Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

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.

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Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Vaccinia Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Twentynine Palms, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent obtained prior to the conduct of any study-related procedures.
Male and Female military personnel positioned for active deployment.
Participant naïve to previous smallpox vaccination and received the ACAM2000 vaccine (Cohort 1), OR, Participant has not received ACAM2000 vaccine within the prior 3 years, AND is 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) (Cohort 2).

Exclusion criteria

Subjects judged by the investigator as unlikely to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits.
Participation in any other studies involving investigational or marketed products within 30 days prior to Visit 1.

Treatment and study plan

Primary outcomes

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.

Time frame: Day 10 post-vaccination

Secondary outcomes

Number of participants reporting dermatologic adverse events of rash following vaccination with either ACAM2000 or other vaccinia vaccine

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Registry information

Official study title

A Phase IV Prospective Safety Surveillance Cohort Study Of ACAM2000® In Deploying Military Personnel

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2015
First posted: Jun 26, 2009
Registry last updated: Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed