Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

Completed

• Conditions: Smallpox

• Registration Number: NCT00928577
• Lead Sponsor: Emergent BioSolutions

Brief Summary

Primary Objectives:

* To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.

* To identify cases of subclinical myopericarditis in deploying military subjects who received ACAM2000 vaccine.

Secondary Objectives:

* To compare the rates of severe and serious dermatologic adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.

* To compare the rates of severe and serious neurological adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.

* To compare the rates of adverse events observed in subjects approximately 10 days following their ACAM2000® vaccination to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.

* To evaluate potential risk factors associated with the development of confirmed, probable, and/or suspected ACAM2000-associated myopericarditis.

Detailed Description

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of participants reporting dermatologic adverse events of rash following vaccination with either ACAM2000 or other vaccinia vaccine	Day 10 post-vaccination	Dermatologic adverse events of rash are those that meet the following criteria: * Serious rashes persisting more than 48 hours that are distant from the vaccination site and; * associated with systemic symptoms, or; * involving mucous membranes.