. |
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| ID | Term |
|---|---|
| D012899 | Smallpox |
| D014615 | Vaccinia |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Fort Campbell North |
| Kentucky |
| 42223 |
| United States |
| Fort Bliss | Texas | 79906 | United States |
| Fort Hood | Texas | 76544 | United States |