Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

NCT00928577 | Completed

• 1 other identifier: H-406-004
• Study Type: observational
• Target: 14,108
• Locations: 1 country
• Sites: 4

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.

Conditions

Smallpox

Keywords

Smallpox; Smallpox Vaccine; Vaccinia virus; Military

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day 10 post-vaccination

Study Arms (2)

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).

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead

Study Sites (4)

Unknown Facility

Twentynine Palms, California, 92278, United States

Location

Unknown Facility

Fort Campbell North, Kentucky, 42223, United States

Location

Unknown Facility

Fort Bliss, Texas, 79906, United States

Location

Unknown Facility

Fort Hood, Texas, 76544, United States

Location

Related Publications (1)

• 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.

  PMID: 32967791 DERIVED

MeSH Terms

Conditions

Smallpox; Vaccinia

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Medical Director

  Emergent BioSolutions

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

US (4)