Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®) - Full Text View

Purpose

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.

Condition	Phase
Smallpox	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Phase IV Prospective Safety Surveillance Cohort Study Of ACAM2000® In Deploying Military Personnel

Resource links provided by NLM:

MedlinePlus related topics: Smallpox

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of participants reporting dermatologic adverse events of rash following vaccination with either ACAM2000 or other vaccinia vaccine [ Time Frame: Day 10 post-vaccination ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	20000
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
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).

Groups/Cohorts

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).

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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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).

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928577

Contacts

Contact: Public Registry Sanofi Pasteur

RegistryContactUs@sanofipasteur.com

Locations

United States, California
	Recruiting
Twentynine Palms, California, United States, 92278
United States, Kentucky
	Recruiting
Ft Campbell, Kentucky, United States, 42223
United States, Texas
	Recruiting
Ft. Bliss, Texas, United States, 79906
	Recruiting
Ft. Hood, Texas, United States, 76544

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00928577 History of Changes
Other Study ID Numbers:	H-406-004
Study First Received:	June 25, 2009
Last Updated:	April 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi:

Smallpox
Smallpox Vaccine
Vaccinia virus
Military

Additional relevant MeSH terms:

Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013